100 Participants NeededMy employer runs this trial

Shatavari Extract for Menopause

(RENEW Trial)

Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: India Glycols Ltd

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for women aged 45 to 60 who have gone through menopause and are experiencing symptoms like hot flashes or trouble sleeping. Participants should be generally healthy and willing to take a daily supplement for 8 weeks.

Inclusion Criteria

Post-menopausal status defined as no menstrual period for at least 12 months, graded as post-menopausal per STRAW classification (not due to pregnancy, lactation, or medical/surgical causes)
Menopause Rating Scale (MRS) score greater than 9 at screening
Willing and able to provide written informed consent and comply with study procedures, including maintaining the daily hot-flash diary
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Exclusion Criteria

Body mass index (BMI) less than or equal to 18 kg/m2 or greater than 35 kg/m2
Uncontrolled diabetes defined as fasting blood glucose 180 mg/dL or higher or HbA1c greater than 9.5%
Excessive use of tobacco (more than 20 cigarettes/day), caffeine (more than 5 cups/day), or alcohol (more than 14 drinks/week) within 4 weeks prior to screening
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What Are the Treatments Tested in This Trial?

Interventions

  • Shatavari Extract

Trial Overview

The study compares an herbal extract containing Shatavari (Asparagus racemosus) plus natural bio-enhancers against a placebo. Women will be randomly assigned to one of the two groups, taking their assigned product daily for 8 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Shatavari Herbal ExtractExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

India Glycols Ltd

Lead Sponsor