| CTRI Number |
CTRI/2015/11/006333 [Registered on: 02/11/2015] Trial Registered Prospectively |
| Last Modified On: |
30/10/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF DIET THERAPY AND VYOSHADI SAKTU IN REDUCING OBESITY- A COMPARATIVE STUDY |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE ROLE OF DIET THERAPY AND VYOSHADI SAKTU IN OBESITY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Katti |
| Designation |
Lecturer |
| Affiliation |
Govt. Ayurveda Medical college, |
| Address |
Department of Ayurveda siddhanta,
Govt. Ayurveda Medical college,
New Sayyaji rao road,
Mysore
New Sayyaji rao road,
Mysore-570021
Mysore
KARNATAKA
570021
India |
| Phone |
9886028646 |
| Fax |
0821-2443701 |
| Email |
ayurvedananda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Katti |
| Designation |
Lecturer |
| Affiliation |
Govt. Ayurveda Medical college, |
| Address |
Department of Ayurveda siddhanta,
Govt. Ayurveda Medical college,
New Sayyaji rao road,
Mysore
New Sayyaji rao road,
Mysore-570011
Mysore
KARNATAKA
570021
India |
| Phone |
9886028646 |
| Fax |
0821-2443701 |
| Email |
ayurvedananda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Katti |
| Designation |
Lecturer |
| Affiliation |
Govt. Ayurveda Medical college, |
| Address |
Department of Ayurveda siddhanta,
Govt. Ayurveda Medical college,
New Sayyaji rao road,
Mysore
New Sayyaji rao road,
Mysore-570021
Mysore
KARNATAKA
570021
India |
| Phone |
9886028646 |
| Fax |
0821-2443701 |
| Email |
ayurvedananda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pricipal,
Govt Ayurveda Medical college,
New Sayyaji Rao Road
Mysore-570021 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda Medical college Mysore |
| Address |
New Sayyaji rao road,
Mysore |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand Katti |
Govt. Ayurveda Medical College, ysore |
Department of Ayurveda siddhanta,New Sayyaji rao road, Mysore
Mysore
KARNATAKA |
9886028646
0821-2443701
ayurvedananda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee govt ayurveda medical college mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Obese, Non DM, Non HTN, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diet Therapy |
Diet of the patient is regulated |
| Intervention |
Vyoshdi sakthu |
its an Drug Forulation is in the Use in ayurveda for managing Obesity. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
• Elevated levels of lipid profile
• BMI between >30 to 40kg/m2
• Willing to come for regular follow-up visits
• Able to give written information consent
|
|
| ExclusionCriteria |
| Details |
• Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months
• Pathophysiological/ 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 with poorly controlled Hypertension (>160/100 mm Hg)
• Patients on prolonged (> 6 weeks) medication with corticosteroids, 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 Infraction, 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) > 2.5 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.
.
• History of HIV and other viral infections
• Alcoholics and/or drug abusers
• Prior surgical therapy for obesity
• History of hypersensitivity to any of the herbal extracts or dietary supplements.
• Pregnant/ lactating women.
• Patients who have completed participation in any other clinical trial during the past six (03) months.
• Any other condition which the principal investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease in body weight and body mass index
Decrease in waist circumference and waist hip ratio (anthropometric measurements)
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decrease in cholesterol, Triglycerides, LDL and VLDL values from baseline
Increase in HDL values from baseline
Increase in the levels of serum calcium and BMD
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/11/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, parallel group, single-centre trail comparing the efficacy of diet therapy and Vyoshadi saktu for 30 days in 60 patients with obesity that will be conducted in Govt. ayurveda Medical college, Mysore in India, The primary outcome measures will be Decrease in body weight and body mass index, Decrease in waist circumference and waist hip ratio (anthropometric measurements). The secondary outcomes will Decrease in cholesterol, Triglycerides, LDL and VLDL values from baseline Increase in HDL values from baseline Increase in the levels of serum calcium and BMD
|