Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)

Conditions

• Hot Flashes
• Menopause

Eligibility Criteria

Sex

FEMALE

Age

45 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Shatavari (Asparagus racemosus) Extract — DIETARY_SUPPLEMENT
  Shatavari (Asparagus racemosus) extract provided as a 400 mg oral capsule containing Shatavari extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The intervention will be administered under double-blind conditions and compared with a matching placebo.
• Placebo — OTHER
  Matching placebo capsule formulated to match the active Shatavari study product in appearance and administration. Participants will take one capsule orally once daily, preferably with water at approximately the same time each day, for 8 weeks. The placebo will contain no active Shatavari extract and will be used as the comparator under double-blind conditions.

Study Details

This study will evaluate whether an 8-week course of a standardized herbal extract containing Shatavari and natural bio-enhancer ingredients can reduce menopausal symptoms in post-menopausal women. The study will compare the herbal extract with a matching placebo. Approximately 100 women aged 45 to 60 years with menopausal symptoms will be enrolled, with approximately 80 expected to complete the study. Participants will take one study product daily for 8 weeks. Menopausal symptoms, including hot flashes, mood, sleep, skin health, and hair and scalp health, will be assessed using questionnaires, a daily hot flash diary, blood tests, and safety assessments.

Key Dates

First listed

Sep 22, 2026

Start date

Sep 1, 2026

Status verified

Sep 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Shatavari Herbal Extract
  Participants assigned to this arm will receive one 400 mg study capsule orally once daily for 8 weeks. The study product contains Shatavari (Asparagus racemosus) extract with natural bio-enhancer additives, including piperine, quercetin, naringin, and silicon dioxide, with a total capsule weight of 400 mg. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes.
• Placebo Comparator: Placebo
  Participants assigned to this arm will receive one matching placebo capsule orally once daily for 8 weeks. The placebo will be formulated to match the appearance and administration of the active study product. Participants will be instructed to take the study product at approximately the same time each day, preferably with water. Participants will maintain a daily hot flash diary and complete scheduled study assessments to evaluate menopausal symptoms, safety, adherence, and other study outcomes.

Primary Outcome Measure

Change in Menopause Rating Scale (MRS) Total Score [ Time Frame: Baseline (Day 0) to End of Study (Day 56 ± 5 days) ]

Locations (1)

Find similar trials in New Port Richey, FL

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