Study to evaluate the safety and efficacy of KSM-66 Ashwagandha® capsule (300 mg) on Menopause Symptoms

Phase 3

Completed

• Registration Number: CTRI/2022/02/040551
• Lead Sponsor: Ixoreal Biomed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-30
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1.Adult female subjects of ageâ??s >= 45 years and <=55 years.

2.Female patients with clinical diagnosis of menopaue.

3.Patients who can and willing to provide written Informed Consent.

4.Female patients with BMI 20-30 Kg/m2.

5.Female patients who are having more than 10 Hot Flashes events per week.

6.Female patients willing to follow the procedures as per the study protocol.

7.Female patients who agree to take investigational product till Day 56.

8.Female patients who have not undergone any hormone therapy or antidepressant during the past 3 months before enrolment.

9.Patients having capability of complete compliance and completion of follow-up .

10.Participant / participantâ??s legally acceptable representative understands and can comply with clinical trial protocol requirements.

Exclusion Criteria

1.Female patients Ë? 45 years or Ë? 55 years of age.

2.Female patients who are severely anemic.

3.Female patients who had previous treatment with hormonal and bio-identical hormonal therapy

4.Female patients having a history of any bleeding disorders.

5.Female patients having a history or presence of any medical conditions which impacts the quality of life.

6.Female patients with hypersensitivity to study product or placebo.

7.Female patients currently using vitamin or mineral supplements, nutritional supplements and or medical foods estrogen, selective serotonin reuptake inhibitors within 30 days before the commencement of study or during the study.

8.Female patients using prescription medications and/or non-prescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.

9.Female patients who are currently pregnant and breast-feeding.

10.Female patients with current diagnosis or medical history of smoking, alcoholism and drug dependence.

11.Female patients having a history of breast, endometrial, other gynaecological cancer at any time or any other cancer within last 5 years.

12.Female patients who are not willing to take investigational product.

13.Patients with uncontrolled, unstable comorbidities.

14.Patients taking part in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.

15.Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled, unstable comorbidities.

16.Patients who had participated in other clinical trials during previous 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified