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

Nordic Bioscience

Status: Completed

Conditions: Menopause

Treatments: Dietary Supplement: 2 caps x3/day; Dietary Supplement: 2 caps x2/day; Dietary Supplement: 3 caps x2/day; Dietary Supplement: 3 caps x1/day; Dietary Supplement: 3 caps x3/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT04552106

Protocol_V1.2_KUDZU

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

Group 1

Active Comparator group

Description:

10 subjects

Treatment:

Dietary Supplement: 3 caps x3/day

Group 2

Active Comparator group

Description:

10 subjects

Treatment:

Dietary Supplement: 3 caps x2/day

Group 3

Active Comparator group

Description:

10 subjects

Treatment:

Dietary Supplement: 2 caps x3/day

Group 4

Active Comparator group

Description:

10 subjects

Treatment:

Dietary Supplement: 2 caps x2/day

Group 5

Active Comparator group

Description:

10 subjects

Treatment:

Dietary Supplement: 3 caps x1/day