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Effects of Brahmi Ghrita on Cognitive Function in breast cancer patients on adjuvant chemotherapy: A randomized controlled trial

Effect of Ayurvedic Nootropics On Cognitive Function in Breast Cancer patients on Adjuvant Chemotherapy A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025295
Enrollment
120
Registered
2020-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Brahmi ghrita: Brahmi ghrita intervention will be given and the patients which will be randomized into 3 arms, one arm will receive a formulation named Brahmi Ghrita, 2nd arm will rece

Sponsors

Department of AYUSH Extramural Research Scheme Govt of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Early stage II and III breast cancer patients 2. Age between 18 to 75 years 3. Scheduled to undergo at least 6 cycles of adjuvant chemotherapy followed by adjuvant radiotherapy at HCG hospital. 4. High school education with ability to read and write English

Exclusion criteria

Exclusion criteria: 1. Those with prior h/o depression, major psychiatric illness and Alzheimerâ??s disease and on medication 2. Those with brain metastases 3. Concurrent medical condition likely to influence survival 4. Uncontrolled diabetes, hypertension and autoimmune disease 5. Neurological disorders such as any significant head injury, epilepsy, Parkinsonâ??s disease, neurodegenerative disorders etc. 6. Regular participation in an active behavioral intervention/Ayurveda Nootropic in the last six months 7. H/o recent infections or fever in the past two weeks 8. Those with anemia (Hemoglobin 9. Those with cardiac pacemakers or other incompatible body implants (For f MRI study) 10. Left handedness or mixed handedness 11. Claustrophobia

Design outcomes

Primary

MeasureTime frame
improvement in Cognitive Function will be assessed through Neuropsychological test battery For a subset of 20 patients task based fMRI will be done Timepoint: Baseline assessment soon after the diagnosis 2nd assessment after completion of chemotherapy 3rd assessment after completion of the Intervention (i.e after 3 months of intervention)

Secondary

MeasureTime frame
1. Quality of life 2. FACT COG 3. Quality of Life as measured by self-report EORTC QOL C30 4. Stress as measured by Self-report Perceived Stress Scale 5.Heart rate variabilityTimepoint: Baseline assessment soon after the diagnosis 2nd assessment after completion of chemotherapy 3rd assessment after completion of the Intervention (i.e after 3 months of intervention)

Countries

India

Contacts

Public ContactDr Swathi B H

state private university

ashwini.g@tdu.edu.in9845778548

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026