Randomized Evaluation of Natural Extract for Menopausal Wellness (RENEW)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorIndia Glycols Ltd
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female subjects aged 45-60 years at screening.
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 > 9 at screening.
Average frequency of hot flashes >= 3 per day for at least 7 consecutive days prior to screening.
Disqualifiers
Body mass index (BMI) <= 18 kg/m2 or > 35 kg/m2.
History of endometrial hyperplasia, endometrial cancer, cervical cancer, breast cancer, or other sex hormone-related cancers.
History of uterine resection or hysterectomy.
Unexplained abnormal uterine bleeding occurring after >= 1 year of menopause.
Trial design
Design model
Parallel
Treatments tested in this trial
Shatavari (Asparagus racemosus) Extract
Dietary supplementShatavari (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 interventionMatching 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Shatavari Herbal ExtractExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Menopause Rating Scale (MRS) Total Score
Change in menopausal symptom severity from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Menopause Rating Scale (MRS). The MRS consists of 11 items covering somatic, psychological, and urogenital menopausal symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe symptoms), with a total score ranging from 0 to 44. Higher scores indicate greater severity of menopausal symptoms. A decrease in MRS total score indicates improvement in menopausal symptom burden.
Time frame
Baseline (Day 0) to End of Study (Day 56 ± 5 days)2
Change in Average Daily Hot Flash Frequency
Change in average daily hot flash frequency from the baseline run-in period to the end of treatment. Hot flash frequency will be calculated as the mean number of hot flashes recorded per day during the 7-day baseline run-in period before Day 0 and during the assessment period at the end of treatment. A decrease in average daily hot flash frequency indicates improvement.
Time frame
Baseline Run-in Period (7 days before Day 0) to End-of-Study Assessment (Day 56 ± 5 days)Secondary outcomes
1
Change in Beck Depression Inventory-II (BDI-II) Score
Change in depressive symptoms from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item self-report instrument assessing depressive symptoms. Each item is scored from 0 to 3, with a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. A decrease in BDI-II score indicates improvement in depressive symptoms.
Time frame
Baseline (Day 0) to End of Study (Day 56 ± 5 days)2
Change in Athens Insomnia Scale (AIS) Score
Change in sleep disturbance symptoms from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), as assessed using the Athens Insomnia Scale (AIS). The AIS is an 8-item self-report scale assessing sleep difficulty and related daytime functioning. Each item is scored from 0 to 3, with a total score ranging from 0 to 24. Higher scores indicate greater severity of insomnia symptoms. A decrease in AIS score indicates improvement in sleep symptoms.
Time frame
Baseline (Day 0) to End of Study (Day 56 ± 5 days)3
Change in Self-Reported Skin Radiance Score
Change in participant-reported skin radiance from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), assessed using the study-specific Participant-Reported Skin Health Questionnaire. Skin radiance is assessed using the predefined response scale in the questionnaire. Higher scores indicate better self-reported skin radiance.
Time frame
Baseline (Day 0) to End of Study (Day 56 ± 5 days)4
Change in Hair & Scalp CARE Questionnaire Total Score
Change in participant-reported hair and scalp health from baseline (Day 0) to the end of treatment (Day 56 ± 5 days), assessed using the Hair \& Scalp CARE questionnaire. The questionnaire contains 23 items assessing the psychological and functional impact of hair and scalp problems. Each item is scored using a 5-point response scale from 0 (Never) to 4 (All the time), with a total score ranging from 0 to 92. Higher scores indicate a greater impact of hair and scalp problems. A decrease in score indicates improvement.
Time frame
Baseline (Day 0) to End of Study (Day 56 ± 5 days)Sponsors and contacts
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Source ClinicalTrials.gov