None listed
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants having a history of smoking a minimum of 5 cigarettes daily. 2. Willing to quit (assessed by RCQ greater than 5) and provide written consent for intervention and follow-up of 45 days in the study.
Exclusion criteria
Exclusion criteria: 1. Participants with major illness. 2. Those having associated addiction or substance abuse, and smokeless tobacco users. 3. Uncontrolled hypertension(greater than 160 mmHg) or diabetes. 4. Pregnant and lactating women. 5. Any significant psychiatric illness or mood disorders. 6. Those taking any anti-smoking medication or nicotine replacement therapy(NRT) in the previous month. 7. Those who are taking any other medications interfering with the treatment protocol. 8. Those with known hypersentivity to any ingredients of the study drug. 9. Those who are not willing to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in severity and frequency of withdrawal symptoms assessed by POMS (Profile of Mood State) and questionnaire using the Likert scale.Timepoint: Intervention period - 1 month Follow up - 15 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in smoking (number of cigars taken per day) assessed using the Fagerstrom Test for Nicotine Dependence (FTND) scale.Timepoint: Intervention period - 1 month follow up - 15 days | — |
Countries
India
Contacts
All India Institute of Ayurveda