None listed
Conditions
Interventions
None listed
Sponsors
Gurseet Singh,Project Happiness Pvt Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in effect on mouth opening capacity 2. Change in oral health-related parameters 3. Change in quality of life (QOL) assessed using WHO QOL BREF Questionnaire 4. Change in level of Energy, level of stamina & physical strength 5. Assessment of onset & duration of action with respect to levels of energy, freshness, and alertness 6. Change in level of stress using PSS 7. Changes in symptoms related to digestive system 8. Change in sleep quality assessed using PSQI 9. Assessment of physician’s and subject’s global evaluation for overall change 10. Changes in clinical symptoms related to Chewing Tobacco including 11. Assessment of relapse of use of Gutka (Tobacco) 12. Assessment of Adverse Drug Reaction and laboratory investigations 13. Global assessment of overall safety of study products 14. Assessment of overall sensorial feeling on the consumption of IP 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) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed