| CTRI Number |
CTRI/2019/01/016879 [Registered on: 03/01/2019] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate effectiveness, safety and efficacy of obinil Tablet in treatment of Obesity |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Multicentre, Interventional, Prospective, Clinical Study to Evaluate Efficacy and Safety of Anti-Obesity Formula in Obese Subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Pranjal Nandode |
| Designation |
Project Manager |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office No. 318, level 3, Next to frankfinn, Connaught Place , Bund Garden Road, Pune Pune MAHARASHTRA 411001 India |
| Phone |
020-4860-3577 |
| Fax |
|
| Email |
pranjal@ardent-cro.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vinod Kuber |
| Designation |
Vice president |
| Affiliation |
SAVA Healthcare Ltd |
| Address |
2nd Floor, Lalwani Plaza, B-Wing, Sakore Nagar, Co-Operative Society, Off New Airport Road, Viman Nagar, Pune, Maharashtra 411014 Pune MAHARASHTRA 411014 India |
| Phone |
02030516100 |
| Fax |
|
| Email |
vinod.kuber@savaglobal.com |
|
Details of Contact Person Public Query
|
| Name |
Mr Chandu Devanpally |
| Designation |
Managing Director |
| Affiliation |
Ardent Clinical Research Services |
| Address |
Office No. 318, level 3, Next to frankfinn, Connaught Place, Bund Garden Road, Pune Pune MAHARASHTRA 411001 India |
| Phone |
020-4860-3577 |
| Fax |
|
| Email |
cdevanpally@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAVA Healthcare Ltd,
2nd Floor, Lalwani Plaza, B-Wing, Sakore Nagar, Co-Operative Society, Off New Airport Road, Viman Nagar, Pune, Maharashtra 411014 |
|
|
Primary Sponsor
|
| Name |
SAVA Healthcare Ltd |
| Address |
2nd Floor, Lalwani Plaza, B-Wing, Sakore Nagar, Co-Operative Society, Off New Airport Road, Viman Nagar, Pune, Maharashtra 411014 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aman Khanna |
Aman Hospital and Research Centre |
Aman Hospital and Research Centre,
15, Shashwat, Opp. ESI Hospital, Sarabhai,
Gotri Road, Vadodara – 390021, Gujarat, India
Vadodara GUJARAT |
9904402122
amankhanna1974@gmail.com |
| Dr Rahul Mahajan |
Ashwin Medical foundations Moraya Mltispeciality hospital |
Chinchwadgaon , Pune- 411033 Pune MAHARASHTRA |
9822177957
rahulsm87@yahoo.co.in |
| Dr Aparna Kodre |
Noble hospital Pvt. Ltd |
153, Magarpatta City Road, Hadapsar, Pune Pune MAHARASHTRA |
9850136436
draparnakodre@gmail.com |
| Dr Mukesh Mishra |
Shat Aayu Multispeciality hosptal |
Wardha Road, Nagpur Nagpur MAHARASHTRA |
9822565161
shatayuhospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| institutional Ethics Committee AMan Hospital and Research Centre |
Approved |
| Jasleen hospitals ethics committee |
Approved |
| Moraya Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z682||Body mass index (BMI) 20-29, adult, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Obinil |
Obinil or Placebo are tablets with multiple ingredients. Treatment will be allocated as per randomization code list. Eligible subjects have to consume two tablets of obinil or placebo twice daily, orally, after meals for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male &/ Or female volunteers aged between 18 to 65 years both inclusive. 2. BMI greater than or equal to 25 kg/m2 and less than or equal to 34.9 Kg/m2. 3. willing to exercise for a span of 30 min daily for at lease 5 days in a week.4. willing to follow diet advised by investigator. 5. willing to come for regular follow up visits. |
|
| ExclusionCriteria |
| Details |
Intake of over the counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months.
2. History of pathophysiologic/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Parder-Willi syndrome).
3. Alcoholics and subjects with substance abuse.
4. Subjects with evidence of malignancy.
5. Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, rheumatoid arthritis.
