A randomized,double blind,placebo controlled,three group study to evaluate the comparative efficacy and safety of Curcuma caesia and Forskolin and Curcuma caesia for weight management in obese patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1 Change in body weight and BMI.
研究概览
简要总结
A prospective, randomized, double blind, placebo controlled study in 36 adult male or female patients with BMI in the range of greater than equal to 35 to 40 kg/m2 will be conducted to evaluate the efficacy and safety of Curcuma caesia and Forskolin capsules. The individual subject participation will be for 90 days followed by a telephonic follow up visit. The efficacy assessments for the study are body weight, body mass index, DEXA, lipid profile, anthropometric measurements and clinical photographs. The safety assessments for the study are adverse or serious adverse events, vital signs and laboratory investigations. Statistical analysis will be performed as listed in the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male and/or female patients.
- •2 Age between 20 to 55 years.
- •3 BMI between greater than 35 to 40 kg/m
- •4 Willing to come for regular follow up visits.
- •5 Able to give written informed consent.
排除标准
- •1 Intake of over the counter weight loss agents, centrally acting appetite suppressants in the previous six months.
- •2 Pathophysiologic or genetic syndromes associated with obesity like Cushing’s syndrome, Turner’s syndrome, Praderwilli syndrome.
- •3 Patients with evidence of malignancy.
- •4 History of poorly controlled Diabetes Mellitus.
- •or any other drugs that may have an influence on the outcome of the study.
- •6 Symptomatic patient with clinical evidence of Heart failure.
- •7 History of HIV and other viral infections.
- •8 Prior surgical therapy for obesity.
- •9 History of hypersensitivity to any of the herbal extracts or dietary supplement.
- •10 Pregnant or lactating woman.
- •11 Patients who have completed participation in any other clinical trial during the past six months.
- •12 Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
1 Change in body weight and BMI.
时间窗: 1 Change in body weight and BMI(Screening,Day30,Day60 and Day90). | 2 Change in DEXA analysis(Day0 and Day90). | 3 Change in Lipid Profile(Screening and Day90). | 4 Change in anthropometric measurements(Baseline,Day30,Day60 and Day90). | 5 Clinical Photographs(Screening and Day90).
2 Change in DEXA analysis.
时间窗: 1 Change in body weight and BMI(Screening,Day30,Day60 and Day90). | 2 Change in DEXA analysis(Day0 and Day90). | 3 Change in Lipid Profile(Screening and Day90). | 4 Change in anthropometric measurements(Baseline,Day30,Day60 and Day90). | 5 Clinical Photographs(Screening and Day90).
3 Change in Lipid Profile.
时间窗: 1 Change in body weight and BMI(Screening,Day30,Day60 and Day90). | 2 Change in DEXA analysis(Day0 and Day90). | 3 Change in Lipid Profile(Screening and Day90). | 4 Change in anthropometric measurements(Baseline,Day30,Day60 and Day90). | 5 Clinical Photographs(Screening and Day90).
4 Change in anthropometric measurements.
时间窗: 1 Change in body weight and BMI(Screening,Day30,Day60 and Day90). | 2 Change in DEXA analysis(Day0 and Day90). | 3 Change in Lipid Profile(Screening and Day90). | 4 Change in anthropometric measurements(Baseline,Day30,Day60 and Day90). | 5 Clinical Photographs(Screening and Day90).
5 Clinical Photographs.
时间窗: 1 Change in body weight and BMI(Screening,Day30,Day60 and Day90). | 2 Change in DEXA analysis(Day0 and Day90). | 3 Change in Lipid Profile(Screening and Day90). | 4 Change in anthropometric measurements(Baseline,Day30,Day60 and Day90). | 5 Clinical Photographs(Screening and Day90).
次要结局
- 1 Adverse Events.(2 Serious Adverse Events.)