A randomized, double blind, placebo controlled, clinical study to evaluate the efficacy and safety of Curcuma caesia for weight management in obesity.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 2 Biomarkers.
研究概览
简要总结
A prospective, randomized, double blind, placebo controlled study in 60 adult male or female patients with BMI in the range of 35 to 40 kg/m2 both inclusive will be conducted to evaluate the efficacy and safety of Curcuma caesia capsules. The individual subject participation will be for 90 days followed by a telephonic follow up visit. The primary assessments for the study are body weight, body mass index, biomarkers, lipid profile, anthropometric measurements, clinical photographs and quality of life questionnaire. The secondary assessments for the study are adverse events, abnormal vital signs and abnormal laboratory parameters. 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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Male and/or female patients.
- •2 Age between 20 to 60 years.
- •3 BMI between > 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/ genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Praderwilli syndrome).
- •3 Patients with evidence of malignancy.
- •4 Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergic, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •5 Symptomatic patient with clinical evidence of Heart failure.
- •6 History of HIV and other viral infections.
- •9 Pregnant / lactating woman.
- •10 Patients who have completed participation in any other clinical trial during the past six (06) months.
- •11 Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
2 Biomarkers.
时间窗: 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5). | 2 Biomarkers(Baseline & Final visit). | 3 Lipid Profile(Screening & Final visit). | 4 Anthropometric measurements(Baseline,Day30,Day60 & Day90). | 5 Clinical Photographs(Screening & Final visit). | 6 QOL Questionnaire (Baseline & Final visit).
1 Body weight and BMI.
时间窗: 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5). | 2 Biomarkers(Baseline & Final visit). | 3 Lipid Profile(Screening & Final visit). | 4 Anthropometric measurements(Baseline,Day30,Day60 & Day90). | 5 Clinical Photographs(Screening & Final visit). | 6 QOL Questionnaire (Baseline & Final visit).
3 Lipid Profile.
时间窗: 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5). | 2 Biomarkers(Baseline & Final visit). | 3 Lipid Profile(Screening & Final visit). | 4 Anthropometric measurements(Baseline,Day30,Day60 & Day90). | 5 Clinical Photographs(Screening & Final visit). | 6 QOL Questionnaire (Baseline & Final visit).
4 Anthropometric measurements.
时间窗: 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5). | 2 Biomarkers(Baseline & Final visit). | 3 Lipid Profile(Screening & Final visit). | 4 Anthropometric measurements(Baseline,Day30,Day60 & Day90). | 5 Clinical Photographs(Screening & Final visit). | 6 QOL Questionnaire (Baseline & Final visit).
5 Clinical Photographs.
时间窗: 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5). | 2 Biomarkers(Baseline & Final visit). | 3 Lipid Profile(Screening & Final visit). | 4 Anthropometric measurements(Baseline,Day30,Day60 & Day90). | 5 Clinical Photographs(Screening & Final visit). | 6 QOL Questionnaire (Baseline & Final visit).
6 QOL Questionnaire.
时间窗: 1 Body weight and BMI(Screening,Visit3,Visit4 & Visit5). | 2 Biomarkers(Baseline & Final visit). | 3 Lipid Profile(Screening & Final visit). | 4 Anthropometric measurements(Baseline,Day30,Day60 & Day90). | 5 Clinical Photographs(Screening & Final visit). | 6 QOL Questionnaire (Baseline & Final visit).
次要结局
- 1 Adverse or serious adverse events.(2 Abnormal vital signs.)