Clinical Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Obesity (Sthaulya)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- · Change in BMI
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.
Vyoshadi Guggulu is a poly herbal formulation containing Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Citraka (Plumbago zeylanica), Musta (Cyperus rotundus), Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Vidanga (Embelia ribes) and Guggulu (Commiphora wightii).
Haritaki Churna consists of dried pericarp of mature fruits of Terminalia chebula.
Vyoshadi Guggulu and Haritaki Churna have been in use since ages and found to be useful in treating Obesity (Sthaulya) 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 these Ayurvedic formulations 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.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex with age between 18 and 65 years.
- •BMI ≥30 kg/m2 and < 40 kg/m2
- •Willing and able to participate in the study for 16 weeks.
Exclusion Criteria
- •Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months.
- •Pathophysiologic/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader willi syndrome).
- •Patients with evidence of malignancy
- •Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
- •Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
- •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •Symptomatic patient with clinical evidence of Heart failure.
- •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), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
- •Alcoholics and/or drug abusers.
- •Prior surgical therapy for obesity
- •H/o hypersensitivity to any of the trial drugs or their ingredients.
- •Pregnant / lactating woman.
- •Patients who have completed participation in any other clinical trial during the past six (06) months.
- •Any other condition which the Principal Investigator thinks may jeopardize the study.
Outcomes
Primary Outcomes
· Change in BMI
Time Frame: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.
Secondary Outcomes
- · Change in waist circumference and waist: hip ratio.(· Change in Lipid Profile.)