A Clinical Study on SMOTECT-AZAADI granules

Not Applicable

Completed

• Registration Number: CTRI/2023/07/055111
• Lead Sponsor: Gurseet Singh,Project Happiness Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in cessation of chewing of tobacco/gutka etc. (reduction or complete cessation, with respect to number of users & frequency of usage)Timepoint: Screening Visit (Up to 7 days), Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90), Visit 7 (Day 120)