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CTRI Number  CTRI/2015/06/005835 [Registered on: 01/06/2015] Trial Registered Retrospectively
Last Modified On: 17/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate Efficacy and Safety of proprietary Herbal Formulation for Weight Management in Healthy Volunteers  
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Control Study to Evaluate Efficacy and Safety of novel herbal formulation on Weight Management in Healthy Volunteers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Venkateshwarlu 
Designation  Consultant- Ayurvedic & Herbal Clinical Trials 
Affiliation  ANASUYA AYURVEDIC CLINIC 
Address  50 feet Main Road,Hanumanthanagar, Bangalore

Bangalore
KARNATAKA
560050
India 
Phone  9945232107  
Fax    
Email  drvenkatesh64@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  A V Krishna Raju  
Designation  Head, Project Management 
Affiliation  Laila Nutraceuticals 
Address  Survey No 181/2, 181/3, 181/4B,JRD TATA Industrial Estate, Kanuru,Vijayawada

Krishna
ANDHRA PRADESH
520007
India 
Phone  08666636666  
Fax    
Email  avkr@lailanutra.in  
 
Details of Contact Person
Public Query  
Name  Shekhar Gupta  
Designation  Chief Executive Officer 
Affiliation  D2L Clinical Solutions Pvt.Ltd. 
Address  1st Floor, Nandi Infotech, Plot no.8, 1st Cross, Sadarmangala Industrial Area, ITPL Whitefield Road, Bangalore

Bangalore
KARNATAKA
560048
India 
Phone  08030850666  
Fax    
Email  shekhar@d2lclinical.com  
 
Source of Monetary or Material Support  
Laila Nutraceuticals 
 
Primary Sponsor  
Name  Laila Nutraceuticals 
Address  Survey No 181/2, 181/3, 181/4B JRD TATA Industrial Estate, Kanuru,Vijayawada-520007 
Type of Sponsor  Other [Nutraceutical Supplements Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kashinath Dixit  Krupa Centre for Diabetes and Obesity  Krupa Centre for Diabetes and Obesity Usha Nivas, 1149, opp. Shankar Matt,West of Chord Road, II Stage,Bangalore
Bangalore
KARNATAKA 		 080-33512210

doctorhck@yahoo.co.in 
Dr Dinesh V Kamath  Sudeep Diabetes Care Centre  Sudeep Diabetes Care Centre No. 84, Soundarya Paramount,5th Cross, Malleshwaram,Bangalore-560003
Bangalore
KARNATAKA 		 080-23362019

dineshvkamath@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Bangalore Ethics  Approved 
Bangalore Ethics  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Over-weight 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LI85008F  Dose: 2 capsules (each capsule containing 450 mg of novel botanical formulation (LI85008F),Frequency: BD Duration: 112 Days Route of Administration: Oral  
Comparator Agent  Placebo  Dose: 2 capsules (each capsule containing excipients QS without LI85008F and resembles LI85008F capsules in weight and all organoleptic characteristics) Frequency: BD Duration: 112 Days Route of Administration: Oral  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  • Male or female subjects between 21 to 50 years of age
• Subject with BMI range (27-29.9)
• Ability to understand the risks/benefits of the protocol
• Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera ®, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
• Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) during the course of the study.
• Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 1800 kcal/day (approximately 17% protein, 25% Fat and 58% carbohydrate).
• Subject should be available for duration of study period (6-8 months)
• Subject agrees to come to site in fasting state for their weight measurement and other laboratory parameters examination at all the scheduled visits.
• Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue those therapies during this study.
• Subject agrees not to start any new therapies for weight loss during the course of the study.
• Subjects willing to go for DEXA analysis during the course of study.
• Subjects agree to maintain the activity dairy
• Willing to give written informed consent and willing to comply with trial protocol. 
 
ExclusionCriteria 
Details  •Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain two months prior to screening.
• Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget disease, joint fracture, acromegaly, fibromyalgia, Wilson disease, ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
• Subjects having history of asthma
• Subjects having history of cardiovascular diseases
• Subjects having history of diabetes (Type I or Type II) - except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose between 140-199 mg/dl.
• Subject with Hyperuricaemia (males > 480 µmol/L, females > 450 µmol/L).
• Subjects having thyroid diseases.
• Subjects having abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal, elevated Creatinine, males > 125 µmol/L, females > 110 µmol/L).
• Subjects having abnormal findings on complete blood count.
• Subjects having history of coagulopathies.
• Subjects with hypertension.
• Subjects with HIV Positive.
• Subjects having history of congestive heart failure.
• Subjects having history of high alcohol intake (>2 standard drinks per day).
• Pregnant, breast feeding or planning to become pregnant during the study.
• Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
• Any other condition that, in the opinion of the investigator, would adversely affect the ability of subjects to complete the study or its measures.
• Subjects participated in any investigational study medication within thirty (30) days prior to screening.
• Use of any weight loss medications or any supplements, programs, or meal replacement products intended to alter body weight within two months prior to screening or during the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of Body weight  Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16 
 
Secondary Outcome  
Outcome  TimePoints 
• Change from the baseline to the end of the treatment period in :
o Reduction of BMI
o Change in Waist Hip ratio
o Reduction in body fat and improvement in Lean body mass (Body-fat composition analysis by DEXA
o HDL, LDL, VLDL, Total cholesterol and Triglyceride (TGL)
• Endpoints for Safety
o Tolerability and acceptance as recorded in the subject daily diary &compliance card.
o Adverse events (AEs), frequency and severity.
• Changes in the vital parameters 		 Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/05/2015 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The purpose of this study is to assess the clinical effectiveness of novel formulation LI85008F, i.e., Adipromin on healthy Overweight population. Adipromin is a synergistic composition of three commonly used medicinal plants extracts, which are well recognized and widely used in Ayurvedic system of medicine for treating a variety of diseases and have been used for culinary purposes for thousands of years. It has been assessed and established that the Adipromin is engaged in inhibition of adipogenesis and exhibits the ability to enhance lipid breakdown i.e. lipolysis. In addition, LI85008F enhanced triglyceride mobilization from the fat cells or promoted lipolysis. A clinical study has been performed and initial safety and effectiveness of Adipromin is established. The present Study is to validate the efficacy and use of Adipromin in reduction of body weight in overweight subjects.

 
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