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

Part of paid clinical trials in San Francisco, California.

Sponsor
SF Research Institute, Inc.
Study ID
NCT06716554
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
45 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Shatavari extract — DIETARY_SUPPLEMENT
    Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.
  • Shatavari + Ashwagandha extract — DIETARY_SUPPLEMENT
    Shatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily.
  • Placebo — DIETARY_SUPPLEMENT
    Placebo (starch)

Study Details

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.

Key Dates

Start date
Oct 26, 2024
Status verified
Nov 2024
Primary completion
Dec 26, 2024
Completion
Jan 20, 2025

Study Design

Enrollment
51 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Shatavari
    One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water.
  • Experimental: Shatavari + Ashwagandha
    One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water.
  • Placebo Comparator: Placebo
    One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water.

Primary Outcome Measure

Menopause Rating Scale (MRS) [ Time Frame: MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SF Research Institute, Inc.San FranciscoCalifornia94127
John Ademola
[email protected]
415-845-4638

Find similar trials in San Francisco, CA

By condition
Menopause
By specialty
Women's healthFertility
By research site
SF Research Institute, Inc.· San Francisco, CA

Related Studies