| CTRI Number |
CTRI/2025/09/094290 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Simplified Kundalini Yoga in Tobacco Cessation among alcohol dependent adult men |
|
Scientific Title of Study
|
3i Model Vethathirian Contemplative Talk-less Therapy of Simplified Kundalini Yoga in Tobacco Cessation Among Adult Men With Alcohol Dependence |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meena priya |
| Designation |
Professor |
| Affiliation |
JKKN Dental College & Hospital |
| Address |
JKKN Dental College & Hospital,
NH-544
(Salem to Coimbatore National Highway),
Kumarapalayam (TK),
Namakkal (DT)
Namakkal
TAMIL NADU
638183
India |
| Phone |
9865248844 |
| Fax |
|
| Email |
meenapriya@jkkn.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Meena priya |
| Designation |
Professor |
| Affiliation |
JKKN Dental College & Hospital |
| Address |
JKKN Dental College & Hospital,
NH-544
(Salem to Coimbatore National Highway),
Kumarapalayam (TK),
Namakkal (DT)
Namakkal
TAMIL NADU
638183
India |
| Phone |
9865248844 |
| Fax |
|
| Email |
meenapriya@jkkn.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Meena priya |
| Designation |
Professor |
| Affiliation |
JKKN Dental College & Hospital |
| Address |
JKKN Dental College & Hospital,
NH-544
(Salem to Coimbatore National Highway),
Kumarapalayam (TK),
Namakkal (DT)
Namakkal
TAMIL NADU
638183
India |
| Phone |
9865248844 |
| Fax |
|
| Email |
meenapriya@jkkn.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
WCSC - Vision Research centre |
| Address |
Temple of consciousness,
Arutperumjothi nagar,
Aliyar,
Pollachi,
Tamilnadu,
PIN- 642101 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMeenapriya |
WCSC - Vision Research Centre |
Temple of Consciousness,
Department of Yoga for Human Excellence,
Arut perum jothi nagar, Aliyar
Coimbatore
TAMIL NADU |
9865248844
meenapriya@jkkn.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WCSC - R&D Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3i model of Vethathirian Contemplative Talk-less Therapy |
3i model encompasses an assortment of three techniques in Simplified Kundalini Yoga, designed by Vethathiri maharishi, viz, inner travel meditation (agathavam), inner silence (mounam) and introspection (agathaivu). Intervention group:
Two-Phase Intervention Arm
Phase 1 (Weeks 1 – 4):
(1) Pharmacotherapy (standardized protocol for 8 weeks)
(2) 3i Model of Vethathirian Talk-less Therapy (2 sessions/week for 4 weeks, total 8 sessions)
Phase 2 (Weeks 5 – 8):
(1) Continuation of pharmacotherapy
(2) Psychotherapy (2 sessions/week for 4 weeks, total 8 sessions)
(3) Monitored self-practice Talk-less therapy (1 session/ week for 4 weeks)
Two phases - total 20 sessions
|
| Comparator Agent |
Psychotherapy |
Cognitive Behaviour Therapy and Motivational Interviewing.
Comparator agent Group:
Standard Intervention Arm (8 Weeks)
(1) Pharmacotherapy (standardized protocol for 8 weeks)
(2) Psychotherapy (standardized protocol - 2 sessions/week for 8 weeks, total 16 sessions)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
(1) Males aged 18 years and above
(2) Tobacco users with alcohol dependence (ICD-10 diagnosis)
(3) Willingness to participate and give informed consent
|
|
| ExclusionCriteria |
| Details |
1.Severe psychiatric illness (e.g., psychosis, severe depression with suicidality, bipolar disorder)
2.Serious systemic illness (e.g., decompensated liver disease, uncontrolled hypertension, cardiovascular instability, severe COPD/asthma)
3.Women (pregnant or non-pregnant)
4.Individuals currently enrolled in another cessation program or clinical trial
5.Cognitively impaired individuals unable to understand study procedures |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the change in tobacco use in:
o Group A: receiving pharmacotherapy and psychotherapy for 8 weeks
o Group B: receiving pharmacotherapy with 3i Vethathirian Talkless Therapy (first 4 weeks) followed by psychotherapy (next 4 weeks)
2. To verify behavioural outcomes using biochemical markers:
o Urinary/salivary cotinine strips for tobacco cessation
o CO breath analyser for smoking status
o uEtG (Urinary Ethyl Glucuronide) strips for alcohol abstinence
3. To evaluate withdrawal symptoms using the CIWA-Ar scale and compare symptom reduction between the groups at Week 4 and Week 8.
|
At the end of 4th, 8th and 12 th weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To examine the additive effect of staged intervention (3i followed by psychotherapy) on:
o Motivation for abstinence
o Emotional regulation
o Craving reduction
2. To evaluate participant adherence and acceptability of the two-phase protocol.
3. To determine the feasibility of integrating 3i Talk-less Therapy as an alternative / adjunct to standard care in addiction rehabilitation settings.
|
End of 4th, 8th and 12th Weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2055 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to evaluate the effectiveness and feasibility of a two-phase intervention model for addiction rehabilitation. The first phase involves 3i model of Talkless Therapy comprised of inner travel meditation, inner silence and introspection, followed by standard psychotherapy. The primary objectives are to assess the additive or alternative impact of this staged approach on motivation for abstinence, emotional regulation, and craving reduction. Secondary objectives include examining participant adherence and acceptability of the protocol, as well as exploring the feasibility of integrating 3i as an alternative or adjunct to standard care in rehabilitation settings. |