Effects of Brahmi Ghrita on Cognitive Function in breast cancer patients on adjuvant chemotherapy: A randomized controlled trial
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2020/05/025295
- Lead Sponsor
- Department of AYUSH Extramural Research Scheme Govt of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 10gm %)
9. Those with cardiac pacemakers or other incompatible body implants (For f MRI
study)
10. Left handedness or mixed handedness
11. Claustrophobia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method improvement in Cognitive Function will be assessed through Neuropsychological test battery <br/ ><br>For a subset of 20 patients task based fMRI will be done <br/ ><br>Timepoint: Baseline assessment soon after the diagnosis <br/ ><br>2nd assessment after completion of chemotherapy <br/ ><br>3rd assessment after completion of the Intervention (i.e after 3 months of intervention)
- Secondary Outcome Measures
Name Time Method 1. Quality of life <br/ ><br>2. FACT COG <br/ ><br>3. Quality of Life as measured by self-report EORTC QOL C30 <br/ ><br>4. Stress as measured by Self-report Perceived Stress Scale <br/ ><br>5.Heart rate variabilityTimepoint: Baseline assessment soon after the diagnosis <br/ ><br>2nd assessment after completion of chemotherapy <br/ ><br>3rd assessment after completion of the Intervention (i.e after 3 months of intervention)