Recruiting

Ashoka Bark & Shatavari

Sponsor:

Vidya USA Corporation

Code:

NCT07861295

Conditions

Menopause

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

Ashoka Bark and Shatavari

Placebo

Study Details

Brief summary:

This 12-week randomized, placebo-controlled clinical trial will evaluate the efficacy and safety of a daily oral supplement containing Ashoka Bark and Shatavari in women experiencing menopausal symptoms. Up to 50 participants will be randomized to receive either the active supplement or placebo, with 40 participants expected to complete the study. Participants will attend visits at Weeks 0, 6, and 12, where hormone levels (FSH and estradiol), menopausal symptoms, quality of life, anxiety, cognitive function, and sleep will be assessed using validated measures. The study will also explore changes in the vaginal microbiome and monitor safety and adherence throughout the trial. The study will be conducted at MusB Research in New Port Richey, Florida.

Conditions

Menopause

Study ID

NCT07861295

Start date

Oct 1, 2025

Status verified date

Sep, 2026

Completion date

Dec 15, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Females aged 40-65 years.
  • Postmenopausal women in good overall health and fulfilling menopausal criteria set at the MRS score more than 5.
  • Subjects had experienced absence of regular menstrual cycle for at least 3 months.
  • Willingness to sign consent, follow protocols and regimen intake, as well as maintain normal physical activity and follow study procedures.

Exclusion Criteria:

  • Not on Hormone Replacement Therapy (HRT) or had discontinued HRT at least 12 months before admission to the study.
  • History of breast cancer,
  • BMI ≥ 40mg/kg².
  • Prior removal of both ovaries.
  • Pregnancy, breastfeeding, or plans for pregnancy.
  • History of breast or uterine cancer, including hyperplasia, endometrial carcinoma, or cervical neoplasia.
  • Unstable medical conditions or clinically diagnosed depression requiring treatment.
  • Self-reported drug or alcohol abuse.
  • Allergy or sensitivity to herbal ingredients.
  • Undiagnosed abnormal vaginal bleeding;
  • A bilateral hysterectomy;
  • History of chronic alcoholism,
  • Medication hypersensitivity, or allergy to dietary supplement ingredients;
  • Acute systemic infection or abnormal laboratory values.
  • No antibiotics use in past 30 days.
  • No regular probiotics use in past 30 days.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ashoka Bark and Shatavari Intervention Arm

Participants assigned to this arm will receive the active investigational supplement containing Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus). Participants will take one capsule daily (100 mg) orally before or during a meal for 12 weeks. The intervention is intended to evaluate the effect of the botanical formulation on menopausal symptoms, hormonal measures, quality of life, and exploratory microbiome outcomes. Participants will complete scheduled study assessments, symptom tracking, safety monitoring, and adherence evaluations throughout the intervention period.

placebo comparator: Placebo Control Arm

Participants assigned to this arm will receive a matched placebo capsule administered orally once daily before or during a meal for 12 weeks. The placebo will be identical in appearance to the active supplement to maintain blinding. Participants will undergo the same clinical assessments, symptom evaluations, safety monitoring, and adherence assessments as the intervention arm to allow comparison of outcomes between groups.

Interventions

Ashoka Bark and Shatavari

The intervention is an oral botanical dietary supplement containing Ashoka Bark (Saraca asoca) and Shatavari (Asparagus racemosus) intended for the management of menopausal symptoms. Participants will consume one capsule daily (100 mg) before or during a meal for 12 weeks. The formulation is being evaluated for its potential effects on menopausal symptom severity, hormone-related measures, quality of life, and related health outcomes in postmenopausal women. The intervention will be compared with a matched placebo under randomized, double-blind study conditions. Safety, adherence, and tolerability will be monitored throughout the study period.

Placebo

Matched placebo capsule containing inactive ingredients, administered orally once daily before or during a meal for 12 weeks. The placebo is identical in appearance to the active Ashoka Bark and Shatavari supplement to maintain blinding of participants, investigators, and outcome assessors. The placebo contains no active botanical ingredients and is used as the comparator to evaluate the effects of the Ashoka Bark and Shatavari intervention on menopausal symptoms and related outcomes.

Primary outcome measure

  • Change in Menopausal Rating Scale total score [ Time Frame: Baseline (Day 0) to Week 12 (Day 84) ]
  • Change in Greene Climacteric Scale total score [ Time Frame: Baseline (Day 0) to Week 12 (Day ]
  • Change in Kupperman Menopausal Index total score [ Time Frame: Baseline (Day 0) to Week 12 (Day 84) ]
  • Change in serum follicle-stimulating hormone concentration [ Time Frame: Baseline (Day 0) to Week 12 (Day 84) ]
  • Change in serum estradiol concentration [ Time Frame: Baseline (Day 0) to Week 12 (Day 84) ]

Central Contacts and Locations

Locations

MusB Research LLC

Recruiting

New Port Richey, Florida, United States, 34653

Contacts

Prinicipal Investigator

8134190781info@musbdiagnostics.com

More Information

Sponsor

Vidya USA Corporation

Last update posted

Oct 6, 2026

Last verified

Sep, 2026

Keywords

  • Menopause
  • Postmenopausal Women
  • Menopausal Symptoms
  • Ashoka Bark
  • Saraca asoca
  • Shatavari
  • Asparagus racemosus
  • Botanical Supplement
  • Herbal Supplement
  • Non-Hormonal Therapy
  • Dietary Supplement
  • Vasomotor Symptoms
  • Hot Flashes
  • Follicle-Stimulating Hormone
  • Estradiol
  • Menopausal Rating Scale
  • Greene Climacteric Scale
  • Kupperman Menopausal Index
  • Vaginal Microbiome
  • Women's Health
  • Randomized Placebo-Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Vidya USA Corporation on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.