Comparative study of KSM66 Ashwagandha (Withania somnifera) in women with Menopausal symptoms

Not Applicable

Completed

Conditions: Health Condition 1: N951- Menopausal and female climactericstates

Registration Number: CTRI/2022/09/045468

Lead Sponsor: Ixoreal Biomed Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

–Menopausal women aged 45 to 65 years with intact uterus and ovaries

–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

–Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.

–Body mass index 18-35 kg/m2

–Subject who has given written informed consent to participate in the study and understand the nature of the study

–Able to read and write in English or any other vernacular language

Exclusion Criteria

– Taking any form of herbal extract in the last 3 months before study entry

–On hormone replacement therapy (HRT) for more than 3 months

–Present active medical, surgical, and gynecological problems

–History of drug or alcohol abuse

–Undergone bilateral ovariectomy

–History of breast or cervical carcinoma

–Taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate

–Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematological, or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult

–Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study

–Evidence of uncooperative attitude, including poor compliance

–Inability to attend follow-up visit

–Subject with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the composite score of Menopause Rating Scale (MRS) from baseline to end of therapy. <br/ ><br>Scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms: <br/ ><br>a) Psychological domain: 0 to 16 scoring points <br/ ><br>b) Somato-vegetative domain: 0 to 16 points <br/ ><br>c) Urogenital domain: 0 to 12 pointsTimepoint: Baseline, 4 weeks and 12 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Change in Level of Estradiol from baseline to end of therapyTimepoint: Baseline, 4 weeks and 12 weeks;Change in Level of follicle stimulating hormone from baseline to end of therapyTimepoint: Baseline, 4 weeks and 12 weeks;Change in Level of luteinizing hormone from baseline to end of therapyTimepoint: Baseline, 4 weeks and 12 weeks <br/ ><br>;Change in Level of testosterone from baseline to end of therapyTimepoint: Baseline, 4 weeks and 12 weeks;Improvement in Perceived Stress Scale (PSS-10)Timepoint: Baseline, 4 weeks and 12 weeks;Improvement in the average hot flash score during 24 hours from baseline to end of the therapyTimepoint: Baseline, 4 weeks and 12 weeks;Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ)Timepoint: Baseline, 4 weeks and 12 weeks <br/ ><br>