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CTRI Number  CTRI/2023/02/050158 [Registered on: 28/02/2023] Trial Registered Prospectively
Last Modified On: 13/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to compare the efficacy of add-on Ayurveda treatment versus Allopathy treatment in Schizophrenia.  
Scientific Title of Study   “Integrative Ayurveda and Yoga therapeutic regimen as on Add-on to conventional management of Schizophrenia: An RCT for evaluation of safety and assessment of Clinical, functional Neuroimaging, Gut biomarkers, autonomic functions, Genomics and Cognitive function parameters”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kishore Kumar R 
Designation  Professor of Ayurveda 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Integrative Medicine National Institute of Mental Health and Neurosciences Hosur Road Bengaluru.

Bangalore
KARNATAKA
560029
India 
Phone  9845829174  
Fax    
Email  ayurkishore@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishore Kumar R 
Designation  Professor of Ayurveda 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Integrative Medicine National Institute of Mental Health and Neurosciences Hosur Road Bengaluru.


KARNATAKA
560029
India 
Phone  9845829174  
Fax    
Email  ayurkishore@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kishore Kumar R 
Designation  Professor of Ayurveda 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Integrative Medicine National Institute of Mental Health and Neurosciences Hosur Road Bengaluru.


KARNATAKA
560029
India 
Phone  9845829174  
Fax    
Email  ayurkishore@yahoo.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH, Government of India 
 
Primary Sponsor  
Name  Ministry of AYUSH, Government of India 
Address  AYUSH Bhavan, GPO Complex, B Block, Barapullah Rd, INA Colony, New Delhi, Delhi 110023 
Type of Sponsor  Government funding agency 
 
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 Kishore Kumar R  National Institute of Mental health and Neurosciences  Department of Psychiatry and Department of Integrative Medicine NIMHANS, Hosur Main Road, Bengaluru 560029 Bangalore KARNATAKA.
Bangalore
KARNATAKA 		 09845829174

ayurkishore@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee for Research in AYUSH and Integrative Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F20||Schizophrenia. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charaka Samhita, Procedure details: Deepana pachana - Chitrakadi vati for 5 days. Snehapana - Kalyanaka Gritha for 3-7 days. Abhyanaga and Sveda with ksheerabala taila for 3 days Virechana with trivrut lehya for one day.)
(1) Medicine Name: Kalyanaka Gritha, Reference: Charaka Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 90 Days
2Comparator Arm (Non Ayurveda)-Antipsychotics Tab. Risperidone orally or Tab. Olanzapine orally or Depot Flupenthixol Intravenous Tab. Trihexyphenidyl (SOS) Tab. Clonazepam (SOS) Dose and frequency: As per the treating psychiatrists. Duration: As per the treating psychiatrists.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Diagnosed patients of Unmada according to Ayurveda.
2. Patients of Schizophrenia spectrum disorders as per DSM-5.
3. Patients who have partially responded to treatment with residual symptoms and predominant cognitive symptoms.
4. Patients on stable medications for at least 8 weeks.
5. Patients of both sexes in the age group of 18 to 60 years, irrespective of socioeconomic status.
6. Patients ready to sign the informed consent form.
7. Right handedness
 
 
ExclusionCriteria 
Details  1. Patients with suicidal tendencies/ thoughts.
2. Patients with psychosis other than schizophrenia
3. Patients with neurotic disorders like Anxiety, OCD, Depression, PTSD.
4. Patients having cardiovascular problems.
5. Patients with neurological disorders such as any significant head injury.
6. Patients with neurodegenerative disorders.
7. Patients of substance use disorders.
8. Pregnant and lactating women.
9. Patients with uncontrolled Type 2 Diabetes mellitus
10. Patients on β-blockers, thiazide diuretics, corticosteroids, HRT.
11. Patients with Uncontrolled Blood pressure.
12. Patients with concurrent Hepatic Dysfunction
13. Patients with Renal Dysfunction Patients with severe Pulmonary Dysfunction
14. Patients with evidence of malignancy
15. Patients suffering from major systemic illness necessitating long-term drug treatment.
16. Patients who have completed participation in any other clinical trial during the past six (06) months.
17. Left-handedness
18. Education level is less than 8th grade.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Scale for Assessment of Positive Symptoms (SAPS) and Scale for Assessment of Negative Symptoms (SANS).   Baseline, after virechana, 45th and 90th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Cognitive function on Brief Cognitive Assessment Tool for Schizophrenia (B-CATS).
Changes in functional Magnetic Resonance Imaging (fMRI) through Attention Network Task (ATN)
Changes in Herat Rate Variability (HRV).
Changes in Neuro gut biomarkers
Changes in Telomere length
 		 Baseline and 90th day. 
 
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   Phase 4 
Date of First Enrollment (India)   03/03/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is a randomized single-blind, parallel-group trial comparing the safety and efficacy of Add-on Ayurveda intervention (Virechana karma followed by Kalyana Gritha for a duration of 90 days) and Conventional treatment Risperidone / Olanzapine / Depot Flupenthixol + Trihexyphenidyl & Clonazepam daily for three months in 60 subjects (30 in each group) with Schizophrenia that will be conducted at National Institute of Mental health and Neurosciences (NIMHANS) Bengaluru. The primary outcome measure will be the Changes in Scale for Assessment of Positive Symptoms (SAPS) and Scale for Assessment of Negative Symptoms (SANS) score at three months. The secondary outcome measures are - Changes in Cognitive function on Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), functional Magnetic Resonance Imaging (fMRI) through Attention Network Task (ATN), Herat Rate Variability (HRV), Neuro gut biomarkers and changes in Telomere length at three months.

 
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