NCT04552106

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 10, 2020

Last Update Submit

September 16, 2020

Conditions

Menopause

Outcome Measures

Primary Outcomes (3)

  • Menopause Rating Scale (MRS)

    Questionaire. 11 likert scales 0-4. Total score ranges: 0-44 (0 indicating no symptoms, 44 indicating max symptoms.

    28 days

  • Serum CTX-I

    Blood based biomarker of bone resorption

    28 days

  • Urine CTX-I

    Urine based biomarker of bone resorption

    28 days

Study Arms (5)

Group 1

ACTIVE COMPARATOR

10 subjects

Dietary Supplement: 3 caps x3/day

Group 2

ACTIVE COMPARATOR

10 subjects

Dietary Supplement: 3 caps x2/day

Group 3

ACTIVE COMPARATOR

10 subjects

Dietary Supplement: 2 caps x3/day

Group 4

ACTIVE COMPARATOR

10 subjects

Dietary Supplement: 2 caps x2/day

Group 5

ACTIVE COMPARATOR

10 subjects

Dietary Supplement: 3 caps x1/day

Interventions

3 caps x3/dayDIETARY_SUPPLEMENT

3 capsules 3 times daily for 28 days

Group 1
3 caps x2/dayDIETARY_SUPPLEMENT

3 capsules 2 times daily for 28 days

Group 2
2 caps x3/dayDIETARY_SUPPLEMENT

2 capsules 3 times daily for 28 days

Group 3
2 caps x2/dayDIETARY_SUPPLEMENT

2 capsules 2 times daily for 28 days

Group 4
3 caps x1/dayDIETARY_SUPPLEMENT

3 capsules 1 times daily for 28 days

Group 5

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Signed and dated informed consent
  • Women in the age between 45 and 60 years considered late peri- (defined as having had a menstrual period more than 3 months ago but less than 12 months ago) or postmenopausal (defined as at least 12 consecutive months without any menstrual flow) at the time of screening
  • Menopause symptoms, defined as a score of at least 5 in the Menopausal Rating Scale (MRS) at screening
  • Body Mass Index between 18 and 40 kg/m2 at the time of screening

You may not qualify if:

  • Allergy/hypersensitivity/intolerance to any components in the Kudzu herbal extract powder capsules
  • Past or present significant co-morbidity including, but not limited to: Uncontrolled, severe renal, hepatic, cardiovascular, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease
  • History of breast cancer or other malignancy, except adequately treated basal cell or squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
  • Known history of clinically significant thromboembolism
  • Current alcohol abuse
  • Pregnancy, determined by positive serum human chorionic gonadotropin (hCG) test prior to randomization, except for women considered postmenopausal
  • Breastfeeding women
  • Participation in a study trial with any investigational new drug or food supplement within 3 months prior to the start of the study
  • Clinically significant ECG abnormalities, as judged by the investigator
  • Clinically significant biochemistry abnormalities including but not limited to ALT or AST \>2.5 x ULN or other clinically significant liver function parameters, as judged by the investigator
  • Use of local or systemic conventional hormone therapy regardless of indication or alternative medication including dietary supplements for the treatment of menopausal symptoms within 28 days prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanos Clinic

Herlev, 2730, Denmark

Location

Study Officials

  • Henning B Nielsen, DMSci

    Sanos Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Unblinded, single-center, randomized, exploratory, dose-finding study. 1:1:1:1:1 randomisation to 5 groups of different doses for 28 days.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2020

First Posted

September 17, 2020

Study Start

August 7, 2018

Primary Completion

November 15, 2018

Study Completion

November 15, 2018

Last Updated

September 18, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)