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

Menopause Clinical Trial

— KUDZU-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552106
• Other study ID #: Protocol_V1.2_KUDZU
• Status: Completed
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: September 2020
• Source: Nordic Bioscience A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 15, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause

Intervention

Dietary Supplement:
• 3 caps x3/day
3 capsules 3 times daily for 28 days
• 3 caps x2/day
3 capsules 2 times daily for 28 days
• 2 caps x3/day
2 capsules 3 times daily for 28 days
• 2 caps x2/day
2 capsules 2 times daily for 28 days
• 3 caps x1/day
3 capsules 1 times daily for 28 days

Locations

Country	Name	City	State
Denmark	Sanos Clinic	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Bioscience A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Serum CTX-I	Blood based biomarker of bone resorption	28 days
Primary	Urine CTX-I	Urine based biomarker of bone resorption	28 days