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NCT04552106: KUDZU-01
Dose Finding Evaluation of Kudzu Root Extract in Women With Menopause Symptoms
NA trial testing 3 caps x3/day in Menopause in 50 participants. Completed in 15 November 2018.
15 November 2018
Quick facts
| Lead sponsor | Nordic Bioscience A/S |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 7 August 2018 |
| Primary completion | 15 November 2018 |
| Estimated completion | 15 November 2018 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- 3 caps x3/day
- 3 caps x2/day
- 2 caps x3/day
- 2 caps x2/day
- 3 caps x1/day
Conditions studied
- Menopause — all drugs for Menopause →
Sponsor
Nordic Bioscience A/S — full company profile →
Who can join
Adults 45 to 60, female only, with Menopause. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The Efficacy and Safety of Multiple Dose Regimens of Kudzu (<i>Pueraria lobata</i>) Root Extract on Bone and Cartilage Turnover and Menopausal Symptoms.
Bihlet AR, Byrjalsen I, Andersen JR, Simonsen SF, et al · · 2021 · cited 7× · PMID 34744740 · DOI 10.3389/fphar.2021.760629
Verify or expand the search:
- PubMed search for NCT04552106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Nordic Bioscience A/S trials
Trials by the same sponsor.
- NCT04542668 — The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis · NA · completed
- NCT04542655 — The Effect of Exercise on Serum Levels of Collagen and Proteoglycan in Patients With Knee Osteoarthritis (EFEX-OA-01) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04552106 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nordic Bioscience A/S
- Last refreshed: 18 September 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04552106.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing