CTRI/2019/10/021611尚未招募未知
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 Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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.
- •4. 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 subjectâ??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
研究者
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