Oral Huzhang Granules for Acute Gouty Arthritis
1 other identifier
interventional
267
0 countries
N/A
Brief Summary
We designed this study as a double-blind, randomized, controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of acute gouty arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedJuly 8, 2020
July 1, 2020
3.1 years
June 30, 2020
July 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Score (VAS)
Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)
Up to 5 days after treatment
Secondary Outcomes (3)
Likert scales for the assessment of joint tenderness and swelling
Up to 5 days after treatment
symptom relief time
Up to 5 days after treatment
36-Item Short Form Survey
Up to 5 days after treatment
Study Arms (3)
HZG intervention
EXPERIMENTALDuring the 5-day treatment period, participants in the Experimental group will receive 10 sacks of experimental granules. They will be instructed to take two sacks per day, one in the morning and one in the evening, in approximately 30 minutes after the meal.. The placebo etoricoxib will also be taken daily in the morning for 5 days.
Etoricoxib intervention
ACTIVE COMPARATORDuring the 5-day treatment period, participants in the Etoricoxib group will receive 5 Etoricoxib capsules. They will be instructed to take one capsule per day in the morning, at approximately 30 minutes after the meal. The placebo HZKL will also be taken daily in the morning for 5 days.
Placebo intervention
PLACEBO COMPARATORDuring the 5-day treatment period, participants in the Placebo group will receive 10 sacks of placebo HZG. They will be instructed to take two sacks per day, one sack in the morning and one in the evening, at approximately 30 minutes after the meal. And the placebo etoricoxib also be taken daily in the morning for 5 days.
Interventions
Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
take one capsule per day in the morning, at approximately 30 minutes after the meal.
Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
take one capsule per day in the morning, at approximately 30 minutes after the meal.
Eligibility Criteria
You may qualify if:
- Diagnosis of acute gout arthritis as defined by the American College of Rheumatology 1977 preliminary criteria;
- Male or non-pregnant, non-nursing female;
- years of age;
- Gout attack less ≤48 hours;
- In the week before this observation, non-steroidal anti-inflammatory drugs and analgesic drugs and drugs affecting uric acid metabolism were not taken;
- Subjects capable of giving informed consent;
You may not qualify if:
- failing to meet the diagnostic criteria;
- Evidence of uncontrolled concomitant cardiovascular, nervous system,hepatic or gastrointestinal disease. Potential participants who have active concomitant disease can only be eligible after discussion and agreement with the treating medical team;
- the patient is in critical condition and it is difficult to evaluate the effectiveness and safety of the clinical observation;
- severe deformity, stiffness and labor loss of patients with advanced arthritis;
- known allergic to the drug used in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Zhou M, Hua L, Wang YF, Chen ST, Yang CM, Zhang M, Li X, Li B. Oral Huzhang granules for the treatment of acute gouty arthritis: protocol for a double-blind, randomized, controlled trial. Trials. 2022 Apr 1;23(1):248. doi: 10.1186/s13063-022-06188-x.
PMID: 35365187DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia Zhou
Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2020
First Posted
July 8, 2020
Study Start
July 1, 2020
Primary Completion
July 31, 2023
Study Completion
August 31, 2023
Last Updated
July 8, 2020
Record last verified: 2020-07