Take 1 capsule three times per day, 30 minutes before food, or as directed by a qualified health care practitioner.
Get Rid of Colds and Cold Symptoms Faster
Advanced Cold Complex is the natural go-to formula for those who do not want to catch the cold and flu, speed up recovery faster, and those who are prone to more severe respiratory complications when they get sick.
Advanced Cold Complex is a comprehensive cold and flu relief formula containing Pelargonium sedoides (South African geranium), Tinospora cordifolia (Guduchi) and Andrographis panniculata. These plant extracts are proven to boost the immune system, prevent the onset of colds and flu and reduce the symptoms of viral and bacterial upper respiratory tract infections including coughing, sneezing, congestion, fever, sore throat and runny nose.
This cold complex helps reduce the duration of of a cold/flu and reduce the intensity of symptoms quickly. Pelargonium reduces the ability of bacteria to adhere to the cells in the respiratory tract and helps your body expel them more easily. Pelargonium and Andrographis help reduce how often you catch a cold, how bad the cold is and how long it lasts. Tinospora and Pelargonium work powerfully in the nasal region and reduce nasal congestion, discharge and sneezing. Tinospora has been found especially effective in reducing nasal symptoms in allergic rhinitis and rhinosinusitis. Pelargonium and Andrographis are also helpful for more severe respiratory infections than just the common cold.
AOR’s Advanced Cold complex is the ultimate, evidence based herbal combination to support immune function and reduce the symptoms and duration of a sore throat, the flu, sinusitis and upper respiratory tract infections.
Advanced Cold Complex™ is an advanced herbal cold relief formula that helps reduce symptoms of the common cold and upper respiratory tract infections.
|Amount Per Serving Amount: 1 Capsule|
|10 mg South African Geranium (Pelargonium sidoides)|
|300 mg Tinospora cordifolia 10:1 extract|
|50 mg Andrographis paniculata extract (33% andrographolides)|
|Non-medicinal ingredients: microcrystalline cellulose, sodium stearyl fumarate, silicon dioxide, potato starch. Capsule: hypromellose.|
AOR™ guarantees that no ingredients not listed on the label have been added to the product. Contains no wheat, gluten, corn, peanuts, sesame seeds, sulphites, mustard, dairy, soy, eggs, fish, shellfish, or any animal byproduct.
Take 1 capsule three times per day, 30 minutes before food, or as directed by a qualified health care practitioner.
Consult a health care practitioner prior to use if you are taking anticoagulants, antiplatelet medication, hypotensive medications or supplements, immunosuppressants or any other medication, if symptoms persist or worsen, or for use beyond 7 days. Gastrointestinal discomfort (i.e. diarrhea) has been known to occur. Hypersensitivity has been known to occur, in which case discontinue use. Do not use if pregnant or breastfeeding.
Do not use
Natural botanical extracts
The information and product descriptions appearing on this website are for information purposes only, and are not intended to provide or replace medical advice to individuals from a qualified health care professional. Consult with your physician if you have any health concerns, and before initiating any new diet, exercise, supplement, or other lifestyle changes.
Advanced Cold Complex is a comprehensive cold formula consisting of Pelargonium sedoides, Andrographis panniculata and Tinospora cordifolia. These plant extracts have been proven to boost the immune system and reduce the symptoms and frequency of viral and bacterial upper respiratory tract infections. This cold complex helps get rid of a cold and its symptoms quicker and reduces the risk of respiratory complications that may develop from or be exacerbated by such infections. It may help to reduce the risk of developing the symptoms of bronchitis.
Pelargonium sedoides or Umcka (Umckaloabo) is a species of geranium native to southern Africa. Its roots are used medicinally for the treatment of various types of bacterial and viral illnesses of the lungs. It is most frequently used for treating the common cold in Austria, Belgium and Hungary, as a symptomatic treatment for acute bronchitis in the Czech Republic, and for acute infections of the upper airways in Germany.
