A Two Arm, Open Label, Randomized, Multi centric, Interventional, Prospective, Clinical Study to Evaluate Efficacy and Safety of SMOTECT-AZAADI granules in comparison with Nicotine Replacement Therapy (NRT) in Tobacco users (Chewing) - NI

Gurseet Singh,Project Happiness Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•1. Subjects habituated to a minimum of 3 times of Tobacco Chewing daily (Gutka etc.) for the last 1-year.
•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 female 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.

•1. Known cases of any severe/chronic disease which in the opinion of the investigator will be detrimental to the subject for participating in the study.
•2. Known case of any active malignancy.
•3. Subjects giving history of significant cardiovascular event 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. Subjects using any other investigational drug within 1 month prior to recruitment.
•8. Known hypersensitivity to any of the ingredients used in the study drug.
•9. Pregnant and Lactating females
•10. Subjects currently participating in any other Clinical study.
•11. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.

发起方

Gurseet Singh,Project Happiness Pvt Ltd