Acute GoutPhase 3NCT02674776
Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout
A Phase 3 study testing HuZhen Capsule in people with Acute Gout, run by Quan Jiang at 1 site in China.
Trial summary
This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Gout
- What is being tested?
- HuZhen Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Jun 2017
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
- Acute attack of gout no longer than 2 days.
- Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
- Age 18-65 years with informed consent.
Who cannot join
- Chronic gouty arthritis.
- Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
- Anti-inflammatory medication for the treatment of acute gout.
- Pregnant or breastfeeding women.
- History of severe allergy, including diclofenac sodium.
- Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
- Fever ( T>38.5 ℃)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial About the Efficacy and Safety of HuZhen Capsule in Treating Patients With Acute Gout: A 72 Hours, Multi-center, Randomized, Double-blind, Parallel Placebo Compared Clinical Trial
This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.
Read the detailed description
The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.
- Conditions
- Acute Gout
- Being tested
- HuZhen Capsule, Placebo Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuZhen CapsuleDrug
Also called capsule A
Patients should take 4 tablet once and 3 times per day for 3 days.
Placebo CapsuleDrug
Also called capsule B
Patients should take 4 tablet once and 3 times per day for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| HuZhen Capsule | Experimental | The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc. Receives: Drug: HuZhen Capsule |
| Placebo Capsule | Placebo comparator | Placebo appearance, content color and taste should be consistent with HuZhen Capsule. Receives: Drug: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
Measured: baseline,72 hours
Secondary outcomes (5)
Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention
Refer to the"Guidline for Clinical Study of New Chinese Medicines "
Measured: 72 hours
Change in C-reactive protein (CRP) from baseline to 72 hours
Units of Measure:mg/L
Measured: baseline,72 hours
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours
Units of Measure:mm/hour
Measured: baseline,72 hours
Change in white blood cell count in whole blood cell analysis from baseline to 72 hours
Measured: baseline,72 hours
The number of adverse events related to treatment
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GoutStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quan Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiang Quan, Doctor, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674776
- Sponsor's protocol ID
- 2013003P3A03
- Status last verified
- Jun 2016
- First submitted
- 28 Jan 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial About the Efficacy and Safety of HuZhen Capsule in Treating Patients With Acute Gout: A 72 Hours, Multi-center, Randomized, Double-blind, Parallel Placebo Compared Clinical Trial
- ClinicalTrials.gov ID
- NCT02674776
- Acronym / sponsor ID
- 2013003P3A03
- Conditions
- Acute Gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Quan JiangUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- 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.
This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.
Detailed description
The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HuZhen Capsule | Experimental | Drug: HuZhen CapsuleThe main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc. |
| Placebo Capsule | Placebo comparator | Drug: Placebo CapsulePlacebo appearance, content color and taste should be consistent with HuZhen Capsule. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
- Acute attack of gout no longer than 2 days.
- Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
- Age 18-65 years with informed consent.
Key exclusion criteria (7 listed)
- Chronic gouty arthritis.
- Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
- Anti-inflammatory medication for the treatment of acute gout.
- Pregnant or breastfeeding women.
- History of severe allergy, including diclofenac sodium.
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 |
|---|---|---|
| HuZhen CapsuleAlso: capsule APatients should take 4 tablet once and 3 times per day for 3 days. | Drug | HuZhen Capsule |
| Placebo CapsuleAlso: capsule BPatients should take 4 tablet once and 3 times per day for 3 days. | Drug | Placebo Capsule |
Primary outcome
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
Time frame: baseline,72 hours
5 secondary outcomes
Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention
Time frame: 72 hours
Change in C-reactive protein (CRP) from baseline to 72 hours
Time frame: baseline,72 hours
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours
Time frame: baseline,72 hours
Change in white blood cell count in whole blood cell analysis from baseline to 72 hours
Time frame: baseline,72 hours
The number of adverse events related to treatment
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- 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.
Jiang Quan, Doctor principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HuZhen Capsule in people with Acute Gout, run by Quan Jiang at 1 site in China.
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 4 inclusion and 7 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 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset (time frame: baseline,72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2016.