It acts as an immune stimulant due to a combination of the phenolic compounds and coumarins present in it. It helps to stimulate beneficial nitric oxide production, has anti-inflammatory effects on nasal epithelial cells, protects against mycobacteria growth, and has antibacterial and antiviral effects due to gallic acids and other phenolic compounds present. It’s most significant advantage for fighting against bacterial infections is its ability to protect the upper respiratory tract from bacterial colonization. It does this by reducing the ability of bacteria to adhere to the cells in the respiratory tract. In contrast, the attachment of bacteria to buccal epithelial cells (cells which produce mucous membranes) is enhanced, so that the pathogens are released during coughing and eventually inactivated by being swallowed. Pelargonium also increases the activity of the cilia, tiny hairs that protect the nasal passageways and other parts of the respiratory tract, filtering out dust and other particles that enter the nose with breathed air.
Tinospora cordifolia or Guduchi is an herbaceous vine of the family Menispermaceae, indigenous to the tropical areas of India, Myanmar and Sri Lanka. The plant has a long history of use in India as a medicine. It has been used effectively as a treatment for allergic rhinitis.
Tinospora cordifolia contains several chemical components that exert an effect on the body. Some of these components have antioxidant effects. Others are able to increase the activity of the body’s immune system. A variety of active components derived from the plant such as alkaloids, steroids, diterpenoid lactones, aliphatics and glycosides have been isolated from the different parts of the plant including root, stem and whole plant. Recently, the plant has generated interest from researchers across the globe because of its reported medicinal properties such as anti-diabetic, anti-periodic, anti-spasmodic, anti-inflammatory, anti-arthritic, anti-oxidant, anti-allergic, anti-stress, anti-leprotic, anti-malarial, hepatoprotective, immunomodulatory and anti-neoplastic activities.
Andrographis paniculata is a plant found primarily in Asia and India. In Traditional Chinese Medicine, it is used to remove heat, counteract toxicity and reduce swelling. In Ayurvedic and Thai medicine, it is used to treat fever associated with infectious diseases, and Scandinavians have traditionally used it as a cold and flu remedy, which is supported by at least 7 well-structured clinical trials.
The major active components are diterpene lactones called andrographolides with several similar sub-components such as neoandrographolides and dehydroandrographolides. Various beneficial effects have been identified for each sub-component, ranging from immune-modulating to cardiovascular, anti-microbial and anti-inflammatory benefits.
Clinical evidence supports its ability to reduce symptoms and even the occurrence of upper respiratory tract infections (URTIs) like the common cold and sinusitis, bronchitis, pharyngotonsillitis and pneumonia. This is very relevant for two reasons. The first is that Andrographis could potentially help reduce the over-prescription of antibiotics, which could help reduce drug-resistant superbugs. Secondly, evidence shows that antibiotics don’t even shorten acute viral infections or prevent the secondary bacterial infections that accompany them! Andrographis could be of assistance in both cases.
Cold remedies are popular health supplements which consumers turn to when trying to prevent or recover from viral and bacterial infections, some of which are very contagious. Some of the most commonly purchased natural remedies include Echinacea and ginseng. Antibiotics are commonly prescribed for bacterial infections but also carry the risk of having negative side effects such as disturbing the gut microflora. Pelargonium sedoides, Tinospora cordifolia and Andrographis paniculata are herbal extracts that are not yet well-known in the supplement market, but their positive clinical evidence exceeds that of Echinacea.
AOR introduces Pelargonium, Tinospora and Andrographis, which are innovative, unique and effective plant extracts not yet well known to the Canadian supplement market. AOR has developed an innovative and comprehensive cold complex that helps to prevent and reduce the symptoms and duration of the common cold and other upper respiratory tract infections as well as reduce the risk of developing further respiratory complications such as bronchitis. Research has demonstrated that these ingredients are highly effective for helping the body utilise its natural defenses for recovering from illness.
Pelargonium proved to be an effective and well-tolerated treatment option for children and adolescents suffering with acute bronchitis. Treatments were administered for 7 days, but were administered only if there was not a strict indication for antibiotics. In another study in adults, treatment was shown to be clinically effective with statistically significant results demonstrating improvement in acute bronchitis symptoms as compared to a control group.
In a study on athletes, results showed that a Pelargonium sidoides extract modulates the production of immune factors to help reduce the negative impact that exercise has on the immune system. Based on this evidence, researchers found that Pelargonium can exert a strong modulating influence on the immune response associated with the upper airway mucosa in athletes involved in intense physical activity and help to prevent immune system depression.
