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CTRI Number  CTRI/2017/11/010409 [Registered on: 07/11/2017] Trial Registered Retrospectively
Last Modified On: 07/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Safety and efficacy study of Triphala and Trimad in obseity 
Scientific Title of Study   Evaluation of the safety and efficacy of Triphala and Trimad in Obese and overweight individuals: A pilot clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Supriya Bhalerao 
Designation  Scientist 
Affiliation  Interactive Research School for Health Affairs (IRSHA) 
Address  Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth Deemed University Dhankawadi, Pune-Satara Road, Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  91-9527589516  
Fax    
Email  supriya.bhalerao@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Supriya Bhalerao 
Designation  Scientist 
Affiliation  Interactive Research School for Health Affairs (IRSHA) 
Address  Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth Deemed University Dhankawadi, Pune-Satara Road, Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  91-9527589516  
Fax    
Email  supriya.bhalerao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Supriya Bhalerao 
Designation  Scientist 
Affiliation  Interactive Research School for Health Affairs (IRSHA) 
Address  Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth Deemed University Dhankawadi, Pune-Satara Road, Pune 411043

Pune
MAHARASHTRA
411043
India 
Phone  91-9527589516  
Fax    
Email  supriya.bhalerao@gmail.com  
 
Source of Monetary or Material Support  
As the study is investigator initiated and hence the PI and the instituition is primary sponsor. The Drug used in the study were provided by Pharmanza Herbal Pvt. Ltd.,Plot # 214,Borsad-tarapur,Nr. Vadala patiya,At:KANIYA-388435,Ta:petlad,Dist:Anand, Gujarat (INDIA) 
 
Primary Sponsor  
Name  Interactive Research school for health Affairs 
Address  Interactive Research school for health Affairs, Bharati Vidyapeeth Deemed University, Pune- 411043 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Supriya Bhalerao  Vishwanand Kendra  101 Pramod Vihar, Off Pune Satara Road, Pune Satara Road, Pune - 411009, Walvekar Nagar
Pune
MAHARASHTRA 
91-9527589516

supriya.bhalerao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
centre for intergrative medicine and research Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Obesity 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Triphala, Trimad and Placebo  triphala, trimad and placebo (randomly) Overweight (BMI ≥ 25kg/m2)–2 tablets (500mg each) two times in a day Obese (BMI ≥ 30kg/m2)–2 tablets (500mg each) three times in a day  
Comparator Agent  Triphala, Trimad and placebo  triphala, trimad and placebo (randomly) Overweight (BMI ≥ 25kg/m2)–2 tablets (500mg each) two times in a day Obese (BMI ≥ 30kg/m2)–2 tablets (500mg each) three times in a day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Obesity (BMI ≥30.0 kg/m2); or overweight (BMI ≥25.0 kg/m2) with controlled co-morbid dyslipidemia and/or hypertension and/or type 1 or type 2 diabetes
2. Stable body weight (less than 5 kg self-reported change during the previous 3 months)
3. Age ≥18 years to ≤60 years
4. Willing to give Informed consent before any trial-related activity takes place
 
 
ExclusionCriteria 
Details  1. Known case of any other endocrinological disorders
2. Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including
o Allopathic medicines: systemic corticosteroids (except for a short course of treatment, i.e. 7−10 days),tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium)
o Ayurvedic medicines: Shatavari, Ashwagandha, Bala etc.
3. History of use/ currently using dietary supplements, over-the-counter medications or below mentioned Allopathic /Ayurvedic medicines one month before screening
o Allopathic medicines: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, or metformin (either by prescription or as part of a clinical trial)
o Ayurvedic medicines: Guggulu, Trikatu, Triphala, Trimada, Shilajatu and/ or any other ayurvedic medicine (causing weight reduction) either individually or as a part of any other formulation
4. Current participation (past one month) in an organized weight reduction program
5. Participants with a history of major depressive or other severe psychiatric disorders or an eating disorder
6. Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator
7. Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
weight loss  every fifteen day from day of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
body fat monitor parameters, inches loss  every fifteen day from day of recruitment 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/02/2016 
Date of Study Completion (India) 17/12/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction and purpose of the study:

Obesity is a medical condition which occurs due to excess storage of fat. In recent times it has become common problem in all age groups. Diet and exercise are the primary way of obesity prevention but with short term benefits. Conventional drugs cause various side effects and expensive too. Obesity control is important to avoid other complications like cardiovascular disorder, hypertension, GI disorder etc. In case of very high weight, surgery is recommended but it is painful is not cost effective.

 

Triphala and Trimad are Ayurvedic herbal formulations known for their beneficial effects mentioned in Ayurveda. Triphala is commonly used for various medical problems and multi-functional. Trimad is known for boosting immunity, stop fat deposition and act as appetizer. Their efficacy in weight management has been proved in some modern research. Hence the present study has been planned to evaluate the safety and efficacy of Triphala and Trimad for obesity control and associated benefits to it.

 

Objectives of the Study:

i.         To evaluate the effect Triphala and Trimad on weight management in obese and overweight individuals

ii.       To evaluate the effect of Triphala and Trimad in body fat composition and inches loss

 

Duration of participation in the Study:  After obtaining informed consent from participate in the study, they have to visit study site Vishwanand kendra after every 15 days till the end of study for 120 days. We would take a written consent for the purpose.

 

Study Procedures and Methods:

After screening and categorizing participants as overweight and obese as per BMI drug will be dispensed.

During this meeting (Day 0), detail history with respect to present complaints and any other significant medical/surgical illnesses will be taken. Participant will undergo clinical examination to check for weight, height (once), circumference (waist, hip) to assess the BMI, WHR. Following this, a questionnaire will be administered to assess quality of life and eating behavior. Both Participant and  study physician will not be aware of the drug which patients will receive till the end of the treatment.

 

On every  15 days, participants will undergo clinical examination, like weight, height, and circumference and also administered questionnaire. They will be interrogated about change in your symptoms, and unwanted symptom/s developed after start of the therapy, if any.

 

All the investigations carried out on Day 0 will be repeated every 15 days of visit. The analysis of  samples will help in judging the improvement in weight reduction after taking Triphala or Trimad and placebo effect.

Results and outcome:

The parameters evaluated were anthropometric profile (weight, Body Mass Index, circumferential measures viz. waist, hip, neck, mid-arm, mid-thigh) along with body composition analysis (Fat%, visceral fat %, muscle mass, resting metabolism, body age). The formulations have showed improvement in all the parameters significantly more than placebo. Interestingly, the patients treated with formulation showed minimal weight gain after stopping the treatment.


 
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