| CTRI Number |
CTRI/2014/07/004727 [Registered on: 10/07/2014] 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 |
| LN/OB/JAN/LI12507F1/14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKVenkateshwarlu |
| Designation |
Principal Investigator |
| Affiliation |
Srinivasa Clinic and Diabetic Care Center |
| Address |
No.9, 50 Feet Main Road,
Girinagar,
Bangalore
Bangalore
KARNATAKA
560085
India |
| Phone |
|
| Fax |
|
| Email |
drvenkatesh64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A V Krishna Raju |
| Designation |
Project Manager |
| Affiliation |
Laila Nutraceuticals |
| Address |
Laila Nutraceuticals
Vijayawada
Krishna
ANDHRA PRADESH
520007
India |
| Phone |
|
| Fax |
|
| Email |
avkr@lailanutra.in |
|
Details of Contact Person
Public Query
|
| Name |
Shekhar Gupta |
| Designation |
Chief Operating Officer |
| Affiliation |
D2L Pharma Research Solutions |
| Address |
D2L Pharma Research Solutions
Whitefield ITPL Road,
Bangalore
Bangalore
KARNATAKA
560048
India |
| Phone |
080-30850666 |
| Fax |
|
| Email |
shekhar.gupta@d2lpharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Laila Nutraceuticals |
| Address |
Survey No 181/2, 181/3, 181/4B
JRD TATA Industrial Estate,
Kanuru,Vijayawada-520007
Ph: 0866-6636666
|
| Type of Sponsor |
Other [Nutraceutical Supplements Manufacturer] |
|
|
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 |
| DrKVenkateshwarlu |
Srinivasa Clinic and Diabetic Care Center |
No.9, 50 Feet Main Road,
Girinagar
Bangalore
KARNATAKA |
9945232107
drvenkatesh64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore Ethics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LI12507F1 |
Dose: 2 capsules (each capsule containing 400 mg of novel botanical formulation (LI12507F1) and excipients QS)
Frequency: BD
Duration: 112 Days
Route of Administration: Oral |
| Comparator Agent |
Placebo |
Dose: 2 capsules (each capsule containing excipients QS without LI12507F1 and resembles LI12507F1 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 |
• Subjects who signs the Informed Consent Form
• Male or female subjects between 21 to 50 years of age
• Subject with BMI range (27-32)
• 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 years 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 2,000 kcal/day (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 in all the scheduled visits.
• Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue these 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
|
|
| ExclusionCriteria |
| Details |
• Subjects suffered from intractable obesity, had defined weight limits or had experienced any recent, unexplained weight loss or gain
• Subjects having history of underlying inflammatory arthropathy septic arthritis inflammatory joint disease,gout,pseudo gout, Pagets disease,joint fracture, acromegaly, fibromyalgia, Wilsons 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 ≥ 140-199 mg/dl.
• Subject with Hyperuricaemia (males > 480 μmol/L, females > 450 μmol/L).
• Subjects having thyroid disease.
• 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 high alcohol intake (>2 standard drinks per day).
• Pregnant, breast feeding or planning t become pregnant during the study.
• Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
• Subjects participated in any investigational study medication with in thirty (30) days prior to screening
• Any other condition that, in the opinion of the investigator, would adversely affect the subjects ability to complete the study or its measures |
|
|
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
Modification(s)
|
| Outcome |
TimePoints |
| Reduction in Body Weight |
Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Change from the baseline to the end of the treatment period in :
• Reduction of BMI, Waist Hip ratio and improvement in Lean Body Mass measured through DEXA scan
•LDL, HDL, VLDL, TGL and Total Cholesterol
•Change in Serum biomarkers like Adiponectin, Leptin, Ghrelin and Insulin
|
Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2014 |
| 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- LI12507F1 versus placebo in over-weight (subjects whose BMI falls within the range of 27-32). 60 enrolled subjects in to two Study arms will receive either Investigational product or a placebo as supplement for a period of 112 Days (16 Weeks). It is hypothesized that supplementation of the study compound, may result in a statistically significant improvement in weight loss in the overweight healthy Subjects. LI12507F1 is a synergistic composition containing Garcinia mangostana extract and Sphaeranthus inducus extracts in a standardized proportion.
|