FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/01/030840 [Registered on: 29/01/2021] Trial Registered Prospectively
Last Modified On: 28/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Different Yoga Techniques on various Symptoms of Schizophrenia, a psychotic illness 
Scientific Title of Study   Efficacy of Different Yoga Techniques on Negative and Cognitive Symptoms of Schizophrenia - A Comparative Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rama Reddy Karri 
Designation  Part time Ph.D. Scholar 
Affiliation  Sri Balaji Vidyapeeth Deemed University 
Address  Centre for Yoga Therapy, Research & Education (CYTER), 1st Floor, I-Block, Sri Balaji Vidyapeeth Deemed University Pillayarkuppam Pondicherry

Pondicherry
PONDICHERRY
607 402
India 
Phone  9885069777  
Fax    
Email  ramareddykarri@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ananda Balayogi Bhavanani 
Designation  Professor and Director 
Affiliation  Sri Balaji Vidyapeeth Deemed University 
Address  Centre for Yoga Therapy, Education & Research (CYTER) Sri Balaji Vidyapeeth Deemed University Pillayarkuppam Pondicherry

Pondicherry
PONDICHERRY
607 402
India 
Phone  9842311433  
Fax    
Email  yognat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rama Reddy Karri 
Designation  Part time Ph.D. Scholar 
Affiliation  Sri Balaji Vidyapeeth Deemed University 
Address  Centre for Yoga Therapy, Education & Research (CYTER), 1st Floor, I-Block, Sri Balaji Vidyapeeth Deemed University Pillayarkuppam Pondicherry

Pondicherry
PONDICHERRY
607 402
India 
Phone  9885069777  
Fax    
Email  ramareddykarri@rediffmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Sri Balaji Vidyapeeth 
Address  Sri Balaji Vidyapeeth Pillayarkuppam Pondicherry - 607402 
Type of Sponsor  Other [Deemed University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rama Reddy Karri  Manasa Hospital  Psychiatry Department Manasa Hospital Prakasam nagar Rajamahendravaram 533103
East Godavari
ANDHRA PRADESH 		 9885069777

ramareddykarri@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee GSL Medical College General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo Control  Aerobic Exercises 
Intervention  Yoga Techniques  S1 Surya Namaskaras with Beeja mantras group P1 Pranayama - Chandrabedhi group P2 Pranayama - Suryabedhi group P3 Pranayama - Pranava group M1 Meditation - Omkara Dhyana group M2 Meditation - Internal Thrataka group M3 Meditation - External Thrataka group A1 Asanas - Savasana and Yoga Nidra group A2 Asanas - Assorted 5 Asanas group T Kriya – Thoppukaranam  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a) Chronic schizophrenia with more than two years duration
b) On the same minimal maintenance dose of a single antipsychotic drug during the last six months
c) Yoga-naïve or not practised any yoga technique during the last one year
d) Informed consent of the persons and their accompanying persons
 
 
ExclusionCriteria 
Details  a) Physical disabilities or health problems which may interfere with the practice of any type of Yoga technique
b) Religious or cultural factors which are likely to interfere with the practice
c) Regular practitioners of yoga
d) Those who are undertaking special training for improving psychological skills
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. SANS score for Negative symptoms
2. BACS score for cognitive symptoms 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/02/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be provided on request, if the request is ethcal

  6. For how long will this data be available start date provided 31-12-2021 and end date provided 31-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Trial not started, as the registration procedure is not complete yet and hence no prior publications.

Brief Summary:

 

Efficacy of Different Yoga Techniques on Negative & Cognitive Symptoms of Schizophrenia – A Comparative Evaluation

Yoga is a powerful active lifestyle practice. This ancient practice is known to improve and regulate one’s well-being in all dimensions including physical, psychological, social and spiritual. Although there are ancient texts on Hatha Yoga and meditation elaborating the uses of various techniques for wellness promotion, establishing the scientific perspectives is a recent phenomenon. More and more medical professionals have taken up the science of yoga to their heart and dedicated their lives for the propagation of this discipline. Colleges and universities of modern medicine are encouraging the development of Yoga science and therapy by establishing the centres of excellence in yoga and integrating with the core disciplines. The research works of the modern scientific yogacharyas resulted in breaking the communication barriers and building the bridge between esoteric wisdom and evidence-based medical science.

Schizophrenia is one of the important major psychiatric illnesses. Distinct from organic brain syndromes, schizophrenia finds its prominent place along with Bipolar disorders in the hitherto designated functional psychoses. Decades of work has established the genetic and biochemical nature of schizophrenia. Hence it is no more a functional psychosis, but a complex syndrome of bio-psycho-social origin. Even the diagnosis of schizophrenia is based not on any physical parameter but on phenomenology. DSM-5 has laid down certain criteria for systematising research diagnosis.

            Clinical features of schizophrenia include Positive symptoms and Negative symptoms. Positive symptoms are those symptoms, which are not originally part of the personality but added to the mental status or behaviour because of schizophrenia. Those are hallucinations, delusions, disorganised thought process, bizarre behaviour including excitement, grandiosity, hostility and paranoid features. Negative symptoms are the result of the diminution of existing normal mental faculties. These are blunted affect, emotional withdrawal, poor rapport, social isolation, alogia, loss of abstraction and stereotyped thinking. Although schizophrenia is primarily not a disorder of Cognitive functions like orientation and memory, subtle changes in cognition are noticed in persons with chronic schizophrenia.

Advances in pharmacotherapy resulted in the identification of various biochemical receptors and their modulation. Except for Clozapine, all other antipsychotic drugs have almost equal efficacy. The variations exist in their side-effect profiles and pharmacokinetics. Among dozens of molecules in usage, no single molecule is known to alleviate the negative symptoms or improve cognitive symptoms completely.