Pelargonium was found to be well tolerated and superior in efficacy compared to placebo in the treatment of acute rhinosinusitis of presumed bacterial origin. One study demonstrated that the course of the disease was more favorable in terms of the severity of symptoms and the duration of the illness was markedly decreased.
Pelargonium has been demonstrated as an effective treatment of the common cold. In research studies it was found to significantly reduce the severity of symptoms and shorten the duration of the common cold compared with a placebo group. The following 10 cold symptoms were reduced with the use of pelargonium: nasal drainage, sore throat, nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches and fever. Pelargonium helps to prevent the adhesion of bacteria and viruses to the epithelial cells, while increasing their adhesion to buccal cells that can be expelled from the body to reduce viral and bacterial load in the body.
Chronic Obstructive Pulmonary Disease (COPD)
Research studies have demonstrated that Pelargonium helps to reduce the frequency and duration of COPD exacerbations. A supplement containing Pelargonium was well tolerated over a long term treatment period in patients with moderate to severe COPD. It also allowed patients to reduce their use of antibiotic medications.
In a study on children, Pelargonium sidoides helped to prevent asthma attacks during upper respiratory tract viral infections when it was administered for a 5 day treatment period. There were significant differences in symptom reduction between the control group and those taking Pelargonium including cough frequency and nasal congestion. The Pelargonium sidoides group had reduced symptoms and also had decreased frequency of respiratory attacks.
Pelargonium was superior compared to placebo for the treatment of acute non-GABHS tonsillopharyngitis in children. Treatment with Pelargonium reduced the severity of symptoms and shortened the duration of illness in patients by at least 2 days.
With Tinospora cordifolia treatment provided over a period of 8 weeks, 100% relief was reported from sneezing in 83% of patients, in 69% from nasal discharge, in 61% from nasal obstruction and in 71% from itchy nose. In the placebo group, there was no relief in 79% from sneezing, in 84.8% from nasal discharge, in 83% from nasal obstruction, and in 88% from itchy nose. The difference between the Tinospora cordifolia treatment group and the placebo groups was highly significant. Immune cells increased in 69% patients in drug treated group and in only 11% with placebo. After given Tinospora cordifolia, inflammatory effector cells were decreased and cells that secrete mucous were absent in nasal smear. After placebo, the decrease in inflammatory effector cell count was marginal and mucous producing cells were present. Tinospora cordifolia significantly decreased all symptoms of allergic rhinitis.
Upper Respiratory Tract Infections
Andrographis was found superior to placebo in 7 clinical trials for reducing subjective symptoms of URTIs, and it may also have a preventive effect.
In one clinical study, 158 patients with a common cold took 1200 mg of Andrographis per day for 5 days. Self-evaluations at day 2 showed reduced tiredness, sleeplessness, sore throat and nasal secretions. At day 4, they also experienced reduced earaches, phlegm, coughing and headaches.
In a recent study, 200 mg/day of KalmCold™, an extract of Andrographis, was measured in 223 URTI patients versus placebo. Both groups improved during days 1-3, but from days 3-5 the placebo group stopped improving or worsened while the treatment group improved in all symptoms except earache. The efficacy of Andrographis against placebo was 52.7% higher.
Another 5-day study administered 1020 mg of a 4% andrographolide extract to patients with a common cold. The patients treated with Andrographis took fewer sick leaves from work. 55% felt the course of the cold was easier than normal compared to placebo group (19%) and 68% felt totally recovered by the end of the 5 days, while only 36% of placebo group did.
A children’s study administered 200 mg of a 4% andrographolide extract to 107 school children for 3 months as a prophylaxis for the common cold. During the first two months there was no difference, but in month three, the Andrographis group experienced a 30% occurrence of the common cold compared to placebo group (62%).
In 152 adult patients experiencing pharyngotonsillitis, 6 g daily of Andrographis was as effective as paracetamol in improving symptoms (ie. sore throat and fever) after just 3 days of treatment.
Randomised, double-blind, placebo-controlled trial of EPs 7630 in adults with COPD.
Respir Med. 2013 May;107(5):691-701.
Matthys H, Pliskevich DA, Bondarchuk OM, Malek FA, Tribanek M, Kieser M.
BACKGROUND: Preventing and managing exacerbations is one major component in COPD treatment. We investigated whether EPs 7630, a herbal drug preparation from the roots of Pelargonium sidoides, could prolong time to acute exacerbation in patients with COPD stage II/III.
