Actively Recruiting

Phase Not Applicable
Age: 45Years - 55Years
FEMALE
Healthy Volunteers
ID06716554

Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

Led by SF Research Institute, Inc. · Updated on 2024-12-04

51

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

Sponsors

S

SF Research Institute, Inc.

Lead Sponsor

I

Ixoreal Biomed Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Shatavari, a dietary supplement, for treating menopausal symptoms in women aged 45 to 65 years who have an intact uterus and ovaries. This randomized, double-blind, placebo-controlled study compares the safety and effectiveness of Shatavari alone, Shatavari combined with Ashwagandha, and a placebo. The main goal is to see how well Shatavari improves menopausal symptoms, with a secondary goal of assessing its safety. Participants will be randomly assigned to one of three groups: taking a capsule of Shatavari 300 mg, a capsule combining Shatavari 300 mg and Ashwagandha 250 mg, or a placebo capsule containing starch. Each capsule is taken once daily in the morning after breakfast with water for 8 weeks. Participants will maintain their usual diet and physical activities throughout the study. The study plans to enroll up to 51 women and complete with at least 45. Participants will attend three visits: a baseline visit at day 1, a mid-study visit at week 4, and an end-of-study visit at week 8. Assessments include physical exams, vital signs, blood tests measuring hormone levels (estradiol, FSH, LH, testosterone), and questionnaires on menopausal symptoms, stress, mood, and quality of life. Participants will record their medication use and any side effects in diaries. The primary outcome is the change in Menopause Rating Scale scores, with secondary outcomes measuring stress, mood, quality of life, and hormone levels.

CONDITIONS

Brief Title

Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

Who Can Participate

Age: 45Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Menopausal women aged 45 to 65 years with intact uterus and ovaries
  • Irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more than 7 days, or at least 2 cycles missing during the past 12 months, or menopause reported for at least 60 days
  • Complaints of menopausal symptoms such as hot flash, insomnia, migraine, or easy irritation
  • Body mass index between 18 and 35 kg/m2
  • Provided written informed consent and understands the study nature
  • Able to read and write in English or another vernacular language
  • No plans to start new treatments during the study period
  • Willing and able to comply with all study procedures
Not Eligible

You will not qualify if you...

  • Use of any herbal extract in the last 3 months before study entry
  • Hormone replacement therapy for more than 3 months
  • Present active medical, surgical, or gynecological problems
  • History of alcohol, tobacco dependence, or substance abuse
  • History of bilateral ovariectomy
  • History of breast or cervical cancer
  • Use of medications affecting bone metabolism including glucocorticoid, anticonvulsant, and methotrexate
  • Clinically relevant major systemic diseases making study difficult
  • Mental conditions preventing understanding of the study
  • Uncooperative attitude or poor compliance
  • Inability to attend follow-up visits
  • Other medical conditions interfering with study objectives
  • Known hypersensitivity to Ashwagandha
  • Participation in other clinical trials within the previous 3 months
  • Any clinical condition that prevents safe fulfillment of the trial protocol

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 8 weeks ± 4 days

Participants take one capsule of their assigned study medication daily at home for 8 weeks. They continue their routine diet and physical activities during this period.

3 visits (Baseline/Enrollment, Week 4, Week 8)

Trial Site Locations

Total: 1 location

1

SF Research Institute, Inc.

San Francisco, California, United States, 94127

Actively Recruiting

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Research Team

K

Khaleeq Rehman

J

John Ademola

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Efficacy and safety of Shatavari root extract (Asparagus racemosus) for menopausal symptoms: a randomized, double-blind, three-arm, placebo-controlled study.

John Ademola, Ashutosh Ajgaonkar, Tanisha Debnath...

https://pubmed.ncbi.nlm.nih.gov/41394012