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

A Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of Capsule Menoease in Women with Menopausal Symptoms - MNES

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/02/005585

Enrollment

Registered

2015-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- women with menopausal symptoms

Interventions

Intervention1: capsule Menoease: one capsule twice a day for 12 weeks Control Intervention1: Placebo: one capsule twice a day for 12 weeks

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of capsule Menoease in women presenting with signs and symptoms of menopauseTimepoint: Number of patients showing improvement in vasomotor symptoms, symptoms related to sexual activity, urinary symptoms through change in values at baseline and thereafter at the completion of study	—

Secondary

Measure	Time frame
1. To assess efficacy of Capsule Menoease compared with placebo capsules in women with menopausal symptoms 2. To assess investigatorâ??s and patients compliance Timepoint: Number of patients showing improvement in vasomotor symptoms, symptoms related to sexual activity, urinary symptoms through change in values at baseline and thereafter at the completion of study 1.Investigatorâ??s global assessment 2.Patientsâ?? global assessment 3.Patientsâ?? reporting and investigatorâ??s assessment of adverse reactions	—

Measure

Time frame

1. To assess efficacy of Capsule Menoease compared with placebo capsules in women with menopausal symptoms 2. To assess investigatorâ??s and patients compliance Timepoint: Number of patients showing improvement in vasomotor symptoms, symptoms related to sexual activity, urinary symptoms through change in values at baseline and thereafter at the completion of study 1.Investigatorâ??s global assessment 2.Patientsâ?? global assessment 3.Patientsâ?? reporting and investigatorâ??s assessment of adverse reactions

—

Countries

India

Contacts

Public ContactDr Divya Ramugade

Y.M.T Ayurvedic Medical College, Kharghar, Navi Mumbai

vedam06@yahoo.co.in9324446071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026