CTRI/2024/09/074239RecruitingNot Applicable
Efficacy and Safety of Shatavari for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-blind, Two-arm, Parallel, Placebo-controlled Study
Ixoreal Biomed Private Limited1 site in 1 country80 target enrollmentStarted: October 4, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Mean change in score for Menopause Rating Scale (MRS) from baseline.
Study Overview
Brief Summary
· All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
· Subjects will be informed about the purpose of the study and signed informed consent will be taken.
· Blood sampling for efficacy and safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 3 (week 8).
· All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, and visit 3 (week 8) ± 4 days
· The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Menopausal women aged 40 to 55 years with intact uterus and ovaries.
- •2.Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days.
- •At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.
- •3.Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- •4.Body mass index 18-35 kg/m2 5.Subject who has given written informed consent to participate in the study and understand the nature of the study.
- •6.Able to read and write in English or any other vernacular language.
- •7.No plan to commence new treatments over the study period.
- •8.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
Exclusion Criteria
- •1.Participants taking any form of herbal extract in the last 3 months before study entry.
- •2.Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- •3.Participants with Present active medical, surgical, and gynaecological problems.
- •4.Participants with a history of alcohol, tobacco dependence, or any substance abuse.
- •5.Participants who had undergone bilateral ovariectomy 6.Participants with history of breast or cervical carcinoma 7.Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
- •8.Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.
- •9.Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •10.Participants with evidence of uncooperative attitude, including poor compliance.
- •11.Participants with inability to attend follow-up visit 12.Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
- •13.Patients who had participated in other clinical trials during the previous 3 months.
Outcomes
Primary Outcomes
Mean change in score for Menopause Rating Scale (MRS) from baseline.
Time Frame: Baseline, Week 4, Week 8
Secondary Outcomes
- Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline.(Baseline, Week 4, Week 8)
- Mean change in Menopause Symptoms Treatment Questionnaire (MENQOL) scores from baseline.(Baseline, Week 4, Week 8)
- Mean change in Profile of Mood States (POMS, abbreviated version) questionnaire scores from baseline.(Baseline, Week 4, Week 8)
- Mean change in Hot Flashes event from baseline.(Baseline, Week 4, Week 8)
- Mean change in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.(Baseline, Week 8)
- Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.(Baseline, Week 8)
- Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline.(Baseline, Week 8)
- Mean change in Thyroid (T3, T4, TSH) parameters from baseline.(Baseline, Week 8)
- Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.(Baseline, Week 4, Week 8)
- Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.(Baseline, Week 4, Week 8)
Investigators
Dr Suprlya Mahajan
Sr. Consultant
Study Sites (1)
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