CTRI/2019/10/021611尚未招募不适用
An open label, single arm, prospective clinical study to evaluate safety and tolerability of Puremeric (Standardized extract from Curcuma longa) in healthy subjects.
Vidya Herbs P Ltd1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年10月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in liver function parameters from baseline to end of treatment
研究概览
简要总结
Thisis an open label, single arm, prospective clinical study. Healthy subjects meetingall inclusion and no exclusion criteria, after signing a written informedconsent will be enrolled in the study. After passing the eligibility criteria,subjects will receive Puremeric(standardized extract from Curcuma longa),500 mg orally, twice a day for 90 days. The subject will arrive at the studysite in a fasted state and blood samples will be collected for laboratoryassessment. The study will be conducted in 2 visits over a period of 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects having weight > 50 Kg 2.Subjects who have no evidence of any underlying disease 3.Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test.
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease) requiring medical treatment 2History of Chronic metabolic disease, Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol, Eating disorder such as bulimia or binge eating, Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery History of any major surgery 3Subjects allergic to herbal products 4Known HIV or Hepatitis B positive or any other immuno-compromised state 5Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subject’s safety and preclude trial participation 6Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study 7.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Changes in liver function parameters from baseline to end of treatment
时间窗: Day 0, Day 90
次要结局
- Changes in other Laboratory parameters and Vital Signs(Day 0, day 90)
- Incidence of AE/SAEs(Day 0, Day 90)
研究者
研究点 (1)
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