None listed
Conditions
Interventions
None listed
Sponsors
Project Happiness Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects consuming a minimum of 4 packets (approx. 10 gm) gutka daily for more than 5 years 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 or equal 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 Severe or Chronic disease 2. Known subject of any active malignancy. 3. Subjects giving history of significant cardiovascular event less than or equal to 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 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 started in the exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in nicotine (chewable tobacco) addiction (average amount of gutka consumed between study visits and number of days required for reduction or complete cessation)Timepoint: Screening visit (Day -3), Baseline visit (Day 0), Visit 1 (day 15), and Visit 2 (Day 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Assessment of quality of life (QOL) on WHO QOL Questionnaire. 2. Assessment of level of Energy, level of stamina and physical strength on a 7- point scale 3. Assessment of level of stress using VAS 4. Assessment of change in daytime fatigue on VAS 5. Change in clinical symptoms related to chewable tobacco or gutka 6. Assessment of oral health (mouth opening capacity) and mouth ulcers 7. Change in Global evaluation for overall change on CGI-I Scale as per physician and subjects 8. Assessment of adverse events 9. Change in global assessment of overall safety of study drug as per the physician and subjects Timepoint: Screening visit (Day -3), Baseline visit (Day 0), Visit 1 (day 15), and Visit 2 (Day 30) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt Ltd
Outcome results
None listed