To check the effect of Menoveda Akira tablet in patients having menopause related mental health issues

Phase 2

Completed

• Conditions: Other specified mental disorders due to known physiological condition. Ayurveda Condition: RAJIKA,

• Registration Number: CTRI/2023/01/049316
• Lead Sponsor: Menoveda Lifesciences Pvt Ltd

Brief Summary

Menopause is the time that marks the end of your menstrual cycles. It’s diagnosed after you’ve gone 12 months without a menstrual period. Menopause can happen in your 40s or 50s, but the average age is 51 in the United States.

Menopause is a natural biological process. But the physical symptoms, such as hot flashes, and emotional symptoms of menopause may disrupt your sleep, lower your energy or affect emotional health. There are many effective treatments available, from lifestyle adjustments to hormone therapy.

This study will be done on 60 subjects for 30 days to evaluate the efficacy of Menoveda Akira Tablets.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-01-03
• Study Start: 2023-02-02
• Last Update Posted: 2023-03-04

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1.Females from 45 to 70 years of age, post Menopause.
• 2.Females suffering from one or multiple mental health issues from- anxiety, insomnia, depression etc; 3.Females that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
• 4.Females willing to avoid participation in any other interventional clinical trial for the duration of the study.

Exclusion Criteria

• 1.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
• 2.Females that have participated in any other interventional clinical trial in the previous 30 days.
• 3.Females with known sensitivity to any of the constituents of the investigational product.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in SGA(Subject Global Assessment)	Baseline Day0 - Day 30

Secondary Outcome Measures

Name	Time	Method
Change in MENQOL(Menopause-Specific Quality of Life questionnaire) Score	Baseline Day0-Day30
Change in QOL (DASS-21)	Baseline Day0-Day30

Trial Locations

Locations (1)

Shree Ram Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Shree Ram Hospital

🇮🇳Meerut, UTTAR PRADESH, India

Dr Shikha Sharma

Principal investigator

7906672912

Shikhasharmamgcts@gmail.com