| CTRI Number |
CTRI/2023/04/051937 [Registered on: 25/04/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on Drug addicts. |
|
Scientific Title of Study
|
COMPARATIVE EFFECT OF YOGIC PRACTICES ON PHYSIOLOGIAL AND PSYCHOLOGICAL VARIABLES OF DRUG ADDICTS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Kumar |
| Designation |
Ph.D. Scholar |
| Affiliation |
|
| Address |
Department of Yogic Sciences, Lakshmibai National Institute of Physical Education, Shakti Nagar, Mela Road, Gwalior - 474002 (M.P.)
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9882876059 |
| Fax |
|
| Email |
shubhamkumarhpu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Sahu |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Physical Education Pedagogy,Lakshmibai National Institute of Physical Education, Shakti Nagar, Mela Road, Gwalior - 474002 (M.P.)
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9691845810 |
| Fax |
|
| Email |
msahu@lnipe.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Kumar |
| Designation |
Ph.D. Scholar |
| Affiliation |
|
| Address |
Department of Yogic Sciences,Lakshmibai National Institute of Physical Education, Shakti Nagar, Mela Road, Gwalior - 474002 (M.P.)
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9882876059 |
| Fax |
|
| Email |
shubhamkumarhpu@gmail.com |
|
|
Source of Monetary or Material Support
|
| University Grants Commission (UGC) Bahadur Shah Zafar Marg,
New Delhi - 110002. |
|
|
Primary Sponsor
|
| Name |
Dr. Manoj Sahu |
| Address |
Department of Physical Education Pedagogy, LNIPE Campus, Mela Road Gwalior - 474002 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rohit |
Sneh Love Care Rehabilitation Center |
Building name - Dipesh bhandary building, C/o Sunarghati, Matiana, Shimla. (department/division/room number - not applicable in this case).
Shimla
HIMACHAL PRADESH |
7807129625
snehloveandcare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Sneh Love Care Rehabilitation Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F111||Opioid abuse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMPARATIVE EFFECT OF YOGIC PRACTICES ON PHYSIOLOGIAL AND
PSYCHOLOGICAL VARIABLES OF DRUG ADDICTS |
The purpose of the study is to analyse the effects of selected yogic practices on the
physiological, and psychological variables of the drug addicts.
For this purpose, the total 60 persons are selected randomly from the rehabilitation
center, Shimla (Himachal Pradesh). The selected 60 persons are goes under the drug
rehabilitation process for the minimum duration of 7-8 months. The subjects are from a wide
range of age group i.e., between 25-50. Out of the sample of 60, they can be further divided
into four groups i.e., experimental group1 (asana group), experimental group2 (pranayama
group), experimental group3 (asana and pranayama group), Non-experimental group (control
group).
The selected addicts were substance abuser of drugs namely - Heroin, corax, Bentium5, Alcohol etc. The total duration of the yoga intervention is 12 weeks. |
| Intervention |
EFFECT OF YOGIC PRACTICES ON PHYSIOLOGIAL VARIABLES OF DRUG ADDICTS |
The purpose of the study is to analyze the effects of selected yogic practices on the physiological variables of drug addicts. |
| Intervention |
EFFECT OF YOGIC PRACTICES ON PSYCHOLOGICAL VARIABLES OF DRUG ADDICTS |
The purpose of the study is to analyze the effects of selected yogic practices on the psychological variables of drug addicts. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1)The study will be delimited to the male subjects.
2) The study age ranging between 25-50.
3) The study will be delimited to the selected yogic practices. |
|
| ExclusionCriteria |
| Details |
1) This Study will be excluded female subjects.
2) Those who are taking only one type of drug in the past are excluded from this study.
3) Those persons who are not mentally able to do yoga are excluded from this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Psychological Variables
1. Happiness
2. Self-esteem
Physiological variables
1. Body Mass Index (BMI)
2. Heart Rate
3. Blood Pressure
• Systolic Blood Pressure
• Diastolic Blood Pressure |
The total duration of the yoga intervention is 12 weeks. The data will be collected before
and after the yoga intervention and also collected after the 6 weeks of duration. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/04/2023 |
| 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="0"
Months="2"
Days="24" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
There is no publication pertain yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of the study is to analyse the effects of selected yogic practices on the
physiological, and psychological variables of the drug addicts. For this purpose, the total 60 persons are selected randomly from the rehabilitation
center, Shimla (Himachal Pradesh). The selected 60 persons are goes under the drug
rehabilitation process for the minimum duration of 7-8 months. The subjects are from a wide
range of age group i.e., between 25-50. Out of the sample of 60, they can be further divided
into four groups i.e., experimental group1 (asana group), experimental group2 (pranayama
group), experimental group3 (asana and pranayama group), Non-experimental group (control
group). The total duration of the yoga intervention is 12 weeks. The data will be collected before
and after the yoga intervention and also collected after the 6 weeks of duration. The training
would be given to the subjects three days per week. Every training session would be of 30
minutes. The exercises would include proper positioning, retaining and relaxation phases
according to the capability of the subjects.
STATSTICAL TECHNIQUE 1. To characterize the level of Psychological and Physiological Variables of Asana,
Pranayama, Asana + Pranayama and Control Group of Drug Addict Persons of Himachal
Pradesh State. Descriptive Statistics will be used. 2. To compare pre-test post-test mean scores Psychological and Physiological Variables
Asana, Pranayama, Asana + Pranayama and Control Group of Drug Addict Persons of
Himachal Pradesh State. Dependent T- test will be used. 3. To compare adjusted mean scores of Psychological and Physiological Variables of
Asana, Pranayama, Asana + Pranayama and Control Group of Drug Addict Persons of
Himachal Pradesh State by considering their pre-Psychological and Physiological
Variables as covariate. ANCOVA will be used. 4. Level of significance will be set as 0.05 |