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CTRI Number  CTRI/2024/11/077005 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 26/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical observational study to understand the effect of Virechana Karma on Vagal tone, Gut Microbiota, and Metabolic parameters in schizophrenia. 
Scientific Title of Study   Effect of Virechana Karma on vagal tone, gut Microbiota, and metabolic parameters in schizophrenia: A clinical observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sangeeta S 
Designation  PhD Scholar/Senior Research Fellow 
Affiliation  NIMHANS 
Address  Dept. of Integrative Medicine, NIMHANS, Bangalore, Karnataka.

Bangalore
KARNATAKA
560029
India 
Phone  8700975979  
Fax    
Email  drsangeetasatish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Kishore Kumar R 
Designation  Professor & Head 
Affiliation  NIMHANS 
Address  Dept. of Integrative Medicine, NIMHANS, Bangalore, Karnataka.

Bangalore
KARNATAKA
560029
India 
Phone  9845829174  
Fax    
Email  ayurkishore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kishore Kumar R 
Designation  Professor & HoD 
Affiliation  NIMHANS 
Address  Dept. of Integrative Medicine, NIMHANS, Bangalore, Karnataka.

Bangalore
KARNATAKA
560029
India 
Phone  9845829174  
Fax    
Email  ayurkishore@gmail.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH, Government of India, AYUSH Bhavan, GPO Complex, B Block, Barapullah Rd, INA Colony, New Delhi, Delhi 110023 
 
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 Sangeeta S  NIMHANS  Dept. of Integrative Medicine, NIMHANS, Bangalore, Karnataka,
Bangalore
KARNATAKA 		 08700975979

drsangeetasatish@gmail.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:F200||Paranoid schizophrenia. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charaka samhita, Procedure details: Virechana medicine will be given between 8am -9 am as per the climate. Proper poorva kamra & paschata karma rules will be follwed during the whole procedure.)
(1) Medicine Name: Trivrith lehyam, Reference: Ashtanga hridayam Kalpa stanam 2/9, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Schizophrenia
Subjects will be diagnosed based on Diagnostic criteria of Schizophrenia according to
DSM-5 as well as Ayurvedic Diagnosis of Unmada. Patients with treatment resistance
symptoms and predominantly having cognitive symptoms with stable medications for
at least 1 month will be recruited.
Inclusion criteria
1. Diagnosed patients of Unmada according to Ayurveda and Patients of Schizophrenia
spectrum disorders as per DSM-5.
2. Schizophrenia patients on treatment with antipsychotics (except clozapine) and on
stable medication for at least six weeks
3. Persistence of moderate or greater severity of positive or negative symptoms as
assessed with SAPS and SANS ( ≥ 3 severity of SAPS (Item numbers 7, 20, 25, 34) and
SANS (Item numbers (7, 13, 17, 22).
4. Subjects between 18 years and 45 years of age.
5. Patients who are on stable medications at least for a month.
Healthy Controls
Inclusion criteria
1. Age range: 18 – 45 years
2. Both sexes
3. Ready to sign the informed consent form. 
 
ExclusionCriteria 
Details  Schizophrenia
Exclusion criteria
1. Patients with psychosis other than schizophrenia, neurotic disorders like anxiety,
OCD, substance use disorders, major systemic illness, neurological disorders and
immune system disorders
2. Patients treated with any antibiotics or Probiotic/Prebiotic agents in the previous
month;
3. Patients with suicidal tendencies
4. Pregnant and lactating mothers
5. Patients Unsuitable (Subjects suffering from Diarrhea, rectal bleeding, hematuria,
vaginal bleeding, flatulence, acute fever, acute rhinitis, any injury to rectum,
children, pregnant women, Low/High BMI, subjects undergoing Basti therapy.) for
Virechana procedure.
6. Patients with uncontrolled Diabetes mellitus, Hypertension, severe Hepatic Renal
and Pulmonary Dysfunction.
Healthy Controls
Exclusion criteria
1. Diagnosis of any psychiatric or neurological disorder
2. Family history of psychiatric or neurological disorder in any of the first-degree
relatives
3. Any immune disorder or medical disorder interfering with the research.
4. Patients treated with any antibiotics or Probiotic/Prebiotic agents in the previous
month; 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OUTCOME MEASURES
• The changes in Vagal tone using HRV & Electrogastrography in subjects diagnosed
with Schizophrenia, before & after Virechana karma.
• The changes in gut microbiota in subjects diagnosed with Schizophrenia before &
after Virechana karma. 		 Before Deepana Pachana (T0), before Virechana (T1), and after Virechana
Karma (T2).. 
 
Secondary Outcome  
Outcome  TimePoints 
1. The changes in Liver Function Test, Lipid profile and Sr. Electrolytes, before & after
Virechana karma.
2. The changes in
• BPRS, CGI, SANS & SAPS – for Patients diagnosed with Schizophrenia before &
after Virechana karma.
• GSRS- Gastrointestinal Symptom Rating Scale
• WHO-QOL (Brief) &
• Perceived Stress scale 		 Before Deepana Pachana (T0), and after Virechana
Karma (T2). 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   01/12/2024 
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="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study aims to assess the effects of Virechana Karma, (which is one among the 5 Panchakarma procedures), on vagal tone, gut microbiota composition, and biochemical markers in individuals with Schizophrenia. Virechana Karma involves three stages: Poorvakarma (preparatory phase), Pradhanakarma (main purgation), and Samsarjana Krama (post-therapy recovery). The study adopts a longitudinal design with two arms: a case-control baseline comparison and a pre- and post-intervention analysis. Participants will be divided into two groups: schizophrenia (SCZ), and healthy controls (HC). The SCZ group will undergo a 13-25 day Virechana Karma regimen involving Deepana Pachana (Chitrakadi Vati), Snehapanam (Kalyanakaghrita), and Virechana with Trivruth Avaleha. Baseline and post-treatment assessments will include heart rate variability (HRV), Electrogastrography (EGG), gut microbiota sequencing, liver function tests, lipid profiles, serum electrolytes, and clinical scales such as BPRS, CGI, SANS, SAPS, GSRS, WHO-QOL, PSS. The primary outcomes focus on changes in vagal tone and gut microbiota, while secondary outcomes involve biochemical and clinical parameters. The research also aims to elicit Virechana Karma’s mechanistic potential while improving physiological and mental health in schizophrenia patients.

 
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