A clinical study to see the effect of some Ayurvedic formulation in the management of Lipid Disorders.

Phase 2

Recruiting

• Conditions: Dyslipidemia

• Registration Number: CTRI/2012/03/002528
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of India. CCRAS is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine.

Aimed at generating evidence for the scientific validation of the clinical efficacy and safety of twenty five classical Ayurvedic formulations, multicentre clinical trials have been initiated in sixteen disease areas across nineteen peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program.

This initiative is basically a supplement to the similar venture being worked out as an activity under the Ayurveda Clinical Trials (A.C.T.) project of the Ayurvedic Pharmacopoeia Committee (APC) wherein, clinical trials on eighteen disease conditions are underway in eight post graduate Ayurveda colleges across the country.

**Vyoshadi Guggulu** is a poly herbal preparation 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 Harada (Terminalia chebula).

The present study entitled **“Clinical Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Dyslipidemiaâ€** is being undertaken in three peripheral institutes of the CCRAS. A similar study has been registered **(Reg No CTRI/2012/01/002374)** in the Clinical Trials Registry, India (CTRI) as an activity under the ACT project.

The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-08
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 1. Patients having LDLc 100mg/dL.
• 160mg/dL and / or Serum cholesterol 200mg/dL.
• 250mg/dL and / or Serum Triglycerides –150mg/dL.
• 250 mg/dL 2. Willing and able to participate in the study for 16 weeks.

Exclusion Criteria

• Patients who have received any cholesterol lowering medication (Modern Drug) within last 8 weeks.
• Patients having Type III and Type IV hypercholesterolaemia 3.
• Patients with evidence of malignancy 5.
• Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, immunosuppressants, estrogen replacement therapy 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.) 7.
• 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 aminotransferase (AST) and / or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) > 2 times upper normal limit) or renal disorders (defined as S.creatinine >1.2mg/dL), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel disease or any other condition that may jeopardize the study..
• Pregnant/ lactating females.
• Patients on oral contraceptives.
• Alcoholics and/or drug abusers.
• H/o hypersensitivity to any of the trial drugs or their ingredients.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Lipid Profile	At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 14th week.

Secondary Outcome Measures

Name	Time	Method
Change in the Quality of Life (SF-36 Health Survey) Score	At Baseline, 84th day and at the end of follow up after 14th week

Trial Locations

Locations (3)

National Ayurveda Research Institute for Vector Borne Diseases (NARIVBD), Vijayawada; 🇮🇳 Krishna, ANDHRA PRADESH, India

National Institute of Ayurveda Pharmaceutical Research (NIAPR), Patiala; 🇮🇳 Patiala, PUNJAB, India

National Research Institute for Panchakarma (NRIP), Cheruthuruthy; 🇮🇳 Thrissur, KERALA, India

National Ayurveda Research Institute for Vector Borne Diseases (NARIVBD), Vijayawada

🇮🇳Krishna, ANDHRA PRADESH, India

Dr V Subhose

Principal investigator

9490424439

dr_vsubhose@yahoo.com