MenopauseKUDZU-01NCT04552106
Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
A study testing 3 caps x3/day, 3 caps x2/day and 2 caps x3/day in people with Menopause, run by Nordic Bioscience A/S at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- 3 caps x3/day, 3 caps x2/day and 2 caps x3/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Aug 2018to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Investigator considering the subject inappropriate for inclusion in the study based on medical interview and/or physical examination
- 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 locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Menopause
- Being tested
- 3 caps x3/day, 3 caps x2/day, 2 caps x3/day, 2 caps x2/day, 3 caps x1/day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 caps x3/dayDietary supplement
3 capsules 3 times daily for 28 days
3 caps x2/dayDietary supplement
3 capsules 2 times daily for 28 days
2 caps x3/dayDietary supplement
2 capsules 3 times daily for 28 days
2 caps x2/dayDietary supplement
2 capsules 2 times daily for 28 days
3 caps x1/dayDietary supplement
3 capsules 1 times daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 10 subjects Receives: Dietary Supplement: 3 caps x3/day |
| Group 2 | Active comparator | 10 subjects Receives: Dietary Supplement: 3 caps x2/day |
| Group 3 | Active comparator | 10 subjects Receives: Dietary Supplement: 2 caps x3/day |
| Group 4 | Active comparator | 10 subjects Receives: Dietary Supplement: 2 caps x2/day |
| Group 5 | Active comparator | 10 subjects Receives: Dietary Supplement: 3 caps x1/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Scale (MRS)
Questionaire. 11 likert scales 0-4. Total score ranges: 0-44 (0 indicating no symptoms, 44 indicating max symptoms.
Measured: 28 days
Serum CTX-I
Blood based biomarker of bone resorption
Measured: 28 days
Urine CTX-I
Urine based biomarker of bone resorption
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start7 Aug 2018
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded, single-center, randomized, exploratory, dose-finding study. 1:1:1:1:1 randomisation to 5 groups of different doses for 28 days.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Bioscience A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henning B Nielsen, DMSci, Principal investigator, Sanos Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552106
- Sponsor's protocol ID
- Protocol_V1.2_KUDZU
- Acronym
- KUDZU-01
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04552106
- Acronym / sponsor ID
- KUDZU-01 / Protocol_V1.2_KUDZU
- Conditions
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nordic Bioscience A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Unblinded, single-center, randomized, exploratory, dose-finding study. 1:1:1:1:1 randomisation to 5 groups of different doses for 28 days.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Dietary Supplement: 3 caps x3/day10 subjects |
| Group 2 | Active comparator | Dietary Supplement: 3 caps x2/day10 subjects |
| Group 3 | Active comparator | Dietary Supplement: 2 caps x3/day10 subjects |
| Group 4 | Active comparator | Dietary Supplement: 2 caps x2/day10 subjects |
| Group 5 | Active comparator | Dietary Supplement: 3 caps x1/day10 subjects |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 caps x3/day3 capsules 3 times daily for 28 days | Dietary supplement | Group 1 |
| 3 caps x2/day3 capsules 2 times daily for 28 days | Dietary supplement | Group 2 |
| 2 caps x3/day2 capsules 3 times daily for 28 days | Dietary supplement | Group 3 |
| 2 caps x2/day2 capsules 2 times daily for 28 days | Dietary supplement | Group 4 |
| 3 caps x1/day3 capsules 1 times daily for 28 days | Dietary supplement | Group 5 |
Primary outcome
Menopause Rating Scale (MRS)
Time frame: 28 days
Questionaire. 11 likert scales 0-4. Total score ranges: 0-44 (0 indicating no symptoms, 44 indicating max symptoms.
Serum CTX-I
Time frame: 28 days
Blood based biomarker of bone resorption
Urine CTX-I
Time frame: 28 days
Urine based biomarker of bone resorption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning B Nielsen, DMSci principal investigator
Sanos Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 caps x3/day, 3 caps x2/day and 2 caps x3/day in people with Menopause, run by Nordic Bioscience A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (MRS) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.