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An Innovative Chinese Herbal Formula for the Treatment of Gout

NCT05499312 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-01-04

No results posted yet for this study

Summary

Gout is a chronic disease of deposition of monosodium urate crystals, which form in the presence of increased urate concentrations. Gout is closely related to hyperuricaemia. Urate deposits in the joint, causing joint swelling, pain, movement disorders, affecting a significant portion of the population worldwide annually.

The underlying pathophysiology of gout is multifactorial, complex, and poorly understood. Thus, gout remains one of the major therapeutic challenges. Currently, western medicine treatment of gout flare includes colchicine, NSAIDs and glucocorticoids. These drugs act as analgesics, anti-inflammatory and uric acid lowering drugs. Besides, management of gout and prevention of acute flares of gout make a crucial part in gout management. To obtain uricemia target, urate lowering treatment (ULT) has been widely used in conventional management of gout. Allopurinol, probenecid and febuxostat are some of the examples of ULT. Although researchers have carried out various studies on this disease, there are severe side effects for patients with gout. Therefore, it is necessary to explore new treatments for gout with good efficacy and less side effects.

Chinese medicine (CM) is nowadays widely used for managing gout in China and other East Asian countries. Our principal Investigator (Prof. Zhi-xiu Lin), a highly experienced Registered Chinese Medicine Practitioner working at the School of Chinese Medicine, The Chinese University of Hong Kong, has been using a herbal formula (HKIIM-KU formula) to treat patients with gout in Hong Kong for many years. This formula has been observed to be effective in relieving and preventing gout and its related clinical manifestations. Hence, a double-blind, randomized, placebo-controlled, multicenter clinical trial will be employed in this study, and it would be able to provide robust clinical evidence on the efficacy and safety of HKIIM-KU formula for gout.

Conditions

Interventions

DRUG

HKIIM-KU formula

Subjects will receive HKIIM-KU formula granules (16.9g twice daily) for 8 weeks.

DRUG

Placebo

Subjects will receive placebo granules (16.9g twice daily) for 8 weeks.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Zhixiu LIN, PhD · Hong Kong Institute of Integrative Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2024-08-31
Completion
2025-02-28

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05499312 on ClinicalTrials.gov