METHODS: In this randomised, double-blind, placebo-controlled clinical trial, patients were randomly allocated to oral 24-week add-on therapy with 3 × 30 drops/day EPs 7630 (n = 99) or placebo (n = 101) to a standardised baseline-treatment. Primary endpoint was time to first exacerbation of COPD. Secondary endpoints were number of exacerbations, consumption of antibiotics, quality of life, patient satisfaction, inability to work, and tolerability.
RESULTS: Median time to exacerbation was significantly prolonged with EPs 7630 compared to placebo (57 versus 43 days, Kaplan-Maier-estimate; p = 0.005, one-sided centre-stratified log-rank test). The superiority of EPs 7630 was also confirmed in secondary endpoints, e.g., fewer exacerbations, less patients with antibiotic use, improved quality of life, higher patient satisfaction, and less days of inability to work. The incidence of minor gastrointestinal adverse events was higher in the EPs 7630 group.
CONCLUSIONS: The results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use.
Can the Pelargonium sidoides root extract EPs® 7630 prevent asthma attacks during viral infections of the upper respiratory tract in children?
Phytomedicine. 2013 Jan 15;20(2):148-50.
Tahan F, Yaman M.
INTRODUCTION: Asthma is a chronic disease characterized by airway inflammation. Viral infection initiates an immune inflammatory response that may produce asthma attacks. There is no effective preventing therapy for asthma attack during upper respiratory tract viral infections.
OBJECTIVE: To investigate the efficacy of 5 days of Pelargonium sidoides therapy for preventing asthma attack during upper respiratory tract viral infections.
METHODS: Sixty one asthmatic children with upper respiratory tract viral infection were enrolled in the study. The patients were randomized to receive Pelargonium sidoides daily for 5 days (n=30) or not (n=31). Before and after treatment, they all were examined and symptom scores were determined. Following five days treatment, children were evaluated whether or not they had an asthma attack.
RESULTS: Treatment with Pelargonium sidoides was not associated with a statistically significant differences in fever and muscle aches (p>0.05, Chi-square test). There were significant differences in cough frequency and nasal congestion between the groups (p<0.05, Chi-square test). There were statistically significant differences in having asthma attack between the groups (p<0.05, Chi-square). Pelargonium sidoides group had less frequency of…
DISCUSSION: Our study shows that Pelargonium sidoides may prevent asthma attacks during upper respiratory tract viral infections.
Treatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescents.
Pediatr Int. 2012 Apr;54(2):219-26.
Kamin W, Ilyenko LI, Malek FA, Kieser M.
BACKGROUND: The aim of this trial was to investigate the efficacy and tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides, in children and adolescents suffering from acute bronchitis, outside the strict indication for antibiotics.
METHODS: A total of 220 patients with acute bronchitis were randomized and given either verum containing EPs 7630 (1-6 years/>6-12 years/>12-18 years: 3 × 10/3 × 20/3 × 30 drops/day) or matching placebo for 7 days. The main outcome measure was the change in the total score of bronchitis-specific symptoms (BSS) from day 0 to day 7.
RESULTS: The decrease in the BSS total score was significantly higher for EPs 7630 compared to placebo (change day 0-day 7: 4.4 ± 1.6 vs 2.9 ± 1.4 points; P < 0.0001). Improvements were most pronounced for ‘coughing’ and ‘rales at auscultation’. Tolerability was similarly good in both groups.
CONCLUSIONS: EPs 7630 proved to be an efficacious and well-tolerated option for the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics.
A randomized double blind placebo controlled clinical evaluation of extract of Andrographis paniculata (KalmCold) in patients with uncomplicated upper respiratory tract infection.
Phytomedicine. 2010 Mar;17(3-4):178-85.
Saxena RC, Singh R, Kumar P, Yadav SC, Negi MP, Saxena VS, Joshua AJ, Vijayabalaji V, Goudar KS, Venkateshwarlu K, Amit A.
