Difference between effect of Ashwagandha (Withania Somnifera) and Brahmi (Bacopa monnieri Linn) on stress level and quality of sleep in patients experiencing stress.

Phase 3

Not yet recruiting

• Conditions: Somatization disorder. Ayurveda Condition: MANOVAHASROTOVIKARAH,

• Registration Number: CTRI/2023/12/060756
• Lead Sponsor: Dr Mohnish Gokhale

Brief Summary

This study is Double blind randomised controlled trial  comparing theclinical efficacy of Tablet Ashwagandha 500 gm HS and Tablet Brahmi 500 mg HS for 60 days in 60 patients(30 patients in each group) the primaryoutcome will measure by Percieved stress scale (PSS) Montreal Cognitive assesment test Pittersberg sleep quality index (PSQI)  before and after completion of treatment

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-10
• Study Start: 2024-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1 Body mass index 18–29 kg/m2 2 Healthy as determined by medical history physical examination, and clinical judgment of the investigator under perceived stress with a score of 14–24 on the PSS 3 Cognitively sound as confirmed by the Montreal Cognitive Assessment test 4 Willing and able to provide written informed consent and agreed to attend regular follow-ups 5 Patients with controlled NIDDM & HTN.

Exclusion Criteria

1 Pregnant & lactating woman 2 Subjects with an education level below the eighth grade and unable to read 3 Subjects with any severe comorbid medical conditions or any clinically significant systemic disease with significant medication use 4 Subjects with a history of drug dependence alcohol intake or having nicotine or caffeine dependence 5 Night duty people.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lowering of stress level in patients of stress level in subjects experiencing stress	60 Days

Secondary Outcome Measures

Name	Time	Method
Improving of sleep quality	60 Days

Trial Locations

Locations (1)

Mahatama Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatama Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha

🇮🇳Wardha, MAHARASHTRA, India

Dr Mohnish Gokhale

Principal investigator

8668200371

mohnishgokhale76@gmail.com