Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
Not Applicable
Completed
- Conditions
- Menopause
- Interventions
- Dietary Supplement: 3 caps x1/dayDietary Supplement: 2 caps x3/dayDietary Supplement: 2 caps x2/dayDietary Supplement: 3 caps x3/dayDietary Supplement: 3 caps x2/day
- Registration Number
- NCT04552106
- Lead Sponsor
- Nordic Bioscience A/S
- Brief Summary
The aim of the study is to investigate effects of daily intake of Nordic Kudzu for 28 days in 5 groups of 10 menopausal women with symptoms. Groups:1) 3 capsules x3/day, 2) 3 capsules x2/day, 3) 2 capsules x3/day, 4) 2 capsules x2/day, 5) 3 capsules x1/day. Each capsule equal 1.26 g kudzu root extract. Outcome measures: Serum and urine levels of biochemical marker of bone-degradation, CTX-I, and symptoms of menopause using the Meopause Rating Scale (MRS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 5 3 caps x1/day 10 subjects Group 3 2 caps x3/day 10 subjects Group 4 2 caps x2/day 10 subjects Group 1 3 caps x3/day 10 subjects Group 2 3 caps x2/day 10 subjects
- Primary Outcome Measures
Name Time Method Menopause Rating Scale (MRS) 28 days Questionaire. 11 likert scales 0-4. Total score ranges: 0-44 (0 indicating no symptoms, 44 indicating max symptoms.
Serum CTX-I 28 days Blood based biomarker of bone resorption
Urine CTX-I 28 days Urine based biomarker of bone resorption
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sanos Clinic
🇩🇰Herlev, Denmark