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Clinical Trials/CTRI/2025/11/096876
CTRI/2025/11/096876
Recruiting
Not Applicable

A Multicenter, Randomized, Double Blind, Placebo Controlled, Comparative, Clinical Study to evaluate the Efficacy and Safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women.

MotherSoul Private Limited3 sites in 1 country66 target enrollmentStarted: November 10, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
MotherSoul Private Limited
Enrollment
66
Locations
3
Primary Endpoint
Proportion in Menopause Rating Scale (MRS) assessment from baseline to end of study.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

A Multicenter Randomized Double Blind Placebo Controlled Comparative Clinical Study to evaluate the Efficacy and Safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women.

Primary Objective:

To evaluate the efficacy of Shatavari Capsules for the treatment of Menopausal Symptoms in women.

Secondary Objective:

To evaluate the safety of Shatavari Capsules for the treatment of Menopausal Symptoms in women.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
40.00 Year(s) to 70.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Adult menopausal female participants, 40 to 70 years of age (both inclusive).
  • •Perimenopausal and postmenopausal participants who are experiencing bothersome Vasomotor Symptoms.
  • •Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months; post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months.
  • •Participants with menopause symptoms, defined as a score of greater than or equal to 9 to less than or equal to 16 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women).
  • •Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.

Exclusion Criteria

  • •Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation.
  • •Participants with present active medical, surgical, and gynaecological problems.
  • •History of malignancy or any ongoing malignancy.
  • •Participants with known history of uncontrolled hypertension and uncontrolled Type 2 Diabetes Mellitus.
  • •Participants with significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts); or cerebrovascular accident.
  • •Participants with clinically relevant current or past history of severe, unstable, or uncontrolled pulmonary, hepatic, endocrine, neurological, rheumatological and renal diseases necessitating medical care.
  • •Participants who are on hormone replacement therapy (HRT) for more than 3 months.
  • •Participants taking medications such as glucocorticoids, anticonvulsants, antipsychotics, anxiolytics, antidepressants, opioid pain relievers, hypnotics, methotrexate, etc.
  • •or any other drugs that may have an influence on the outcome of the study.
  • •Participants with sleep disturbances and who are on prescription/over the counter/herbal/nutraceutical or any other system of therapy for sleep related concerns.

Outcomes

Primary Outcomes

Proportion in Menopause Rating Scale (MRS) assessment from baseline to end of study.

Time Frame: 60 Days

Secondary Outcomes

  • Mean change in Menopause Rating Scale (MRS) assessment from baseline to end of study.(60 Days)
  • Mean change in Utian Quality of life Scale (UQOL) assessment from baseline to end of study.(60 Days)
  • Mean change in Depression Anxiety Stress Scale (DASS-21) assessment from baseline(to end of study.)
  • Mean change in Greene Climacteric Scale assessment from baseline to end of study.(60 Days)
  • Safety Endpoint:(The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters.)

Investigators

Sponsor
MotherSoul Private Limited
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Alaka C Godbole

Akshaya Surgical and Maternity Home

Study Sites (3)

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