A randomized, double blind placebo controlled clinical study was conducted to evaluate the efficacy of KalmCold, an extract of Andrographis paniculata, in patients with uncomplicated upper respiratory tract infection (URTI). The assessment involved quantification of symptom scores by Visual Analogue Scale. Nine self evaluated symptoms of cough, expectoration, nasal discharge, headache, fever, sore throat, earache, malaise/fatigue and sleep disturbance were scored. A total of 223 patients of both sexes were randomized in two groups which received either KalmCold (200 mg/day) or placebo in a double blind manner. In both the treatments, mean scores of all symptoms showed a decreasing trend from day 1 to day 3 but from day 3 to day 5 most of the symptoms in placebo treated group either remained unchanged (cough, headache and earache) or got aggravated (sore throat and sleep disturbance) whereas in KalmCold treated group all symptoms showed a decreasing trend. Within groups, mean scores of symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 all symptoms except expectoration in placebo group did not improve significantly whereas in KalmCold treated group all symptoms improved significantly (p < or = 0.05) except earache. Comparing mean between both groups, all symptoms at day 1 and day 3 were found to be the same while at day 5 all symptoms except earache in KalmCold treated group improved significantly (p < or = 0.05) than placebo group. Similarly, within groups, overall scores of all symptoms in both the groups decreased significantly (p < or = 0.05) from day 1 to day 3 and day 5 while from day 3 to day 5 placebo group did not improve significantly whereas KalmCold treated group showed significant improvement (p < or = 0.05). On between groups analysis, KalmCold group showed significant reduction (p < or = 0.05) in overall symptom scores as compared to placebo group. In both placebo and KalmCold treated groups, there were only a few minor adverse effects with no significant difference in occurrence (Z = 0.63; p > 0.05). The comparison of overall efficacy of KalmCold over placebo was found to be significant (p < or = 0.05) and it was 2.1 times (52.7%) higher than placebo. The findings of this study revealed that KalmCold was effective in reducing symptoms of upper respiratory tract infection.
Immune responses induced by Pelargonium sidoides extract in serum and nasal mucosa of athletes after exhaustive exercise: modulation of secretory IgA, IL-6 and IL-15.
Phytomedicine. 2011 Feb 15;18(4):303-8.
Luna LA Jr, Bachi AL, Novaes e Brito RR, Eid RG, Suguri VM, Oliveira PW, Gregorio LC, Vaisberg M.
The evidence that exhaustive exercise may compromise the immune response is mainly confirmed by upper respiratory tract infections which are probably related to the decrease in secretory immunoglobulin A in the upper airway mucosa and/or profile changes of systemic cytokines as well as local cytokines of the upper respiratory tract. An extract from Pelargonium sidoides roots is currently used to treat infections in the upper airways. The aim of the present study was to evaluate the action of this herbal medicine on the immune response of athletes submitted to an intense running session by analyzing the production of immunoglobulin A in their saliva and of cytokines both locally and systemically, using a placebo as control. The results show that Pelargonium sidoides extract modulates the production of secretory immunoglobulin A in saliva, both interleukin-15 and interleukin-6 in serum, and interleukin-15 in the nasal mucosa. Secretory immunoglobulin A levels were increased, while levels of IL-15 and IL-6 were decreased. Based on this evidence, we suggest that this herbal medicine can exert a strong modulating influence on the immune response associated with the upper airway mucosa in athletes submitted to intense physical activity.
Treatment of acute rhinosinusitis with the preparation from Pelargonium sidoides EPs 7630: a randomized, double-blind, placebo-controlled trial.
Rhinology. 2009 Mar;47(1):51-8.
Bachert C, Schapowal A, Funk P, Kieser M.
OBJECTIVE: To evaluate the efficacy and safety of the herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) compared to placebo.
DESIGN: Double-blind, randomized, placebo-controlled, parallel-group, multicenter trial with a group-sequential adaptive design.
SUBJECTS: Patients with sinonasal symptoms of at least 7 days duration, and radiographically and clinically confirmed acute rhinosinusitis of presumably bacterial origin with a Sinusitis Severity Score (SSS) of at least 12 out of 24 points at inclusion.
INTERVENTIONS: EPs 7630, a herbal drug preparation from the roots of Pelargonium sidoides (1: 8-10; extraction solvent: ethanol 11% (w/w)), or matching placebo at a dose of 60 drops three times daily for maximum 22 days.
MAIN OUTCOME MEASURES: Change in the SSS after 7 days.
