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Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms

NCT04552106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Nordic Bioscience A/S

    lead INDUSTRY

Principal Investigators

  • Henning B Nielsen, DMSci · Sanos Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2018-11-15
Completion
2018-11-15

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552106 on ClinicalTrials.gov