To study efficacy and safety of capsule menoease compared with placebo in women with menopausal symptoms

Phase 2

• Conditions: Health Condition 1: null- women with menopausal symptoms

• Registration Number: CTRI/2015/02/005585
• Lead Sponsor: Charak Pharma Pvt Ltd CPP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria

The participant may enter the trial if ALL of the following apply:

Participant is willing and able to give informed consent for participation in the trial

Female of age : 45 Years to 55 Years with menopausal symptoms

Absence of menstrual period for 6 to 12 months but not more than 2 years

Participant has clinically acceptable laboratory results

In the investigatorâ??s opinion, is able and willing to comply with all trial requirements

Exclusion Criteria

Exclusion Criteria

The participant may not enter the trial if ANY of the following apply:

Women on HRT or post HRT

Treatment with estrogens, progesterone, Raloxifene, or Tamoxifen

Use of prescription or over-the-counter medications to treat hot flushes

Known history of Hyperthyroidism or Hypothyroidism

Clinically suspected benign or malignant lesions in uterus, cervix or vagina

Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial

Participants who have participated in another research trial involving an investigational product in the past 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified