A randomized, double-blind clinical study to evaluate the safety and efficacy of GSWHS1 in promoting wellness during the Menopausal transition or in subjects who have reached menopause.

A Randomized, Double-blind, Clinical trial to investigate the Efficacy and Safety of GSWHS1 in promoting wellness during the Menopausal Transition.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088943

Enrollment

Registered

2025-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: N951- Menopausal and female climactericstates

Interventions

Intervention1: GSWHS1 + Placebo: 1 Capsule of GSWHS1 per day and 1 Capsule of Placebo per day for 6 months. Intervention2: GSWHS1: 2 Capsules of GSWHS1 per day for 6 months. Control Intervention1: Pla

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women who have attained menopause or are more than 40 years old and had at least the last 3 cycles with irregular periods. 2. Women experiencing at least one moderate-to-severe menopausal symptom along with joint discomfort (e.g., hot flashes, night sweats, mood swings, stress-induced sleep disturbances). 3. Women who otherwise are healthy with no significant comorbid conditions that would interfere with study participation. 4. The subject is willing to provide written informed consent and comply with study procedures.

Exclusion criteria

Exclusion criteria: 1. Use of hormone replacement therapy (HRT) or other hormonal treatments in the past 3 months. 2. Women with significant cardiovascular, liver, or renal disease or any condition that could interfere with study participation. 3. Women with a history of hormone-dependent cancers (e.g., breast, ovarian, or endometrial cancer). 4. Women who have undergone major surgery or have uncontrolled medical conditions in the past 3 months. 5. Women having a BMI of more than 35. 6. Known hypersensitivity to any ingredients in the study product.

Design outcomes

Primary

Measure	Time frame
1.To assess the efficacy of GSWHS1 women health supplement on bone health and metabolic markers. Markers include bone mineral density (BMD), serum calcium levels, and glycaemic markers: fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated haemoglobin (HbA1c). 2. To evaluate the effect of GSWHS1 women health supplement on menopausal symptoms, including hot flashes, mood disturbances. Assessments will be done using the Menopause Rating Scale (MRS) and the Greene Climacteric Scale, which measure common symptoms of menopause such as vasomotor symptoms, sleep disturbances, irritability, and anxiety. 3. To determine the right dose of GSWHS1 for promoting wellness during the menopausal transition. Timepoint: Baseline/Day 1, Month 1, Month 3, Month 5 and Month 6.	—

Measure

Time frame

1.To assess the efficacy of GSWHS1 women health supplement on bone health and metabolic markers. Markers include bone mineral density (BMD), serum calcium levels, and glycaemic markers: fasting plasma glucose (FPG), postprandial plasma glucose (PPG), glycated haemoglobin (HbA1c). 2. To evaluate the effect of GSWHS1 women health supplement on menopausal symptoms, including hot flashes, mood disturbances. Assessments will be done using the Menopause Rating Scale (MRS) and the Greene Climacteric Scale, which measure common symptoms of menopause such as vasomotor symptoms, sleep disturbances, irritability, and anxiety. 3. To determine the right dose of GSWHS1 for promoting wellness during the menopausal transition. Timepoint: Baseline/Day 1, Month 1, Month 3, Month 5 and Month 6.

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Secondary

Measure	Time frame
To evaluate the effect of GSWHS1 on inflammation and joint health. Inflammation will be assessed through measuring the levels of Erythrocyte Sedimentation Rate (ESR). Joint pain and stiffness will be measured using the WOMAC Index (Western Ontario and McMaster Universities Osteoarthritis Index). Timepoint: Baseline/Day 1, Month 1, Month 3, Month 5 and Month 6.;To assess the effect of GSWHS1 on reducing stress levels there by improving mild sleep quality Stress levels will be measured using the Brief Mood Introspection Scale (BMIS) Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). Timepoint: Baseline/Day 1, Month 1, Month 3, Month 5 and Month 6.	—

Measure

Time frame

To evaluate the effect of GSWHS1 on inflammation and joint health. Inflammation will be assessed through measuring the levels of Erythrocyte Sedimentation Rate (ESR). Joint pain and stiffness will be measured using the WOMAC Index (Western Ontario and McMaster Universities Osteoarthritis Index). Timepoint: Baseline/Day 1, Month 1, Month 3, Month 5 and Month 6.;To assess the effect of GSWHS1 on reducing stress levels there by improving mild sleep quality Stress levels will be measured using the Brief Mood Introspection Scale (BMIS) Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). Timepoint: Baseline/Day 1, Month 1, Month 3, Month 5 and Month 6.

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Countries

India

Contacts

Public ContactMr Ayan Neogi

Vivforever

ayanneogi@vivforever.in9967968612

Outcome results

None listed

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