CTRI/2024/12/077761
Not yet recruiting
Phase 2/3
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Brahmi (Bacopa monniera) Ghana Vati with Alprazolam as an Anxiolytic in Preanesthetic Management.
Dr Anjali Kolte1 site in 1 country70 target enrollmentStarted: February 3, 2025Last updated:
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Dr Anjali Kolte
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To study the role of Bramhi Ghana Vati as anxiolytic in pre-anaesthetic management.
Overview
Brief Summary
A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Brahmi (Bacopa monnieri) Ghana Vati with Alprazolam as an Anxiolytic in Preanesthetic Management. 70 patients with pre-operative anxiety will be treated by Brahmi Ghana Vati and Tablet Alprazolam on the previous night of surgery. Follow-up of the patient will be taken 12 hours after the administration of the medicine and just before the surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients who are undergoing elective surgery and are admitted atleast one day before the scheduled surgical procedure.
Exclusion Criteria
- •Patients with known cases of neurological diseases.
Outcomes
Primary Outcomes
To study the role of Bramhi Ghana Vati as anxiolytic in pre-anaesthetic management.
Time Frame: Assessment will be done on following interval | 1. On previous night of surgery | 2. 12 hours after administration of drug | 3. Just before the surgery
Secondary Outcomes
- To study adverse effects if any(First dose of Brahmi Ghana Vati will be given to patient on previous night of surgery and assessment will be done on following interval)
Investigators
Dr Anjali Kolte
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri
Study Sites (1)
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