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A clinical study to compare the efficacy of add-on Ayurveda treatment versus Allopathy treatment in Schizophrenia.

Phase 4
Not yet recruiting
Conditions
Schizophrenia. Ayurveda Condition: UNMADAH,
Registration Number
CTRI/2023/02/050158
Lead Sponsor
Ministry of AYUSH, Government of India
Brief Summary

Thisstudy is a randomized single-blind, parallel-group trial comparing the safetyand efficacy of Add-on Ayurveda intervention (Virechana karma followed byKalyana Gritha for a duration of 90 days) and Conventional treatment Risperidone/ Olanzapine / Depot Flupenthixol + Trihexyphenidyl & Clonazepam daily for threemonths in 60 subjects (30 in each group) with Schizophrenia that will beconducted at National Institute of Mental health and Neurosciences (NIMHANS)Bengaluru. The primary outcome measure will be the Changes in Scale forAssessment of Positive Symptoms (SAPS) and Scale for Assessment of NegativeSymptoms (SANS) score at three months. The secondaryoutcome measures are - Changes in Cognitive function on Brief CognitiveAssessment Tool for Schizophrenia (B-CATS), functional Magnetic ResonanceImaging (fMRI) through Attention Network Task (ATN),HeratRate Variability (HRV), Neuro gut biomarkers and changes inTelomere length at three months.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Diagnosed patients of Unmada according to Ayurveda.
  • Patients of Schizophrenia spectrum disorders as per DSM-5.
  • Patients who have partially responded to treatment with residual symptoms and predominant cognitive symptoms.
  • Patients on stable medications for at least 8 weeks.
  • Patients of both sexes in the age group of 18 to 60 years, irrespective of socioeconomic status.
  • Patients ready to sign the informed consent form.
  • Right handedness.
Exclusion Criteria
  • Patients with suicidal tendencies/ thoughts.
  • Patients with psychosis other than schizophrenia 3.
  • Patients with neurotic disorders like Anxiety, OCD, Depression, PTSD.
  • Patients having cardiovascular problems.
  • Patients with neurological disorders such as any significant head injury.
  • Patients with neurodegenerative disorders.
  • Patients of substance use disorders.
  • Pregnant and lactating women.
  • Patients with uncontrolled Type 2 Diabetes mellitus 10.
  • Patients on β-blockers, thiazide diuretics, corticosteroids, HRT.
  • Patients with concurrent Hepatic Dysfunction 13.
  • Patients with Renal Dysfunction Patients with severe Pulmonary Dysfunction 14.
  • Patients suffering from major systemic illness necessitating long-term drug treatment.
  • Patients who have completed participation in any other clinical trial during the past six (06) months.
  • Left-handedness 18.
  • Education level is less than 8th grade.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Measures
NameTimeMethod
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)

Trial Locations

Locations (1)

National Institute of Mental health and Neurosciences

🇮🇳

Bangalore, KARNATAKA, India

National Institute of Mental health and Neurosciences
🇮🇳Bangalore, KARNATAKA, India
Dr Kishore Kumar R
Principal investigator
09845829174
ayurkishore@yahoo.com

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