Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms (KUDZU-01)

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

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).

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Dietary supplement: 3 caps x3/day; Dietary supplement: 3 caps x2/day; Dietary supplement: 2 caps x3/day; Dietary supplement: 2 caps x2/day; Dietary supplement: 3 caps x1/day

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Sanos Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

1. Signed and dated informed consent
2. 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
3. Menopause symptoms, defined as a score of at least 5 in the Menopausal Rating Scale (MRS) at screening
4. Body Mass Index between 18 and 40 kg/m2 at the time of screening

Exclusion criteria:

1. Allergy/hypersensitivity/intolerance to any components in the Kudzu herbal extract powder capsules
2. 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
3. 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
4. Known history of clinically significant thromboembolism
5. Current alcohol abuse
6. Pregnancy, determined by positive serum human chorionic gonadotropin (hCG) test prior to randomization, except for women considered postmenopausal
7. Breastfeeding women
8. Participation in a study trial with any investigational new drug or food supplement within 3 months prior to the start of the study
9. Clinically significant ECG abnormalities, as judged by the investigator
10. 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
11. Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 10 subjects	Dietary supplement: 3 caps x3/day; 3 capsules 3 times daily for 28 days
Active Comparator: Group 2; 10 subjects	Dietary supplement: 3 caps x2/day; 3 capsules 2 times daily for 28 days
Active Comparator: Group 3; 10 subjects	Dietary supplement: 2 caps x3/day; 2 capsules 3 times daily for 28 days
Active Comparator: Group 4; 10 subjects	Dietary supplement: 2 caps x2/day; 2 capsules 2 times daily for 28 days
Active Comparator: Group 5; 10 subjects	Dietary supplement: 3 caps x1/day; 3 capsules 1 times daily for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nordic Bioscience A/S
• Investigators: Principal Investigator: Henning B Nielsen, DMSci, Sanos Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Actual): November 15, 2018
• Study Completion (Actual): November 15, 2018

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Protocol_V1.2_KUDZU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No