RESULTS: 103 patients were recruited until the planned interim analysis. The mean decrease in the SSS was 5.5 points in the EPs 7630 group compared to 2.5 points in the placebo group, a difference of 3.0 points (95% confidence interval 2.0 to 3.9, p < 0.00001). This result was confirmed by all secondary parameters indicating a more favourable course of the disease and a faster recovery in the EPs 7630 group. According to the pre-specified decision rule, the study was stopped after obtaining proof of efficacy for EPs 7630.
CONCLUSIONS: EPs 7630 was well tolerated and superior in efficacy compared to placebo in the treatment of acute rhinosinusitis of presumably bacterial origin.
Efficacy of a Pelargonium sidoides preparation in patients with the common cold: a randomized, double blind, placebo-controlled clinical trial.
Explore (NY). 2007 Nov-Dec;3(6):573-84.
Lizogub VG, Riley DS, Heger M.
BACKGROUND: The common cold is a viral infection with symptoms such as sneezing, sore throat, and running nose. It is one of the most prevalent illnesses in the world, and although commonly caused by rhinoviruses, antibiotics are often prescribed unnecessarily. Therefore, it is of utmost importance to evaluate alternative treatments such as herbal medications, whose efficacy and safety is proven by pharmacological and clinical studies.
OBJECTIVE: The aim of the present study was to evaluate the efficacy of a liquid herbal drug preparation from the roots of Pelargonium sidoides compared with placebo in adult patients with the common cold.
DESIGN: The study was designed as a multicenter, prospective, randomized, double blind, parallel group, placebo-controlled phase III clinical trial with an adaptive group-sequential design.
SETTING: The study took place in eight outpatient departments affiliated with hospitals.
PATIENTS: One hundred three male and female adult patients with at least two major and one minor or with one major and three minor cold symptoms (maximum symptom score of 40 points), present for 24 to 48 hours, and who gave provision of informed consent were randomized to receive either 30 drops (1.5 mL) of the liquid herbal drug preparation EPs or placebo three times a day.
INTERVENTION: Patients received randomized treatment for a maximum period of 10 days.
MEASUREMENTS: The primary outcome criterion was the sum of symptom intensity differences (SSID) of the cold intensity score (CIS) from day one to day five. The CIS consists of the following 10 cold symptoms: nasal drainage, sore throat, nasal congestion, sneezing, scratchy throat, hoarseness, cough, headache, muscle aches, and fever.
RESULTS: From baseline to day five, the mean SSID improved by 14.6 /- 5.3 points in the EPs group compared with 7.6 /- 7.5 points in the placebo group. This difference was statistically significant (P < .0001). The mean CIS decreased by 10.4 /- 3.0 points and 5.6 /- 4.3 points in EPs and placebo-treated patients, respectively. After 10 days, 78.8% versus 31.4% in the EPs versus placebo group were clinically cured (CIS equals zero points or complete resolution of all but a maximum of one cold symptom; P < .0001). The mean duration of inability to work was significantly lower in the EPs treatment group (6.9 /- 1.8 days) than in the placebo group (8.2 /- 2.1 days; P = .0003). Treatment outcome (rates of complete recovery or major improvement from disease [integrative medicine outcomes scale]) was assessed better in the EPs treatment group than in the placebo group by both the investigator and the patient on day five (P < .0001). Adverse events occurred in three of 103 patients (2.9%), with two of 52 (3.8%) and one of 51 (2.0%) patients in the EPs and placebo group, respectively. All adverse events were assessed as nonserious. At the end of treatment, all patients (100%) in the active treatment group judged the subjective tolerability of EPs as good or very good.
CONCLUSIONS: EPs represents an effective treatment of the common cold. It significantly reduces the severity of symptoms and shortens the duration of the common cold compared with placebo. The herbal drug is well tolerated.
Efficacy of Tinospora cordifolia in allergic rhinitis.
J Ethnopharmacol. 2005 Jan 15;96(3):445-9.
Badar VA, Thawani VR, Wakode PT, Shrivastava MP, Gharpure KJ, Hingorani LL, Khiyani RM.
