Clinical study on herbal neutraceuticals in stress management

Phase 2

Active, not recruiting

• Conditions: Generalized anxiety disorder. Ayurveda Condition: UNMADA-PURVARUPAM,

• Registration Number: CTRI/2022/09/045723
• Lead Sponsor: MVR Ayurveda medical college and hospital

Brief Summary

It is a randomized participantblinded, comparative placebo controlled trial, to study the efficacy ofneutraceuticals in stress management. The trial agent will be given in a doseof 3.5 gm with lukewarm water for 14 days. This will be compared with placebogroup. Cortisole level and Hamilton anxiety scoring will be evaluated on beforeand after 14 days. Followup measurements will be taken in 28th day.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-23
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Both the sexes, which fulfills the diagnostic criteria.

Exclusion Criteria

Hypertension, Cardiac disorders, IBD, Herb sensitivity, endocrine disorders, pregnancy and lactation etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood cortisole	before treatment, after 14 days; and followup on 28th day

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating scale	before treatment, after 14 days; and followup on 28th day

Trial Locations

Locations (1)

MVR Ayurveda medical college; 🇮🇳 Kannur, KERALA, India

MVR Ayurveda medical college

🇮🇳Kannur, KERALA, India

Dr Shyam Prasad M

Principal investigator

9496192409

getshyampm@yahoo.co.in