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

Completed

• Conditions: Menopausal and female climactericstates,

• Registration Number: CTRI/2022/09/045468
• Lead Sponsor: Ixoreal Biomed Private Limited

Brief Summary

This prospective, randomized, double-blind, placebo-controlled study shall compare the efficacy and safety of extract of KSM66 Ashwagandha (Withania somnifera) with placebo in improving menopausal symptoms in women.

1.      Menopausal women aged 45 to 65 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. Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.

3.      Those not willing to participate and not literate shall be exclude. Women will be randomized to receive either ashwagandha extract capsule 300 mg two times daily or placebo capsule (identical to ashwagandha capsule) two times daily for 12 weeks.

4.      Assessments shall be done using the Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) (8-item self-administered questionnaire at the end of every 4 weeks of therapy), Improvement in Perceived Stress Scale (PSS-10) from baseline to end of therapy, Improvement in the average hot flash score during 24 hours from baseline to end of the therapy, Change in Level of Estradiol from baseline to end of therapy, Change in Level of follicle stimulating hormone from baseline to end of therapy, Change in Level of luteinizing hormone from baseline to end of therapy, Change in Level of testosterone from baseline to end of therapy and clinical adverse events over a period of 12 weeks (follow-up visits 4 and 12 weeks)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Study Completion: 2024-03-14
• Last Update Posted: 2024-08-08

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

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.
• –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.	Baseline, 4 weeks and 12 weeks
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:	Baseline, 4 weeks and 12 weeks
a) Psychological domain: 0 to 16 scoring points	Baseline, 4 weeks and 12 weeks
b) Somato-vegetative domain: 0 to 16 points	Baseline, 4 weeks and 12 weeks
c) Urogenital domain: 0 to 12 points	Baseline, 4 weeks and 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shri B. M. Patil Medical hospital & Research center; 🇮🇳 Bijapur, KARNATAKA, India

Shri B. M. Patil Medical hospital & Research center

🇮🇳Bijapur, KARNATAKA, India

Dr Neelamma Patil

Principal investigator

09845068074

neelamma.patil@bldedu.ac.in