CTRI/2017/06/008787
Completed
Phase 2
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 sites103 target enrollmentTBD
ConditionsHealth Condition 1: null- Smokers
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Smokers
- Sponsor
- Gurseet Singh
- Enrollment
- 103
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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