Oral Huzhang Granules for Acute Gouty Arthritis

Gouty Arthritis Clinical Trial

Official title:

Oral Huzhang Granules for Acute Gouty Arthritis: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04462666
• Other study ID #: 2020024
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2020
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Bin Li
• Phone: 0086-021-55981301
• Email: 18930568129[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Gout is a recurrent chronic inflammatory disease caused by monosodium urate (MSU) crystal . Acute gouty arthritis (GA) is the most common first symptom of gout. With the progress of the disease, the frequency of acute attack increases, and joint destruction may occur. The prevalence of hyperuricemia in China was about 13.3%, and the pooled prevalence of gout was 1.1%. Repeated attacks of GA seriously affect the quality of life, resulting in huge economic costs and mental stress. Due to inadequate prevention and treatment, the target of healing gout is often not achieved. In GA, TCM has shown satisfactory therapeutic effect with less adverse effects and minimal toxicity. Huzhang granule (HZG), a Chinese herbal prescription, is a compound preparation with twelve ingredients which has been used in the clinical treatment of gout for over 30 years at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of TCM.Therefore，this double-blind, randomized, controlled clinical trial. will provide high-quality clinical evidences for evaluating the clinical efficacy, safety and control of recurrence rate of Huzhang granule ，a representative prescription for the treatment of acute gouty arthritis , in the treatment of GA.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 267
• Est. completion date: August 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of acute gout arthritis as defined by the American College of Rheumatology 1977 preliminary criteria;

• Male or non-pregnant, non-nursing female;

• 18-70 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;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Gouty Arthritis

Intervention

Drug:
• Huzhang granule
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.
• Etoricoxib
take one capsule per day in the morning, at approximately 30 minutes after the meal.
• Huzhang granule Placebo
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.
• Etoricoxib Placebo
take one capsule per day in the morning, at approximately 30 minutes after the meal.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Likert scales for the assessment of joint tenderness and swelling	Likert scales for the assessment of joint tenderness and swelling is evaluate the inflammatory response and the degree of injury of the joint.Scores range from 1-5, a higher score indicating a severe symptoms on a participant's joint	Up to 5 days after treatment
Secondary	symptom relief time	Symptom relief time is the time when joint pain feels relieved	Up to 5 days after treatment
Secondary	36-Item Short Form Survey	36-Item Short Form Survey is a health status profile originally designed to measure eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.; Scoring the 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key in a given table. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. another lists the items averaged together to create each scale. Items that are left blank (missing data) are not taken into account when calculating	Up to 5 days after treatment