| CTRI Number |
CTRI/2021/11/037826 [Registered on: 08/11/2021] Trial Registered Retrospectively |
| Last Modified On: |
05/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
A study to develop, validate and assess an integrated yoga module used as adjust for the management of Substance Use Disorder. |
|
Scientific Title of Study
|
VALIDATION OF AN INTEGRATED YOGA MODULE AS AN ADJUNCT FOR THE MANAGEMENT OF SUBSTANCE USE DISORDER. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yantra Atmika Ramsahaye Maraz |
| Designation |
PHD student |
| Affiliation |
1.Centre Daccueil de Terre Rouge and 2.SVYASA |
| Address |
Ramphul lane
Mon désir
Vacoas
Mauritius
1.CDATR
Village Hall Lane,
Terre-Rouge
Mauritius
2.SVYASA
Department of Humanities and Yoga
Swami Vivekananda Rd, Kalluballu Post, Anekal, Jigani, Karnataka 560105, India
00230
Other |
| Phone |
0023058238861 |
| Fax |
|
| Email |
atmiks01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Taroonsingh Ramkoosalsingh |
| Designation |
Psychiatrist |
| Affiliation |
Brown Sequard Mental Health Care Centre |
| Address |
Brown Sequard Mental Health Care Centre Beau Bassin, Mauritius
Consultant in Charge Psychiatry
Brown Sequard Mental HealthCare Centre Beau Bassin, Mauritius
00230
Other |
| Phone |
023054975798 |
| Fax |
|
| Email |
vida_86@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Rawat |
| Designation |
Associate Professor |
| Affiliation |
SVYASA |
| Address |
Swami Vivekananda Rd
Kalluballu Post
Anekal
Jigani
Swami Vivekananda Rd
Kalluballu Post
Anekal
Jigani
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
6362805583 |
| Fax |
|
| Email |
vikasrawat@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| S-VYASA
Swami Vivekananda Rd, Kalluballu Post, Anekal, Jigani, Karnataka 560105, India |
|
|
Primary Sponsor
|
| Name |
Yantra Atmika Ramsahaye Maraz |
| Address |
SVYASA
Swami Vivekananda Rd
Kalluballu Post
Anekal
Jigani
Bangalore
India |
| Type of Sponsor |
Other [Self-Funding] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Mauritius |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jose Ah Choon Director |
Centre d Accueil de Terre Rouge (NGO) |
C.A.T.R.
Rue Martin Luther King
Terre-Rouge
Port Louis
Mauritius
|
2487041
2492498
cdadtr@intnet.mu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
| National Ethics Clearance (Ministry of Health, Mauritius) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Substance Use Disorder and Quality of life |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Yoga Module |
Integrated Yoga Module developed for the management of Substance Use Disorder used as adjunct to usual treatment.
3x per week
1.30 duration / session
for 3 months |
| Comparator Agent |
Treatment As Usual |
Treatment As Usual given at the centre which is based on 12-step method and Alcoholics Anonymous method.
for 3 months
24 hr treatment Residential program |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Individuals who have been diagnosed by a Psychiatrist with New Psychoactive Drugs, or Opiates and Opioids or Polysubstance Use /Other Unknown substances dependence.
Individuals who are males above 18-45 years old
Having medical clearance to participate
Individuals who are fluent in either French or Creole or English.
Individuals who have undergone medically supervised detoxification at the CATR rehabilitation center.
|
|
| ExclusionCriteria |
| Details |
1. Individuals who have been diagnosed with psychotic disorders like schizophrenia.
2. Individuals with acute withdrawal symptoms as assessed by a Psychiatrist
3. Individuals with acute suicidality or possibility of being of imminent dangers to others
4. Individuals needing intensive treatment due to high risk of relapse or continued heavy use, as determined by a Psychiatrist |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Development an Integrated Yoga Module for Substance Use Disorder
2. Validation of the Integrated Yoga Module for Substance Use Disorder
3. Parameters at each 3 time point- Changes in symptoms of Substance Use disorder- motivation, overall health and quality of life |
Estimated time :
10.01.22- baseline assessment
5.02.22- 4th week assessment
25.02.22- 8th week assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A pilot testing of the Integrated Yoga Module to assess the feasibility of the module
Secondary outcomes for each 3 assessment period- Assessing the Guna (Vedic personality) and Anthropomorphic Assessment- Respiratory rate, BMI, Brahmari rate, Blood pressure. |
Pre intervention, 4 weeks and 1 month (may vary as per availability of participants)
Tentative dates: 10.01.22- 25.02.21 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study’s objective is to develop, validate and assess the feasibility of an Integrated Yoga Module as an adjunct for the management of substance use disorder. For the development of the module, we are taking support from ancient and modern literature. The validation will be done by following the Delphi method of iteration with international experts in the field of yoga, psychology, psychiatry, social work as well as stake holders. The feasibility of the study will be assessed by doing a pilot study at the Centre d’Accueil de Terre Rouge (Mauritius). The Integrated Yoga Module will be done on an experimental group in addition with the Treatment as Usual. The control group will be given Treatment as Usual. Anthropomorphic details, symptoms of Substance Use Disorder, motivation and quality of life levels will be assessed for both the groups, pre-intervention, post-intervention(4 weeks) and after one month. Changes will be made to the Integrated Yoga Module as per the inputs of participants. |