CTRI/2024/12/078448进行中（未招募）Phase 3 4
A Double Blind, Placebo-Controlled, Randomized, Parallel-Group Clinical Trial to Investigate the Effectiveness of HT099 Intake on Body Fat Composition and Blood Lipid Levels in Overweight Adults.
Leads Clinical Research and Bio Services Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月2日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the efficacy of HT099 in comparison with placebo on the reduction in body fat mass using Dual Energy X-ray Absorptiometry (DEXA) in overweight subjects
研究概览
简要总结
This is a double blind, placebo-controlled, randomized, parallel-group study. Adult overweight subjects meeting all inclusion and no exclusion criteria, after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 2 treatment arms (50:50) to receive either HT099 or placebo, orally, once a day for 84 days. Each subject will visit the site 5 times during the conduct of the study over a period of 84 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Overweight subjects with BMI between 25-30 kg/m²
- •Subject willing to adhere with their routine diet and exercise regimen throughout the study
- •Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
- •Subject willing and able to give informed consent and comply with the study procedures.
排除标准
- •Hypertension patients with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, or those taking diuretics
- •Diabetes patients with fasting blood glucose ≥ 126 mg/dL or random blood glucose ≥ 200 mg/dL, or those taking oral hypoglycemic agents or insulin 3.Subjects with heart, kidney, liver, thyroid, or cerebrovascular diseases
- •Subjects with gallbladder disease, gastrointestinal diseases, gout, or porphyria
- •Subjects with psychiatric disorders such as depression, schizophrenia, alcoholism, or drug addiction
- •Subjects taking obesity treatments (lipase inhibitors, antidepressants, appetite suppressants, contraceptives, steroids, or female hormones)
- •Pregnant or breastfeeding women
- •Subjects who have taken obesity programs or diet supplements within 30 days prior to the study
- •Subjects who are deemed unable to exercise due to severe musculoskeletal disorders
- •Subjects diagnosed with or treated for cancer within the past 5 years
- •Subjects with asthma or other allergic diseases
- •Subjects with a history of surgery within the past 6 months
- •Subjects with a history of drug or alcohol addiction
- •Subjects who participated in another clinical trial within 3 months prior to the study start date
- •Subjects who cannot read or have limited reading ability
- •Subjects deemed unsuitable by the investigator for any other reason start date.
结局指标
主要结局
To assess the efficacy of HT099 in comparison with placebo on the reduction in body fat mass using Dual Energy X-ray Absorptiometry (DEXA) in overweight subjects
时间窗: Baseline and Day 84
次要结局
- Mean Change in anthropometric parameters and body composition(Baseline, Day 28, Day 56, Day 84)
- Mean Change abdominal fat(Baseline and Day 84)
- Mean Change in Biomarkers(Baseline, Day 28, Day 56, Day 84)
- Overall Safety(Baseline, Day 28, Day 56, Day 84)
研究者
Dr Harshith C S
BGS Global Institute of Medical Sciences
研究点 (1)
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