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

A double blind, randomized, placebo controlled Clinical Study to Evaluate the efficacy of Menoveda Akira tablet in patients having menopause related mental health issues.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049316

Enrollment

Registered

2023-01-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F068- Other specified mental disorders due to known physiological condition

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Change in SGA(Subject Global Assessment)Timepoint: Baseline Day0 - Day 30	—

Secondary

Measure	Time frame
Change in MENQOL(Menopause-Specific Quality of Life questionnaire) ScoreTimepoint: Baseline Day0-Day30;Change in QOL (DASS-21)Timepoint: Baseline Day0-Day30	—

Countries

India

Contacts

Public ContactPuneet Mittal

Mittal Global Clinical Trial Services

puneetmittal@mgcts.org8937045757

Outcome results