Can an ancient herbal formula tame gout?
NCT ID NCT05499312
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This trial tests whether an herbal formula called HKIIM-KU can lower uric acid levels and reduce gout attacks. Adults with gout will take either the herbal granules or a placebo twice daily for 8 weeks. The goal is to see if this traditional remedy offers a safer alternative to standard gout medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental Chinese herbal formula called HKIIM-KU
- What this could lead to
- If effective, this herbal formula could offer a new, well-tolerated option for managing gout and preventing flare-ups.
- What could go wrong
- This is an early phase 2 trial with only 80 participants, so results may not apply broadly. Herbal formulas can vary in potency and may still cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
80 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient meeting the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2015 gout classification criteria (met sufficient criterion\* or total score ≥8) ; 2. History of \>=1 self-reported flare of gouty arthritis within 12 months prior to randomization; 3. Agree to undergo blood test and willing to complete questionnaires and take medications as scheduled; and 4. Agree to participate in the study and provide written informed consent. (for those illiterate subjects, their family member can sign the consent form upon subject's agreement) Note: \* Sufficient criterion = Presence of MSU crystals in a symptomatic joint or bursa (i.e., in synovial fluid) or tophus Exclusion Criteria: 1. Liver-kidney yin deficiency pattern according to Chinese medicine theory; 2. Use of urate-lowering drugs within 2 weeks prior to screening; 3. Present of tophi or known history of kidney stones. 4. Known use of oral/injectable corticosteroids or other Chinese herbal medicine for treating gout within 1 month prior to screening; 5. Ongoing acute gout arthritis flare at screening or within 2 weeks prior to screening; 6. History of \>4 flares overall in the 12 months prior to screening. 7. Polyarticular gouty arthritis involving more than 4 joints; 8. Severe deformity, stiffness and labor loss of patients with advanced arthritis; 9. Known rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis; 10. Known history of any serious diseases such as severe kidney and liver impairments, autoimmune disease, thyroid disease, Hodgkin's disease, lymphoma, severe mental disorders and leukemia 11. Known presence or suspicion of acute infectious disease; 12. Known history of malignancy within the past 5 years; 13. Known allergic to the drug used in this study; 14. Documented pregnant or lactation; 15. Subjects participating in other clinical studies at the same time.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Chinese University of Hong Kong
Shatin, Hong Kong
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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