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

Phase 3

Completed

• Conditions: Menopause

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

Brief Summary

Sixty female adults diagnosed with menopause, aged between 45 to 55 years of age (both inclusive) will be included in this study. There will be total 02 site visits and 01 telephonic interview during the study.

On screening/baseline visit, written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and her physical examinations will be done. Subject will be recruited in the study if she meets all the inclusion criteria. Subjects will undergo general and systemic examinations. At baseline visit and end of treatment visit, subjects will be provided with diary card to record daily symptoms. Symptoms will be assessed and graded on clinical symptom scoring scale. All subjects will be advised to continue their routine diet and physical activities.

During the study, Subject will be advised to consume 300 mg of Ashwagandha Formulation Twice daily orally after food with a glass of water or milk for 56 days. The investigator on each visit will also assess drug compliance.

Subjects will be called to the study centre on Baseline & 56 the day from the baseline visit. On every physical visit, subjects will undergo general and systemic examinations and assessment of clinical symptoms will be done.  There will be a telephonic follow-up visit on Day 28 to check IP and Protocol Compliance along with the AE detail collection.

Subjects will be contacted telephonically on Day 28 (Visit 2). They will be enquired about adverse events and concomitant medication. Dosing compliance will also be checked and recorded.

Subjects will be randomized to either one of the two treatment arms. Subjects will be instructed to take the one capsule of study medication to which they are randomized, twice a day after breakfast and dinner, with ambient temperature water for 56 consecutive days at home.

Adverse events and concomitant medication will be recorded throughout the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-28
• Study Completion: 2022-11-30
• Last Update Posted: 2023-09-03

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 1.Adult female subjects of age’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 / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.

Exclusion Criteria

• 1.Female patients Ë‚ 45 years or ˃ 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

Primary Outcome Measures

Name	Time	Method
Reduction in Menopause Rating Scale score from baseline to the end of study	Baseline, Day 56

Secondary Outcome Measures

Name	Time	Method
1.Change in Hormonal Parameters (Serum Oestradiol, Progesterone, LH & FSH)	2.Changes in Hot Flashes event between Baseline and Day 56

Trial Locations

Locations (1)

Govt. Medical College & Govt. General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Govt. Medical College & Govt. General Hospital (Old RIMSGGH)

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr Isukapalli Vani

Principal investigator

7569427836

drivaniggh@yahoo.com