CTRI/2015/06/005835已完成不适用
A Randomized, Double-Blind, Placebo-Control Study to Evaluate Efficacy and Safety of novel herbal formulation on Weight Management in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Reduction of Body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ 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.
- •â€¢ Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) during the course of the study.
- •â€¢ Subject agrees to consume a vegetarian/non-vegetarian diet of approximately 1800 kcal/day (approximately 17% protein, 25% Fat and 58% carbohydrate).
- •â€¢ 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.
- •â€¢ Subject using other therapies for weight management including physiotherapy/ occupational therapy agrees to discontinue those therapies during this study.
- •â€¢ Subject agrees not to start any new therapies for weight loss during the course of the study.
- •â€¢ Subjects willing to go for DEXA analysis during the course of study.
- •â€¢ Subjects agree to maintain the activity dairy • Willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •â€¢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.
结局指标
主要结局
Reduction of Body weight
时间窗: Week 0, Week 2, Week 4, Week 8, Week 12 and Week 16
次要结局
- • Change from the baseline to the end of the treatment period in :(o Reduction of BMI)
研究者
研究点 (2)
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