The efficacy of Tinospora cordifolia (TC) extract in patients of allergic rhinitis was assessed in a randomized double blind placebo controlled trial. Seventy-five patients were randomly given either TC or placebo for 8 weeks. They were clinically examined and Hb %, TLC, DLC and nasal smear was done. At the end of trial baseline investigations were repeated, drug decoded and results analyzed. With TC treatment 100% relief was reported from sneezing in 83% patients, in 69% from nasal discharge, in 61% from nasal obstruction and in 71% from nasal pruritus. In placebo group, there was no relief in 79% from sneezing, in 84.8% from nasal discharge, in 83% from nasal obstruction, and in 88% from nasal pruritus. The difference between TC and placebo groups was highly significant. TLC increased in 69% patients in drug treated group and in only 11% with placebo. After TC, eosinophil and neutrophil count decreased and goblet cells were absent in nasal smear. After placebo, decrease in eosinophil and neutrophil count was marginal and goblet cells were present. TC significantly decreased all symptoms of allergic rhinitis. Nasal smear cytology and leukocyte count correlated with clinical findings. TC was well tolerated.
Andrographis paniculata in the treatment of upper respiratory tract infections: a systematic review of safety and efficacy.
Planta Med. 2004 Apr;70(4):293-8.
Coon JT, Ernst E.
Acute respiratory infections represent a significant cause of over-prescription of antibiotics and are one of the major reasons for absence from work. The leaves of Andrographis paniculata (Burm. f.) Wall ex Nees (Acanthaceae) are used as a medicinal herb in the treatment of infectious diseases. Systematic literature searches were conducted in six computerised databases and the reference lists of all papers located were checked for further relevant publications. Information was also requested from manufacturers, the spontaneous reporting schemes of the World Health Organisation and national drug safety bodies. No language restrictions were imposed. Seven double-blind, controlled trials (n = 896) met the inclusion criteria for evaluation of efficacy. All trials scored at least three, out of a maximum of five, for methodological quality on the Jadad scale. Collectively, the data suggest that A. paniculata is superior to placebo in alleviating the subjective symptoms of uncomplicated upper respiratory tract infection. There is also preliminary evidence of a preventative effect. Adverse events reported following administration of A. paniculata were generally mild and infrequent. There were few spontaneous reports of adverse events. A. paniculata may be a safe and efficacious treatment for the relief of symptoms of uncomplicated upper respiratory tract infection; more research is warranted.
Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trial.
Altern Ther Health Med. 2003 Sep-Oct;9(5):68-79.
Bereznoy VV, Riley DS, Wassmer G, Heger M.
BACKGROUND: Clinical trial data suggest that antibiotics are not indicated for the treatment of acute non-group A beta hemolytic strep (non-GABHS) tonsillopharyngitis. Nevertheless patients are symptomatic and effective alternatives for its treatment are needed that have been evaluated in clinical trials.
OBJECTIVE: To confirm that treatment with an extract of Pelargonium sidoides (EPs 7630) is superior to placebo for the treatment of non-GABHS tonsillopharyngitis in children.
DESIGN: Randomized, double-blind, placebo-controlled trial.
SETTING: Six study sites in 4 pediatric and ENT primary care outpatient clinics.
PATIENTS: One hundred forty-three children aged 6-10 years with non-GABHS tonsillopharyngitis present < or = 48 h, a negative rapid strep screen, a Tonsillopharyngitis Severity Score (TSS) > or = 8 points, and informed consent.
INTERVENTION: EPs 7630 or placebo (20 drops tid) for 6 days.
MEASUREMENT: The primary outcome criterion was the decrease of the TSS from baseline (day 0) to day 4.
RESULTS: The decrease of the TSS from baseline (day 0) to day 4 was 7.1 /- 2.1 points under EPs 7630 (n = 73), and 2.5 /- 3.6 points under placebo (n = 70). The covariate adjusted decrease was 7.0 /- 2.4 points under EPs 7630, and 2.9 /- 2.4 points under placebo. The 95% RCI for the difference between the groups was [2.7; 4.9] demonstrating a significant difference in efficacy of EPs 7630 compared to placebo (P < 0.0001). Adverse events (AEs) occurred in 15/143 patients (EPs 7630: 4/73
patient, placebo: 44/70) and were not related to the investigational medication.
CONCLUSIONS: EPs 7630 was superior compared to placebo for the treatment of acute non-GABHS tonsillopharyngitis in children. Treatment with EPs 7630 reduced the severity of symptoms and shortened the duration of illness by at least 2 days.