CTRI/2016/08/007221已完成未知
A randomized, double blind, placebo controlled, cross over study to evaluate the safety and efficacy of Gymnema Sylvestre capsule (600 mg) in improving post-prandial blood glucose levels in male and female healthy volunteers
GWELL CO LTD0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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 Normal healthy human adult male and female volunteers between 18-45 years -both ages inclusive, of age, who have given written informed consent and are willing to participate in the study.
- •2 Volunteer having Body Mass Index of 18.5 to 24.9 Kg/m2 -Inclusive.
- •3 Volunteer with no evidence of underlying disease during the pre-study screening,medical history, physical examination and laboratory investigations performed within 21 days prior to commencement of the study.
- •4 Volunteer whose pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to his participation in the study.
- •5 Volunteer having a 12 lead ECG recording within normal limits.
- •6 Volunteer with normal chest X-ray taken within 6 months before the day of dosing.
- •7 Volunteer will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
排除标准
- •1 Volunteer who is allergic to Gymnema Sylvestre or any component of the formulation and to any other related drug.
- •2 Volunteer with history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease.
- •3 More specifically, volunteer with history or presence of significant:
- •History of chronic smoking -10 or more than 10 units per day of
- •cigarettes, bidis, or any other form- or chronic consumption of
- •tobacco products.
- •History of clinically relevant allergy -except for untreated,
- •asymptomatic, seasonal allergies at time of dosing- or any
- •allergic reactions to any drugs.
- •Asthma, urticaria or other allergic type reactions after taking any
- •medication.
- •Clinically significant illness within 4 weeks before the start of the
- •Hypersensitivity to heparin.
- •4 History of Vascular collapse.
- •5 Volunteer who is scheduled for surgery within 7 days after study completion.
- •6 Volunteer who, through completion of any other clinical study or otherwise would have donated in excess of 350 mL of blood in the last 90 days.
- •7 Volunteer who has taken prescription medication or over-the- counter products -including vitamins and products from natural origin- within 14 days prior to administration of IP, including topical medication meant for systemic absorption.
- •8 Volunteer who was hospitalized within 28 days prior to administration of the study medication.
- •9 Volunteer with history of difficulty in swallowing.
- •10 Volunteer who has unsuitable veins for repeated venipuncture.
- •11 Any abnormal laboratory value or physical finding which may interfere with the interpretation of test results or cause a health hazard for the volunteer if he participates in the study.
- •12 Volunteer who has:
- •Systolic blood pressure less than 90 mm of Hg or more than 150
- •mm of Hg Diastolic blood pressure less than 60 mm of Hg or more
- •than 94 mm of Hg.
研究者
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