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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z682||Body mass index (BMI) 20-29, adult,  
 
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. 
 
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. 
 
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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