            The recent scientific research on yoga provides empirical evidence that certain yoga practices are beneficial for the negative and cognitive symptoms of schizophrenia. Yoga consists of certain postures (asanas) including Suryanamaskaras, regulated breathing techniques (pranayamas), hand poses (mudras), purificatory practices (kriyas) and meditation.  There is experiential knowledge on which techniques are appropriate for different physiological and psychological functions.

Among many issues studied on the impact of yoga practice, some are positive promotional issues like improvement of cognitive, sensorimotor and affective skills.4  Some of the personal, family and societal expectations of persons with schizophrenia are likely to be met by yoga techniques. The research problem is to find whether any of the Yoga techniques improve these functions more than a placebo.

The study aims to examine the influence of Yoga techniques on the negative, and cognitive symptoms of persons with Chronic Schizophrenia

Objectives

 Effect of Yoga Techniques on Negative symptoms & Cognitive Symptoms

1 Effect of Surya Namaskaras

2 Effect of Pranayama

 3 Effect of Asanas

4 Effect of Om Japa

5 Effect of Relaxation techniques

6.Effect of a Control group

 

Methodology

Rajamahendravaram is a B class city in Andhra Pradesh. Manasa hospital here is the first private psychiatric hospital for the neighbouring four districts, established in 1980. More than 1,38,000 new psychiatric cases and ten times that number of old or follow-up cases are treated during these 40 years. This hospital is a Janatha hospital meant for treating middle-class people. On average, ten new cases and  90 old cases per day are seen as outpatients, in addition to the in-patients of the hospital licensed for 50 beds. Among the follow-up cases, 20-30 are medication stabilised chronic schizophrenia cases, who come for a follow-up once in 3months.

 Sampling Design

Persons with Chronic schizophrenia who are the clientele of Manasa hospital and stabilised with medication is the universe of the study. Those who attend the hospital for follow-up during the study recruitment period of three months are considered for the study.

The sample size expected is to be between 500 - 1000.

The sample is divided into six  groups

 

 Tools to be used for measuring the outcomes

1.      D.S.M -5, for diagnosis of schizophrenia.

Diagnostic and Statistical Manual, 5th edition is the publication of the American Psychiatric Association, with worldwide recognition for its research utility.

2.       SANS

The Scale for the Assessment of Negative Symptoms (SANS) is the gold standard for assessing the negative symptoms of a person with schizophrenia. It is a 25 item scale with 0-5 grades on a Likert scale.

It does not consume more than 25 minutes, and the rater should be preferably a psychiatrist or psychologist, who is given the training to interview.

3.       BACS  for testing cognitive functions among persons with schizophrenia

Brief Assessment of Cognition in Schizophrenia. A valid and reliable standardised tool for assessing cognitive functions. The test includes Verbal memory ( List learning),.

Working memory  (Digit sequencing task, motor speed), Verbal fluency (Category instances and  Controlled oral word association test.), Attention and speed of information processing (Symbol coding) and Executive functions  (Tower of London)

(Expert opinion is required to choose OSCAR or TRENDS for testing social cognition in place or in addition to BACS)

4.       MMSE  for assessment of  gross cognitive functions in general

Mini-Mental State Examination is a simple tool, which could be used to screen out persons with gross cognitive deficits (i.e. Dementias) and also for assessing the finer deficits in schizophrenia.

 

Men,  and Material

1. Necessary clearance from the Research Ethics committee of nearby GSL medical college, where one of the co-guides is HOD of psychiatry.

2. The Rating Scales are to be translated into Telugu, where necessary and feasible and cross-validated

3. Proformas, checklists and schedules are printed.

4. Sampling Frame is decided.

5. Fifteen Yoga instructors and 15volunteers are recruited from Pranava Yoga Sankalpa Samithi and Friends Service Society. Four psychologists of Manasa hospital are engaged for assessments.

All the cases attending the hospital for follow-up with a stabilised minimum antipsychotic drug are screened for the fulfilment of DSM, inclusion and exclusion criteria. This is done by the psychiatrist.

As all the cases attending OPD during the study period are considered for the study, the question of sampling does not arise for selection.

For allocation of the intervention arm, Cluster random sampling  (Block design) will be followed

All the cases registered for study on Monday are taken for Treatment A; Those registered for study on Tuesday are allotted to Treatment B and so on.

6. Pre-intervention assessments of Negative symptoms and cognitive functions are done for all the groups by the psychologists.

7. Appropriate Interventions are taught to the individual of that appropriate assigned group and video sessions, lasting for 30 minutes each on alternate days is continued for three months. The control group is given 30 minutes of placebo exercise on alternate days for three months.

8. Post-intervention assessments are done on the follow-up day after 90 days, but within 100 days

 Statistical Design

1 Descriptive statistics for classification and presentation of the demographic characteristics

2. Inferential statistics for comparison of the effect of different Yogic interventions compared to placebo using parametric tests like t-test or ANOVA.

Correlation of the effect of different interventions with one another is measured through Karl Pearson’s coefficient test.

 Significance of the proposed research and the expected outcome.

1. The usefulness of Yoga Techniques for the improvement of persons with chronic schizophrenia, in various spheres, viz., negative symptoms and cognitive functions is elicited.

2. The relative importance of one technique over the other is investigated.

 3. This research may unearth unanticipated practical difficulties in incorporating yoga in the psychiatric treatment modules. 

 4. The implementation of yoga in the departments of Psychiatry will have far-reaching implications not only for the individuals but also for society as a whole.

 


 
Close