Clinical Evaluation of Vyaghri Haritaki in the Management of Chronic Bronchitis.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Change in the clinical symptoms of chronic bronchitis viz: Productive cough, Dyspnoea, Wheezing, Chest pain, Sore throat and Nasal congestion.
Study Overview
Brief Summary
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D. / PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.
Vyaghri Haritaki, a polyherbal Ayurvedic formulation containing Kantakari (Soalnum surratense), Haritaki (Terminalia chebula), Shunthi (Zingiber officinale), Maricha (Piper nigrum), Pippali (Piper longum), Tvaka (Cinnamomum zeylanicum), Patra (Cinnamomum tamala), Ela (Elettaria cardamomum), Nagkesara (Mesua ferrea), Jaggery and Honey has been in use since ages, and has been found to be useful in treating Chronic Bronchitis and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of this Ayurvedic formulation as a part of their Post Graduate (PG) Thesis.
The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.
The present study is being undertaken to scientifically study and validate the clinical efficacy and safety of Vyaghri Haritaki- a classical Ayurvedic formulation. This formulation has been in use since ages, and has been found to be useful in treating Chronic Bronchitis and promoting the health.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 16.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients of either sex aged between 16 to 70 years.
- •2.Patients with history of uncomplicated Chronic Bronchitis.
- •(Chronic Bronchitis is defined as a cough that occurs every day with sputum production that lasts for at least three months, two years in a row).
- •3.Patient willing and able to participate in the study for 16 weeks.
Exclusion Criteria
- •1.Patients suffering from Acute Bronchitis.
- •2.Patients having PEFR < 50% of the predicted value.
- •3.Presence of other pulmonary diseases like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.
- •4.Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 5.Patients with poorly controlled Hypertension ( ≥160 / 100 mm Hg) 6.Patients on prolonged (> 6 weeks) medication with corticosteroids, bronchodilators, Mast cell stabilizers, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •7.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 8.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •9.Symptomatic patients with clinical evidence of Heart failure.
- •10.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine >1.2mg/dL).
- •11.Smokers/alcoholics and/or drug abusers.
- •12.H/o hypersensitivity to the trial drug or any of its ingredients.
- •13.Patients who have completed participation in any other clinical trial during the past six (06) months.
- •14.Pregnant or lactating women.
- •15.Any other condition which the Principal Investigator thinks may jeopardize the study.
Outcomes
Primary Outcomes
Change in the clinical symptoms of chronic bronchitis viz: Productive cough, Dyspnoea, Wheezing, Chest pain, Sore throat and Nasal congestion.
Time Frame: Baseline-14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up of 4 weeks
Secondary Outcomes
- •Change in St. George’s Respiratory Questionnaire (SGRQ) scores(Baseline-14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up of 4 weeks)