Health Condition 1: F172- Nicotine dependence
Conditions
Interventions
Intervention1: Group I: Homeopathic Medicine Cytisus Laburnum (CL) + RYM: Cystisus 6C 4 pills/ thrice daily for 15 days, followed by Cystisus 30C, 4 pills / thrice daily for 15 days, followed by Cys
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 65 years of both genders. 2. Daily tobacco users willing to attempt cessation. 3. Daily tobacco users currently smoking 10 or more cigarettes per day or consuming smokeless tobacco such as ghuta, Khaini (at least 10 units or more a day) 4. Willing to participate in Rajyoga meditation sessions. 5. Participants with controlled Diabetes and Controlled Hypertension. 6. Willing to give voluntarily written Informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant ladies and breastfeeding mothers. 2 Known cases of HIV, Chronic kidney disease, cancer, myocardial infarction, unstable angina, cerebrovascular incident, or hospitalization for congestive heart failure. 3. Current use of pharmacological cessation therapy. 4. Co-morbid major psychiatric conditions. (Major depressive disorder, bipolar disorder; threats of suicide or repeated deliberate self-harm; current psychotic disorder). 5. Other substance dependence (alcohol, cocaine, cannabis, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Feasibility Outcomes Recruitment rate per month. Retention of participants throughout the trial. Adherence to study medication and Raj yoga sessions. Blinding integrity. Completeness of outcome data.Timepoint: Baseline, Day 2, Weekly from 1 to 12 weeks(short-term) and at weeks 16, 20, and 24 (longer-term) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in severity of dependency using the Fagerstrom test for nicotine dependence (FTND) Timepoint: Baseline, weekly from 1 to 12weeks (short-term) and at weeks 16, 20, and 24 (longer-term);Proportion of participants with tobacco abstinence, defined as self-reported non-smoking since the last assessment visit (self-reported) as assessedTimepoint: Baseline, Day 2, weekly from 1 to 12 (short-term) and at weeks 16, 20, and 24 (longer-term) using self-report.;Change in tobacco craving (smoking urge) using the withdrawal/craving scale, the Smoking Urges Brief Questionnaire. (QSU-Brief)Timepoint: Baseline, weekly from 1 to 12weeks(short-term) and at weeks 16, 20, and 24;To assess the change in plasma/ saliva/ and urine cotinine levelsTimepoint: Baseline, month 3, and month 6.;Biochemical parameters (HbA1c, lipid profile, CBC, LFTs, KFTs)Timepoint: Baseline and month 6;Changes in Hospital Anxiety and Depression Scale scoreTimepoint: Baseline, weekly from 1 to 12weeks (short-term) and at weeks 16, 20, and 24;Changes in withdrawal symptoms and signs, if any, using the NRS scaleTimepoint: Daily for 10 days. (Physically /telephonic follow-up) | — |
Countries
India
Contacts
Public ContactDr Shweta Gautam
Central Council for Research in Homoeopathy
Outcome results
None listed