An Innovative Chinese Herbal Formula for the Treatment of Gout

NCT05499312 | Unknown Phase 2 DMC

• 1 other identifier: Gout Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Gout

Outcome Measures

Primary Outcomes (2)

• Serum uric acid

  Blood sample for serum uric acid (sUA) will be collected. It is regarded as a controllable factor that contributing to gout. Evidence showed that gout flare risk increases when a patient's sUA fails to achieve target level.

  week 4

• Serum uric acid

  Blood sample for serum uric acid (sUA) will be collected. It is regarded as a controllable factor that contributing to gout. Evidence showed that gout flare risk increases when a patient's sUA fails to achieve target level.

  week 8

Secondary Outcomes (19)

• Serum uric acid

  week 12

• Pain Visual Analogue Scale

  week 2

• Pain Visual Analogue Scale

  week 4

• Pain Visual Analogue Scale

  week 8

• Pain Visual Analogue Scale

  week 12

Study Arms (2)

HKIIM-KU formula

EXPERIMENTAL

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

Drug: HKIIM-KU formula

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HKIIM-KU formula DRUG

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

Also known as: HKIIM-KU

HKIIM-KU formula

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient meeting the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2015 gout classification criteria (met sufficient criterion\* or total score ≥8) ;
• History of \>=1 self-reported flare of gouty arthritis within 12 months prior to randomization;
• Agree to undergo blood test and willing to complete questionnaires and take medications as scheduled; and
• 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

You may not qualify if:

• Liver-kidney yin deficiency pattern according to Chinese medicine theory;
• Use of urate-lowering drugs within 2 weeks prior to screening;
• Present of tophi or known history of kidney stones.
• Known use of oral/injectable corticosteroids or other Chinese herbal medicine for treating gout within 1 month prior to screening;
• Ongoing acute gout arthritis flare at screening or within 2 weeks prior to screening;
• History of \>4 flares overall in the 12 months prior to screening.
• Polyarticular gouty arthritis involving more than 4 joints;
• Severe deformity, stiffness and labor loss of patients with advanced arthritis;
• Known rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis;
• 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
• Known presence or suspicion of acute infectious disease;
• Known history of malignancy within the past 5 years;
• Known allergic to the drug used in this study;
• Documented pregnant or lactation;
• Subjects participating in other clinical studies at the same time.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Zhixiu LIN, PhD

  Hong Kong Institute of Integrative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhixiu LIN, PhD

CONTACT

852-3943 6347; linzx@cuhk.edu.hk

Tak Yee CHOW, MSc

CONTACT

852-2873 3075; cmtychow@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: October 11, 2022
• Primary Completion: August 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

HK (1)