Gouty ArthritisPhase 2NCT04462666
Oral Huzhang Granules for Acute Gouty Arthritis
A Phase 2 study testing Huzhang granule and Etoricoxib in people with Gouty Arthritis, run by Shanghai Yueyang Integrated Medicine Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gouty Arthritis
- What is being tested?
- Huzhang granule and Etoricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Oral Huzhang Granules for Acute Gouty Arthritis: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial
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
Read the detailed 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.
- Conditions
- Gouty Arthritis
- Being tested
- Huzhang granule, Etoricoxib, Huzhang granule Placebo, Etoricoxib Placebo
- Keywords
- Gouty arthritis, Randomized controlled trial, Huzhang granule, Traditional Chinese medicine
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huzhang granuleDrug
Also called Chinese Herbal Medicine
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.
EtoricoxibDrug
Also called Chemical drug
take one capsule per day in the morning, at approximately 30 minutes after the meal.
Huzhang granule PlaceboDrug
Also called Chinese Herbal Medicine
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 PlaceboDrug
Also called Chemical drug
take one capsule per day in the morning, at approximately 30 minutes after the meal.
| Study group | Role | What they receive |
|---|---|---|
| HZG intervention | Experimental | During 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. Receives: Drug: Huzhang granule; Drug: Etoricoxib Placebo |
| Etoricoxib intervention | Active comparator | During 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. Receives: Drug: Etoricoxib; Drug: Huzhang granule Placebo |
| Placebo intervention | Placebo comparator | During 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. Receives: Drug: Huzhang granule Placebo; Drug: Etoricoxib Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 5 days after treatment
Secondary outcomes (3)
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
Measured: Up to 5 days after treatment
symptom relief time
Symptom relief time is the time when joint pain feels relieved
Measured: Up to 5 days after treatment
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
Measured: Up to 5 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gouty ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, Study chair, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462666
- Sponsor's protocol ID
- 2020024
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35365187
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Huzhang Granules for Acute Gouty Arthritis: Protocol for a Randomized, Double-blind, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04462666
- Acronym / sponsor ID
- 2020024
- Conditions
- Gouty Arthritis
- Keywords
- Gouty arthritis, Randomized controlled trial, Huzhang granule, Traditional Chinese medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HZG intervention | Experimental | Drug: Huzhang granule, Drug: Etoricoxib PlaceboDuring 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 comparator | Drug: Etoricoxib, Drug: Huzhang granule PlaceboDuring 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 comparator | Drug: Huzhang granule Placebo, Drug: Etoricoxib PlaceboDuring 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huzhang granuleAlso: Chinese Herbal MedicineEmpty 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. | Drug | HZG intervention |
| EtoricoxibAlso: Chemical drugtake one capsule per day in the morning, at approximately 30 minutes after the meal. | Drug | Etoricoxib intervention |
| Huzhang granule PlaceboAlso: Chinese Herbal MedicineEmpty 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. | Drug | Etoricoxib intervention, Placebo intervention |
| Etoricoxib PlaceboAlso: Chemical drugtake one capsule per day in the morning, at approximately 30 minutes after the meal. | Drug | HZG intervention, Placebo intervention |
Primary outcome
Visual Analogue Score (VAS)
Time frame: Up to 5 days after treatment
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)
3 secondary outcomes
Likert scales for the assessment of joint tenderness and swelling
Time frame: Up to 5 days after treatment
symptom relief time
Time frame: Up to 5 days after treatment
36-Item Short Form Survey
Time frame: Up to 5 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 35365187Zhou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Zhou study chair
Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Huzhang granule and Etoricoxib in people with Gouty Arthritis, run by Shanghai Yueyang Integrated Medicine Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Li (0086-021-55981301, 18930568129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS) (time frame: Up to 5 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.