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A clinical Trial to Check the Safety and Efficacy of Women Health Formulation on Menopausal Comfort, Hormonal Balance, Mood and Metabolic Parameters in Females aged 35 55 years.

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Women Health Formulation on Menopausal Comfort, Hormonal Balance, Mood and Metabolic Parameters in Females aged 35 55 years. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110888
Enrollment
30
Registered
2026-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: E639- Nutritional deficiency, unspecified

Interventions

Intervention1: Nutraceutical women health formulation supplement (100 mg): 01 Capsule to be taken daily for 12weeks. Control Intervention1: Placebo (100 mg): 01 Capsule to be taken daily for 12weeks.

Sponsors

PADMALIFE NUTRITION PRIVATE LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Females aged 35-55years. 2. Irregular menstrual cycles (last 6-12 months). 3. Body mass index (BMI) 18.0 and 30.0 kg per m . 4. Mild-moderate menopausal symptoms

Exclusion criteria

Exclusion criteria: Pregnancy or lactation. Recent hormonal therapy changes (less than 3 months). Psychiatric or endocrine disorders. Allergies to study ingredients. Current use of interfering supplements or medications. Participation in another clinical trial within the past 30 days prior to screening or planned participation in another interventional study during the study period. Alcohol consumption and smoking. Receive hormonal replacement therapy or herbal supplements for menopausal symptoms.

Design outcomes

Primary

MeasureTime frame
Change in Menopausal symptoms severity (MRS)Timepoint: Screening visit and End of study Visit.—

Secondary

MeasureTime frame
1.Estradiol & FSH levels. 2. Luteinizing Hormone (LH) & Progesterone. 3. Menopause-Specific Quality of Life Questionnaire (MENQOL). 4. DASS-21 total & subscale scores. 5. Profile of Mood States (POMS). 6. Regensburg Insomnia Scale (RIS). 7. Treatment satisfaction (MS-TSQ). 8. Patient Global Impression of Change (PGIC)Timepoint: Screening visit & End of study Visit.—

Countries

India

Contacts

Public ContactShalini Dayananda

Unitree Health Care & Diagnostics

unitreeclinicalresearch@gmail.com919880996866

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026