Evaluation of efficacy and safety of ASPURUS for management of menopausal symptoms

Phase 4

Conditions: Health Condition 1: N95- Menopausal and other perimenopausal disorders

Registration Number: CTRI/2023/08/056569

Lead Sponsor: Waleria Healthtech Pvt. Ltd.,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Female subjects aged 40 years to 65 years .

2.Subjects who are experiencing menopausal symptoms such as hot flushes, night sweats, anxiety, depression, insomnia etc., as diagnosed by the study investigator.

3.Subjects who are otherwise healthy except for the menopausal symptoms.

4.Subjects or their legally acceptable representative are willing to provide informed written consent and agree to adhere to the study procedures.

Exclusion Criteria

1.Pregnant, planning to become pregnant or breastfeeding women.

2.Subjects who have undergone partial or complete hysterectomy

3.Subjects who are undertaking hormone replacement therapy or any other herbal medicine treatment for menopausal symptoms.

4.Current or history of a serious illnesses in the last three months which as per the study investigator will impact the study outcomes.

5.History of or current Alcohol or substance abuse

6.Allergy or sensitivity to any of the ingredients in the study treatment

7.Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.

8.Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total score of Utian Quality of Life (UQOL) at day 30 & 60 as compared to baselineTimepoint: baseline, day 30 & day 60

Secondary Outcome Measures

Name	Time	Method
Change in 21 item Depression, Anxiety & Stress Scale (DASS-21) Score at day 30 and 60 as compared to baselineTimepoint: baseline, day 30 & day 60;Change in individual domain scores of UQOL at day 30 & 60 as compared to baselineTimepoint: baseline, day 30 & day 60;Change in mean serum levels of estradiol & progesterone at day 60 as compared to baselineTimepoint: baseline, day 30 & day 60;Change in Menopause Symptom status, telephonically assessed using 5-pont Likert Scale at Day 7 & Day 14 & visit assessment at day 30 & day 60 as compared to baselineTimepoint: baseline, day 7, day14, day 30 & day 60;Change in Regensburg Insomnia Scale score at day 30 & day 60 as compared to baselineTimepoint: baseline, day 30 & day 60;Satisfaction with treatment captured using Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) at day 30 & day 60Timepoint: day 30 & day 60