Trials / Completed
CompletedNCT04552106
Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
An Open-label, Single-center, Randomized, Exploratory, Dose-finding Study to Evaluate Short Term Treatment With Different Doses of Oral Powdered Kudzu Root Extract in Women With at Least Mild Menopause Symptoms
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Nordic Bioscience A/S · Industry
- Sex
- Female
- Age
- 45 Years – 60 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 3 caps x3/day | 3 capsules 3 times daily for 28 days |
| DIETARY_SUPPLEMENT | 3 caps x2/day | 3 capsules 2 times daily for 28 days |
| DIETARY_SUPPLEMENT | 2 caps x3/day | 2 capsules 3 times daily for 28 days |
| DIETARY_SUPPLEMENT | 2 caps x2/day | 2 capsules 2 times daily for 28 days |
| DIETARY_SUPPLEMENT | 3 caps x1/day | 3 capsules 1 times daily for 28 days |
Timeline
- Start date
- 2018-08-07
- Primary completion
- 2018-11-15
- Completion
- 2018-11-15
- First posted
- 2020-09-17
- Last updated
- 2020-09-18
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04552106. Inclusion in this directory is not an endorsement.