| CTRI Number |
CTRI/2019/06/019583 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Role of Yoga in Alcohol de-addiction |
|
Scientific Title of Study
|
Effect of Adjuvant Yoga Therapy on Psychological Parameters in Participants of an Alcohol De-addiction program |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiaan Gupta |
| Designation |
MPhil Yoga Therapy Student |
| Affiliation |
CYTER, Sri Balaji Vidyapeeth University |
| Address |
CYTER, Sri Balaji Vidyapeeth University,
Pillayarkuppam, Pondicherry
607402, India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940823948 |
| Fax |
|
| Email |
kiaangupta1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananda Balayogi Bhavanani |
| Designation |
Director |
| Affiliation |
CYTER, SBV |
| Address |
CYTER, Sri Balaji Vidyapeeth University,
Pillayarkuppam, Pondicherry
607402, India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9842311433 |
| Fax |
|
| Email |
yoga@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kiaan Gupta |
| Designation |
MPhil Yoga Therapy Student |
| Affiliation |
CYTER, Sri Balaji Vidyapeeth University |
| Address |
CYTER, Sri Balaji Vidyapeeth University,
Pillayarkuppam, Pondicherry
607402, India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940823948 |
| Fax |
|
| Email |
kiaangupta1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kiaan Gupta, CYTER,
"I" Block, MGMCRI Hospital, Pillayarkuppam, Puducherry 607403 |
| Sri Balaji Vidyapeeth, MGMCRI,
Pondy Cuddalore Main Road, Pillayarkuppam,
National Highway 45A, Puducherry - 607402 |
|
|
Primary Sponsor
|
| Name |
CYTER of Sri Balaji Vidyapeeth |
| Address |
CYTER, Sri Balaji Vidyapeeth University, Pillayarkuppam, POndicherry - 607402 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self |
CYTER, Sri Balaji Vidyapeeth University, Pillayarkuppam, POndicherry - 607402 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kiaan Gupta |
CYTER |
Pathanjali Yogasala, I Block, 1st floor, MGMCRI Hospital, Pillayarkuppam, Puducherry - 607403
Pondicherry
PONDICHERRY |
9940823948
kiaangupta1@gmail.com |
| Kiaan Gupta |
Mahatma Gandhi Medical College and Research Institute |
Room No. 13, Seminar Hall, Department of Psychiatry,
F Block,
Pondicherry
PONDICHERRY |
9940823948
kiaangupta1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga Therapy |
6 sessions, once a week for 6 weeks, along with standard
medical management. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
1. Chronic alcoholic patient, currently in active dependence
2. Willing to participate in Yoga therapy |
|
| ExclusionCriteria |
| Details |
1. Patients manifesting complications of alcoholism such as giddiness, seizures, memory problem preventing them from comprehending the instructions.
2. Patients un-willing to come to Yoga
3. Unable to comprehend and perform the techniques in the protocol |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of Life
(WHOQOL)
Perceived Stress Scale
(PSS)
Hospital Anxiety and
Depression Scale
(HADS)
Alcohol Craving
questionnaire (ACQ)
Beliefs of Yoga Scale
(BAYS) |
6 sessions along with standard
medical management. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2019 |
| Date of Study Completion (India) |
23/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study evaluates effects of adjuvant effect of Yoga therapy on psychological parameters of ADS patients.
Adjuvant Yoga therapy includes Yogic counseling, breath-body co-ordination, static postures (Asanas), breathing techniques (Pranayamas), and relaxation techniques, carefully selected by conducting a detailed literature review and the final Yoga schedule thus arrived was validated by eminent experts in the field of Yoga.
Patients who satisfies the inclusion and exclusion criteria would be randomized to either Yoga or Control group. Randomization would be done using statistics and sample app by Dept. of Psychiatry. Patients in both the groups received standard medical care in the form of individualized drug therapy by Dept. of Psychiatry. Patients in the Yoga group would receive 6 supervised Yoga therapy sessions for 6 weeks. Patients would be followed up rigorously by weekly telephonic conversations. The following parameters would be studied at the baseline and after 6 weeks intervention period.
Quality of Life (WHO-QOL) Perceived Stress Scale (PSS) Hospital Anxiety and Depression Scale (HADS) Alcohol Craving questionnaire (ACQ) Beliefs of Yoga Scale (BAYS)
Pre and post data would be collected and analyzed after completion of the intervention. |