Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
NCT ID: NCT04552106
Last Updated: 2020-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-08-07
2018-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
10 subjects
3 caps x3/day
3 capsules 3 times daily for 28 days
Group 2
10 subjects
3 caps x2/day
3 capsules 2 times daily for 28 days
Group 3
10 subjects
2 caps x3/day
2 capsules 3 times daily for 28 days
Group 4
10 subjects
2 caps x2/day
2 capsules 2 times daily for 28 days
Group 5
10 subjects
3 caps x1/day
3 capsules 1 times daily for 28 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
60 Years
FEMALE
No
Sponsors
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Nordic Bioscience A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Henning B Nielsen, DMSci
Role: PRINCIPAL_INVESTIGATOR
Sanos Clinic
Locations
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Sanos Clinic
Herlev, , Denmark
Countries
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Other Identifiers
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Protocol_V1.2_KUDZU
Identifier Type: -
Identifier Source: org_study_id
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