A randomized, double-blind, placebo-controlled clinical study to evaluate the effect of herbal compositions CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from baseline to the end of the study period in:
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of herbal compositions CL19183 and CL24212 on body weight, body composition and metabolic health in overweight subjects. Enrolled subjects will receive CL19183 – 450 mg or CL24212 – 300 mg or placebo capsules. A total of 150 male and female subjects aged between 25 and 55 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either CL19183:450 mg or CL24212 : 300 mg or Placebo arm at 1:1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast for 16 weeks. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of the CL19183 and CL24212 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
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
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female subjects aged between 25-55 years with body mass index (BMI) of
- •29.9 kg/m
- •2.Subjects with sedentary lifestyle, no regular athletic or sports activities. 3.Subjects willing to participate in walking-exercise (5 days a week, 30 min per day) over study duration. 4.Subjects with normal thyroid hormone profile. 5.Subjects agreed to consume recommended standard diet. 6.Subjects who are willing to abstain from alcohol, coffee, tea, cola, energy drinks & chocolate for at least 24 hrs. prior to visits and final visit. 7.Subjects who are non-smokers. 8.Subject agrees to maintain diet tracker. 9.Subject considered generally healthy as per health history and routine clinical investigations during screening. 10.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. 11.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
排除标准
- •1.Subjects who were taking medications which affect the metabolic rate (e.g. antidepressants, beta-blockers, hormones, etc.).
- •2.Subjects on weight loss practices, usage of weight reduction supplements/nutrition products will be excluded.
- •3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •4.Subjects participated in any weight loss programs within 3 months.
- •5.Subjects who are diabetic and/or hypertensive.
- •6.Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
- •7.Subjects taking medications for or suffering from a medical condition that could impact results related to metabolism (e.g., thyroid disorders, diabetes, mental disorders such as anxiety or depression, heart disease, arthritis, cancer).
- •8.Subjects with HIV Positive.
- •9.Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study.
- •10.Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •11.Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
- •12.Use of nutritional supplements (e.g., creatine, protein drinks, amino acids, or vitamins) or ergogenic aids and caffeinated and not caffeinated thermogenics within 30 days prior to the study.
- •13.Subjects who are participated or currently participating in another clinical trial within 30 days prior to screening.
结局指标
主要结局
Change from baseline to the end of the study period in:
时间窗: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16
Body weight
时间窗: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16
次要结局
- Change from baseline to the end of the study period in:(Body mass index (BMI))
- Change from baseline to the end of the study period in:(Body composition using DEXA (including fat and lean mass))
- Change from baseline to the end of the study period in:(Waist and Hip circumference (WC & HC))
- Change from baseline to the end of the study period in:(Waist to hip ratio (WHR))
- change from baseline to the end of the study period in:(Lipid profile (including ApoB and amyloid A))
- Change from baseline to the end of the study period in:(Adiponectin, ghrelin, total glucagon-like peptide 1(GLP-1), C-Peptide, Glucagon, VCAM-1, and ICAM-1)
研究者
Dr Annavarapu Tirupathi Rao
CLS Pvt Ltd