| 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) |
|
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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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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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 |
|
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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
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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 |
|
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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)?
|
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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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