6. Subjects having history of coagulopathies, cardiovascular diseases, Asthma.
7. Subjects with HbAlc> 7% and poorly controlled diabetes mellitus, poorly controlled hypertension.
8. TSH > 10mIU/L and T3 and T4 higher than normal range.
9. Pregnant and lactating women.
10. Subjects with hepatic and renal failure.
11. Subjects 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.
12. Subjects with hypersensitivity to any one ingredient of the drugs.
13. Subjects who have participated in other trial within last 3 months.
14. Any other condition which the principal investigator thinks may jeopardize the study. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Anti-obesity Formulated Tab Obinil in obese subjects by assessing |
Change in body weight over the period of 90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Anti-obesity Formulated Tab Obinil in obese subjects by assessing |
Change in body weight (kg) over a period of 3 months of treatment between the groups.
2. Change in anthropometric measurements (waist circumference, hip circumference, waist: hip ratio, body fat percentage, basal metabolic rate (BMR), total body water (TBW), lean body mass (LBM), neck circumference, upper mid arm circumference, calf circumference) between the groups.
3. Change in serum leptin level between the groups.
4. Change in lipid profile between the groups. |
|
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Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
09/01/2019 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Obesity is a condition in which a person has excess body fat. More than just a number on a scale or the size of someone’s body, obesity can increase a person’s risk of diseases and health problems, including high blood pressure, diabetes and heart disease. It is a complex problem and major public health concerns. Obesity is usually defines using a ratio of height to weight called body mass index (BMI), which often correlates with the person’s level of body fat. According to the CDC BMI of 30.0 Kg/m2 or higher is considered as obese.
Currently, plant-based natural products as anti-obesity therapeutics are largely unexplored. Many plant-derived molecules have been found to possess anti-obesity effects with advantages over chemical treatments. So there is a basic need to develop effective drugs for obesity management/treatment with minimal side effects. Plants may prove promising options for the same.Natural plant products are widely used in healthcare or as dietary supplements. The important phytomolecules include flavonoids, terpenoids, saponins, phenols and alkaloids. The majority of plant extracts are not single compounds but rather a mixture of different molecules; therefore their mechanism of action usually targets several organ and cellular systems. The phytomolecules would act through their inhibitory activities for pancreatic lipases, adipocyte differentiation or by increasing thermogenesis and anorexia. In this review, we discuss the anti-obesity potential of phytomolecules and also analyze their mechanisms for treating obesity.
STUDY RATIONALE
Obinil Tab:
Obinil Tab is a unique combination of several nutritional supplements, which decreases the cholesterol level and also blood pressure. It works by preventing some of the fat in foods eaten from being absorbed in the intestines. This unabsorbed fat is then removed from the body in the stool. Total of 120 subjects will be enrolled in the study and randomized into two groups, one group receiving Obinil tablets as a dietary supplements and other group receiving placebo [2 tablets twice a day after meals]. The individual subject participation will be for 90 days, additional 15 days for follow up. Safety End Points: Laboratory investigations will be performed to check abnormal lab parameters. Lab investigations will include; a) CBC b) Biochemistry c) Urine examination All adverse events (AEs) and SAE will be recorded at each visit to assess safety of the IP. Systemic Examinations: Physical examination (performed on all visits i.e., screening and all follow-up visits) Pulse rate, Respiratory rate, temperature, systolic and diastolic blood pressure Systemic examinations will be performed on all the visits and the clinical abnormality shall be noted in CRF. The quality of life questionnaires will be checked and body mass index, anthropometric measurements like waist circumference, hip circumference, waist: hip ratio, body fat percentage, basal metabolic rate (BMR), total body water (TBW), lean body mass (LBM), neck circumference, upper mid arm circumference, calf circumference will be recorded. Urine pregnancy test will be performed for all females who have not reach menopause will undergo urine pregnancy test in local lab. After satisfying all eligibility criteria, investigator will perform detailed physical and systemic examination and will give patient a test request form for laboratory investigations. Based on these investigations, investigator will decide whether the subject is eligible to participate in the clinical trial study.
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