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Study of Earthful Women 40 plus Supplement in Menopause Symptom Management and Quality of Life improvement in Menopause Women.

To Evaluate the Efficacy and Safety of Earthful Women 40 plus Supplement in Menopause Symptom Management and Quality of Life improvement in Perimenopause and Postmenopausal (Menopause) Women. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074367
Enrollment
50
Registered
2024-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N958- Other specified menopausal and perimenopausal disorders

Interventions

Intervention1: Earthful Women Multivitamin 40+: Product Name - Earthful Women Multivitamin 40+ Consumption pattern/Frequency -consume 2 Capsules immediately after breakfast, lunch or dinner for 90 da

Sponsors

Kenzen Ventures Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Perimenopausal women and postmenopausal women in the age group of 40 to 65 years. 2. Participants who are apparently healthy. 3. Women who have at least 5 points of MRS score. 4. Calcium deficiency Biomarkers

Exclusion criteria

Exclusion criteria: 1. Perimenopausal women and postmenopausal women in the age group of 40 to 65 years. 2. Participants who are apparently healthy. 3. Women who have at least 5 points of MRS score. 4. Calcium deficiency Biomarkers

Design outcomes

Primary

MeasureTime frame
1.Changes in global scores of Menopausal Rating Scale (MRS). .The MRS Scale Measures the following parameters: (11 points - hot flashes, mood swings , anxiety, fatigue ,Body pains,sleep disturbances, vaginal dryness) 2. Calcium Biomarkers Timepoint: 1. (Day 0, Day30, Day 60 & Day 90) 2.Day 0 & Day 90—

Secondary

MeasureTime frame
1. Change in the frequency and severity of hot flushes 2. Change in the frequency and severity of night sweats. 3. Change in the frequency and severity of sleep disturbances. 4. Change in Fatigue assessment scale.( Hot Flushes, Heart discomfort, sleeping problems, depressive mood, irritability, Anxiety, physical and mental exhaustion, Sexual Problems, Bladder Problems, Dryness of Vagina, joint, Calcium Biomarkers and muscular discomfort) 5. Patient acceptance and satisfaction as analysed by Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) Questionnaire. 6. The Menopause Specific Quality of Life Questionnaire-MENQOLTimepoint: 1. Day 0, Day30, Day 60 & Day 90 2. Day 0, Day30, Day 60 & Day 90 3. Day 0, Day30, Day 60 & Day 90 4. Day 0, Day30, Day 60 & Day 90 5. Day 0, Day30, Day 60 & Day 90 6. Day 0, Day30, Day 60 & Day 90—

Countries

India

Contacts

Public ContactArvind Patnaik

Syncorp Health Pvt Ltd

arvind.p@syncorphealth.com9014308214

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026