Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:42 AM
Study NCT ID:
NCT04552106
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2020-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
Sponsor:
Nordic Bioscience A/S
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KUDZU-01
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: