CTRI/2017/06/008787已完成2 期
A Two Arm, Double Blind, Randomized, Prospective, Multi centric, Placebo controlled, Clinical Study to Evaluate Efficacy and Safety of JPT-25 in Smokers - NI
Gurseet Singh0 个研究点目标入组 103 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
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 smoking a minimum of 5 cigarettes or bidis daily for at least 3 years and showing a high level of alveolar CO levels.
- •2. Subjects not suffering from any significant illness (medical or surgical).
- •3. Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless the subject has had a hysterectomy, tubal ligation, or is greater than 2 years postmenopausal.
- •4. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1. Known cases of Severe/Chronic disease.
- •2. Known subject of any active malignancy.
- •3. Subjects giving a history of significant cardiovascular event less than 12 weeks prior to randomization.
- •4. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •5. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •6. Subjects with uncontrolled Diabetes and Hypertension.
- •7. Pregnant and Lactating females.
研究者
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