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Shatavari for Menopause
N/A
Recruiting
Research Sponsored by SF Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Menopausal women aged 45 to 65 years with intact uterus and ovaries
Be between 18 and 65 years old
Must not have
Participants who are on hormone replacement therapy (HRT) for more than 3 months
Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pss assessment will be done at visit 1, screening visit/ enrolment visit/ baseline visit, (day 1), visit 2 (week 4), visit 3 end of study visit, (week 8).
Summary
"This trial is studying the effects of Shatavari on menopausal symptoms in women. Participants will be divided into three groups and will take either Shatavari, Shatavari +
Who is the study for?
This trial is for women experiencing menopause with symptoms like hot flashes and depression. Participants should take a capsule daily after breakfast for 8 weeks, without changing their diet or exercise routines.
What is being tested?
The study tests the effectiveness of Shatavari alone or combined with Ashwagandha against a placebo in reducing menopausal symptoms. Women are randomly assigned to one of three groups in this double-blind study.
What are the potential side effects?
Potential side effects were not provided, but typically herbal supplements like Shatavari and Ashwagandha may cause digestive upset, allergic reactions, or interact with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 45-65, not undergoing menopause, with my uterus and ovaries intact.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been on hormone replacement therapy for over 3 months.
Select...
I am taking medication that affects bone health, like steroids or methotrexate.
Select...
I have had both of my ovaries surgically removed.
Select...
I cannot attend follow-up visits.
Select...
I currently have active health issues that need medical attention.
Select...
I have a history of breast or cervical cancer.
Select...
I understand the details and risks of the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pss assessment will be done at visit 1, screening visit/ enrolment visit/ baseline visit, (day 1), visit 2 (week 4), visit 3 end of study visit, (week 8).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pss assessment will be done at visit 1, screening visit/ enrolment visit/ baseline visit, (day 1), visit 2 (week 4), visit 3 end of study visit, (week 8).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Menopause Rating Scale (MRS)
Secondary study objectives
Menopause-Specific Quality of Life Questionnaire (MENQOL)
Perceived Stress Scale (PSS)
Profile of Mood States (POMS, abbreviated version)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Shatavari + AshwagandhaExperimental Treatment1 Intervention
One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water.
Group II: ShatavariExperimental Treatment1 Intervention
One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water.
Group III: PlaceboPlacebo Group1 Intervention
One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water.
Find a Location
Who is running the clinical trial?
Ixoreal Biomed Inc.UNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
SF Research Institute, Inc.Lead Sponsor
6 Previous Clinical Trials
491 Total Patients Enrolled