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

â??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 ?.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/050158

Enrollment

Registered

2023-02-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 Î²-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.

Design outcomes

Primary

Measure	Time frame
Changes in Scale for Assessment of Positive Symptoms (SAPS) and Scale for Assessment of Negative Symptoms (SANS).Timepoint: Baseline, after virechana, 45th and 90th day.	—

Secondary

Measure	Time frame
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 Timepoint: Baseline and 90th day.	—

Countries

India

Contacts

Public ContactDr Kishore Kumar R

National Institute of Mental Health and Neurosciences

ayurkishore@yahoo.com9845829174

Outcome results