| CTRI Number |
CTRI/2016/07/007067 [Registered on: 11/07/2016] Trial Registered Retrospectively |
| Last Modified On: |
09/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Tab HFO-O2 in fatty individuals. |
|
Scientific Title of Study
|
Clinical study to evaluate the safety and efficacy of Herbal formulation for Obesity [HFO-O2] in overweight individuals |
| 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 |
| Address |
Interactive Research School for Health Affairs, Bharati Vidyapeeth Deemed University,Dhankawadi, Pune- Satara Road, Pune
Interactive Research School for Health Affairs, Bharati Vidyapeeth Deemed University,Dhankawadi, Pune- Satara Road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
020-24373954 |
| 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 |
| Address |
Interactive Research School for Health Affairs, Bharati Vidyapeeth Deemed University,Dhankawadi, Pune- Satara Road, Pune
Interactive Research School for Health Affairs, Bharati Vidyapeeth Deemed University,Dhankawadi, Pune- Satara Road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
020-24373954 |
| 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 |
| Address |
Interactive Research School for Health Affairs, Bharati Vidyapeeth Deemed University,Dhankawadi, Pune- Satara Road, Pune
Interactive Research School for Health Affairs, Bharati Vidyapeeth Deemed University,Dhankawadi, Pune- Satara Road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
020-24373954 |
| Fax |
|
| Email |
supriya.bhalerao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baidyanath Bhawan Pvt. Ltd.,Great Nag Road, Nagpur, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Baidyanath Bhavan Pvt Ltd |
| Address |
Shree Baidyanath Ayurved Bhavan, Great Nag Road, Nagpur-09 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
College of Ayurved, BVDU |
Bharati Hospital, Department of Kayachikitsa, Room No. 4,Dhankawadi, Pune-Satara Road, Pune-411043
Pune
MAHARASHTRA |
9527589516
supriya.bhalerao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDU College of Ayurved, Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human volunteers with a BMI between 25 and 30 are to be recruited |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HFO-O2(Herbal Formulation for Obesity) |
A combination of Triphala(150mg), Trimad(150mg),Guggul(50mg) and Vrukshamla(250mg) to be administered orally, 2 tablets twice a day for a period of 3 months. |
| Comparator Agent |
Not Applicable |
- |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Overweight individuals (Body Mass Index between 25-30) 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 between 18 years and 60 years
4.Individuals found compliant based on the Million Behavioural Medicine Diagnostic (MBMD)
5.Willing to give Informed consent before any trial-related activity takes place
|
|
| ExclusionCriteria |
| Details |
1.Known case of endocrinological disorders such as hyper/hypo thyroidism, Poly Cystic Ovarian Syndrome (PCOS)
2.History of use one month before screening /currently using Allopathic or Ayurvedic medicines that may cause significant weight gain
3.History of use one month before screening /currently using dietary supplements, over-the-counter medications or below mentioned Allopathic /Ayurvedic medicines for weight loss
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 [judged by frequency and quantity of food]
6.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator
7.Pregnant or lactating females
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study will be measured in terms of anthropometric measurements (Weight, Body Mass Index, Waist Hip Ratio, Circumferences, Skinfold thicknesses)and Clinical signs and symptoms. |
After every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study will be measured on the basis of biochemical profiling of obesity markers. |
Day 0,Day 30,Day 60,Day 90, Day 120 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/02/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the study is to evaluate the clinical efficacy of Tab. HFO-O2 in overweight individuals. |