Health Condition 1: null- Smokers
Conditions
Interventions
Intervention1: JPT -25 Tablet and or Capsules: JPT -25 Tablet and or Capsules contains Kaucha, Ashvagandha, Bala, Draksha, Sunthi, Yashtimadhu with permitted excipients, preservative etc.
Dosage and
Sponsors
Gurseet Singh
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assessment of cessation of smoking (reduction or complete giving up) 2. To assess changes in Lung capacity by using spirometry Timepoint: Day -5, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Monthly assessment lung capacity measured by a Spirometer 2. Assessment of monthly changes in CO and COHb levels 3. Assessment of quality of life on WHO QOL Questionnaire 4. Assessment of Cardiac risk markers 5. To assess level of Energy, stamina and physical strength 6. Level of stress using VAS 7. To assess serum cortisol and Total Testosterone 8. To assess anxiety on HAMA 9. Physicianâ??s Global evaluation 10. Global assessment of overall safety of drugsTimepoint: Day -5, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed