To evaluate Efficacy and Safety of proprietary Herbal Formulation for Weight Management in Healthy Volunteers

Completed

• Conditions: Overweight

• Registration Number: CTRI/2014/07/004727
• Lead Sponsor: Laila Nutraceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-30
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• •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.

Exclusion Criteria

• •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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Body Weight	Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Srinivasa Clinic and Diabetic Care Center; 🇮🇳 Bangalore, KARNATAKA, India

Srinivasa Clinic and Diabetic Care Center

🇮🇳Bangalore, KARNATAKA, India

DrKVenkateshwarlu

Principal investigator

9945232107

drvenkatesh64@gmail.com