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A clinical study to compare the efficacy of add-on Ayurveda treatment versus Allopathy treatment in Alzheimerâ??s dementia

Integrative Ayurveda Rasayana and Yoga therapeutic regimen as on Add-on to conventional management of Mild-Moderate Alzheimerâ??s disease: 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/2024/12/077811
Enrollment
60
Registered
2024-12-06
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: G30- Alzheimers disease

Interventions

None listed

Sponsors

Ministry of AYUSH, Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Montreal Cognitive Assessment (MoCA) score of 13â??23, mild to moderate severity (DSM-5). 2. Patients of age group 50-80 years of either sex. 3. Educational level above 7th standard with a family member or informal career. 4. Right handedness.

Exclusion criteria

Exclusion criteria: 1. Patients with severe dementia, known neuropsychiatric conditions, dependence of any psychoactive substances and evidences of malignancy. 2. Patients with uncontrolled endocrinological disturbances, hypertension or other systemic illness. 3. Patients with other neurodegenerative disorders like Lewy body dementia, Fronto-temporal Dementia. 4. Patients with uncontrolled Type 2 Diabetes mellitus 5. Patients on β-blockers, thiazide diuretics, corticosteroids, HRT. 6. Patients with Uncontrolled Blood pressure. 7. Patients with concurrent Hepatic Dysfunction 8. Patients with Renal Dysfunction Patients with severe Pulmonary Dysfunction 9. Patients with evidence of malignancy 10. Patients suffering from major systemic illness necessitating long-term drug treatment. 11. Patients who have completed participation in any other clinical trial during the past six (06) months. 12. Left-handedness 13. Education level is less than 8th grade.

Design outcomes

Primary

MeasureTime frame
Changes in NIMHANS Neuropsychological Battery for Elderly (NIMHANS NPBE) and Clinical Dementia Rating Scale (CDRS)Timepoint: Baseline and 90th day

Secondary

MeasureTime frame
1. Changes in functional Magnetic Resonance Imaging (fMRI) 2. Changes in Herat Rate Variability (HRV). 3. Changes in Neuro gut biomarkers 4. 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.com09845829174

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026