| CTRI Number |
CTRI/2017/08/009505 [Registered on: 28/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to look at the use of yoga as a treatment in patients with mental illness (schizophrenia). |
|
Scientific Title of Study
|
Examination of therapeutic efficacy and potential mechanisms of yoga treatment in schizophrenia
|
| Trial Acronym |
Yoga-Schiz-multicentric-study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naren P Rao |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental health and neurosciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental health and neurosciences (NIMHANS)
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448342379 |
| Fax |
|
| Email |
narenrao@nimhans.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naren P Rao |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental health and neurosciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental health and neurosciences (NIMHANS)
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448342379 |
| Fax |
|
| Email |
narenrao@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naren P Rao |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental health and neurosciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental health and neurosciences (NIMHANS)
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448342379 |
| Fax |
|
| Email |
narenrao@nimhans.ac.in |
|
|
Source of Monetary or Material Support
|
| Government of India ,
Ministry Of Science and Technology,
Department of Science and Technology
Technology Bhavan, New Delhi- 110016
|
|
|
Primary Sponsor
|
| Name |
Department of science and technology |
| Address |
Ministry Of Science and Technology, Department of Science and Technology Technology Bhavan, New Delhi- 110016 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naren Rao |
National Institute of Mental Health and Neurosciences |
Room#1, Project wing,Under psychiatry observation general ward, Hosur Road, Lakkasandra, Wilson Garden, Bengaluru, Karnataka 560029
Bangalore
KARNATAKA |
944834279
narenrao@nimhans.ac.in |
| Dr R Padmavati |
SCARF (Schizophrenia Research Foundation ,India) |
R/7A, North Main Road,
Anna nagar West Extension
Chennai 600101
Tamilnadu, India
Chennai
TAMIL NADU |
91-4426153971
padmavati@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics committee of SCARF |
Approved |
| NIMHANS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Schizophrenia , (1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Yoga therapy for Schizophrenia |
A validated yoga module for
schizophrenia (Govindaraj et al.
Int Rev Psychiatry. 2016
Jun;28(3):323-326) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Schizophrenia Subject 1)ICD 10diagnosisof schizophrenia 2) capacity to provide informed consent 3)no other current comorbid axis I diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning
Healthy volunteers:​1) Males and females between 18 and 45 years
2)Capacity to provide informed consent
3) absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for both Patients and controls
1)Other current comorbid axis I diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning
2) History of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine)
3)Past history of head injury resulting in loss of consciousness or neurosurgery
4)Concomitant severe medical conditions
5)Change in dose of antipsychotic medication or Electroconvulsive therapy in the past 6weeks 6)Pregnant or lactating |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Negative symptoms of schizophrenia |
6 weeks of intervention
12 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in positive symptoms of schizophrenia
Improvement in cognitive functions
Changes in brain activation measured using fMRI |
6 weeks and 12 weeks of intervention (for positive symptoms and cognitive functions)
12 weeks of intervention for fMRI |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/01/2017 |
| Date of Study Completion (India) |
01/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/03/2020 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under preparation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The goals of this study is to examine whether yoga is efficacious as an add-on treatment in patients with schizophrenia in a randomised multi-centric trial. We would recruit 250 patients over a period of 3 years. Consenting subjects will be randomized to yoga therapy or wait-list control group. Those who are randomized to yoga will receive 12 weeks of yoga. Those who are randomized to wait-list control group will receive yoga after 12 weeks of waiting period. Standardized clinical assessments will be conducted by trained individuals to examine the changes in symptoms of schizophrenia. A subset of subjects will also undergo fMRI scans at baseline and after 12 weeks of intervention. All subjects will undergo uniform assessments at baseline and after 12 weeks. Those who are in waitlist control group will also undergo repeat assessment at the end of 24 weeks. The effect of yoga treatment compared to waitlist control group will be analysed to see the effect of yoga on symptoms of schizophrenia.
|