CTRI/2020/08/027196已完成不适用
An Open Label, Single Arm, Prospective Clinical Study To Evaluate Efficacy And Safety Of Slim Honey In Obese Subjects
Royal Bee Natural Products Pvt Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in body weight (kg)
研究概览
简要总结
The study is designed as Open label, prospective, interventional and observational study. Subject will be assigned to receive Slim Honey. Parameters of anthropometric measurements and quality of life questionnaires will be assessed. Safety parameters like hematology and biochemistry will be assessed if required.
AE/SAE will be recorded during the conduct of the study.
The study will enroll subjects of age group 18 to 65 years. The regulatory approvals are taken care by MGCTS (Mittal Global Clinical Trial Services).
A total of 30 cases will be enrolled in one group with BMI between 25-34.9 Kg/m2.
All the subjects will receive test drug Slim Honey
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and/or female volunteers aged between 18 to 65 years both inclusive.
- •3.Willing to do exercise for a span of 30 minutes daily for at least5 days in a week.
- •4.Willing to follow diet advised by investigator 5.Willing to come for regular follow-up visits.
排除标准
- •1.Intake of over the counter weight loss agents, centrally acting appetite suppressants or prior surgery for obesity in the previous three months.
- •2.History of pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, and Parder- Willi Syndrome).
- •3.Alcoholics and subjects with substance abuse.
- •4.Subject with evidence of malignancy 5.Subjects having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, rheumatoid arthritis.
- •6.Subjects having history of coagulopathies, cardiovascular diseases, asthma.
- •7.Subjects with HbAlc> 7 % and poorly controlled diabetes mellitus, poorly controlled hypertension.
- •8.TSH > 10 mIU/L and T3 and T4 higher than normal range.
- •9.Pregnant and lactating women.
- •10.Subjects with hepatic and renal failure.
- •11.Subjects on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc.
- •12.Subjects with hypersensitivity to any one ingredient of the drugs.
- •13.Subjects who have participated in other trial within last 3 months.
- •14.Any other condition which the principal investigator thinks may jeopardize the study.
结局指标
主要结局
change in body weight (kg)
时间窗: 6 weeks
次要结局
- Tolerability of drugs(6 weeks)
- Change in anthropometric measurements(6 weeks)
- Change in quality of life(6 weeks)
研究者
研究点 (1)
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