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CTRI Number  CTRI/2012/01/002377 [Registered on: 25/01/2012] Trial Registered Retrospectively
Last Modified On: 17/01/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to see the effect of some Ayurvedic formulations in the management of Obesity 
Scientific Title of Study   Clinical Evaluation of Vyoshadi Guggulu and Haritaki Churna in the Management of Obesity (Sthaulya) 
Trial Acronym  ACT- OB-2010 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri -110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri -110058
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri -110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri -110058
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Dua 
Designation  Research Officer (co-ordinator ACT project) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri -110058
Central Council for Research in Ayurvedic Sciences (CCRAS), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block, Janakpuri -110058
West
DELHI
110058
India 
Phone  011-28525831  
Fax  011-28520748  
Email  duadrpradeep@gmail.com  
 
Source of Monetary or Material Support  
Support in terms of infrastructural facilities: 1. National Institute of Ayurveda (NIA), Jaipur. 2. Tilak Ayurved Mahavidyalaya, Pune. 3. Vaidyaratnam P. S. Varier Ayurved College, Kottakkal. 
 
Primary Sponsor  
Name  Department of AYUSH Ministry of Health Family Welfare Government of India  
Address  Department of AYUSH, Ministry of Health & Family Welfare, Government of India, IRCS Building, Red Cross Road, New Delhi-110001 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Narainsingh Chundawat Dr Pankaj  National Institute of Ayurveda (NIA), Jaipur   Department of Swasthavrutta, Amer Road, Madhav Vilas Palace, Jaipur-302002
Jaipur
RAJASTHAN 		 9461624248
0141-2635709
nschundawat.nia@gmail.com 
Dr S V Deshpande Dr Mrinmayi Baviskar  Tilak Ayurved Mahavidyalaya, Pune  Department of Kayachikitsa,TAMV, 583/2, Rasta Peth, Pune-411011
Pune
MAHARASHTRA 		 9960071113
020-26336428
drsvdeshpande@yahoo.com 
Dr KV Dilipkumar Dr Deepti Nair   Vaidyaratnam P. S. Varier Ayurved College, Kottakkal  Department of Swasthavrutta, Kottakkal, P.O. Edarikode, Mallapuram-676501
Malappuram
KERALA 		 9847093321
0483-2751851
drdilipkv@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda (NIA), Jaipur  Approved 
Institutional Ethics Committee, Tilak Ayurved Mahavidyalaya, Pune  Approved 
Institutional Ethics Committee, VPSV Ayurved College, Kottakkal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Obesity (Sthaulya),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Haritaki Churna  Dose – 3 gm twice daily Dosage form – Sachet of 3 gm each Route of Administration – Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form-Plastic jar containing 30 sachets Duration of therapy-12 weeks 
Comparator Agent  Not applicable  Not applicable 
Intervention  Vyoshadi Guggulu  Dose – 1.5 gm (3 Tablets)twice daily Dosage form - Tablet of 500 mg Route of Administration – oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form- Bottle containg 60 tablets Duration of therapy-12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex with age between 18 and 65 years.
2. BMI ≥30 kg/m2 and < 40 kg/m2
3. Willing and able to participate in the study for 16 weeks. 
 
ExclusionCriteria 
Details  1. Intake of over the counter weight loss agents, centrally acting appetite suppressants in
the previous six months.
2. Pathophysiologic/ genetic syndromes associated with obesity (Cushing’s syndrome,
Turner’s syndrome, Prader willi syndrome).
3. Patients with evidence of malignancy
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 corticosteoids, 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 patient 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), Severe Pulmonary Dysfunction (uncontrolled
Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any
other condition that may jeopardize the study.
11. Alcoholics and/or drug abusers.
12. Prior surgical therapy for obesity
13. H/o hypersensitivity to any of the trial drugs or their ingredients.
14. Pregnant / lactating woman.
15. Patients who have completed participation in any other clinical trial during the past
six (06) months.
16. Any other condition which the Principal Investigator thinks may jeopardize the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
· Change in BMI  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 Outcome  
Outcome  TimePoints 
· Change in waist circumference and waist: hip ratio.
· Change in Lipid Profile.
· Change in quality of life – SF-36 Scale 		 Waist:Hip ratio is done At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end offollow up after 16th week.
Lipid Profile is done Before and After treatment only wheres as, SF-36 is done at Baseline, at 84th day and after follow up of 16 weeks.  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   08/01/2011 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   To be published after the completion of the clinical trials in all the three centers. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 
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