Acute Gouty ArthritisPhase 2NCT02545777
The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid
A Phase 2 study testing diclofenac sodium enteric-coated, Oral medicine of tonifying spleen and descending turbid and Steeping and washing medicine of descending turbid and clearing heat in people with Acute Gouty Arthritis, run by Beijing University of Chinese Medicine at 2 sites in China.
Trial summary
This research is based on spleen trapped by dampness and turbid which is the pathogenesis of gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In this study, the investigators use multi-center randomized parallel controlled clinical trials.The treatment groups are afforded oral… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Gouty Arthritis
- What is being tested?
- diclofenac sodium enteric-coated, Oral medicine of tonifying spleen and descending turbid and Steeping and washing medicine of descending turbid and clearing heat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- May 2014to Dec 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75, and gender unlimited;
- The patients must meet western medicine diagnostic criteria for acute gouty arthritis;
- The patients must meet that integral syndrome differentiation conforms to the spleen beset by dampness syndrome and local syndrome differentiation conforms to blockage disease due to heat.
Who cannot join
- Secondary hyperuricemia, such as cancer and perichemotherapy of leukemia, renal failure, cirrhosis of the liver and drug effect(such as diuretics, aspirin, antitubercular agents), et al.
- Acute infectious diseases, stroke, acute myocardial infarction ,as well as other acute diseases and tumors, rheumatoid arthritis.
- Patients with peptic ulcer and gastrointestinal bleeding.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
No.3 Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100029
Lou Xi Nen, Doctor, 13601181885, 13601181885@163.com
- Recruiting
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700
Zhao Jiu Li, Doctor, 84013229, dzmk@163.net
About this study
This research is based on spleen trapped by dampness and turbid which is the pathogenesis of gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In this study, the investigators use multi-center randomized parallel controlled clinical trials.The treatment groups are afforded oral traditional Chinese medicine decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a positive control drug.The outcome is evaluated by condition of symptoms remission,pain relief time, recurrence rate and laboratory index to determine the efficacy of internal and external treatment.And the research will provide optimized diagnosis and treatment program. The investigators hope this research will also get tonifying spleen and descending the turbid internal and external treatment for gouty arthritis effective clinical treatment.
- Conditions
- Acute Gouty Arthritis
- Being tested
- diclofenac sodium enteric-coated, Oral medicine of tonifying spleen and descending turbid, Steeping and washing medicine of descending turbid and clearing heat, Wet wrapping medicine of descending turbid and clearing heat
- Keywords
- Acute gouty arthritis, tonifying spleen and descending the turbid, soaking, wet wrapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac sodium enteric-coatedDrug
Oral medicine of tonifying spleen and descending turbidDrug
Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae
Steeping and washing medicine of descending turbid and clearing heatDrug
Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones
Wet wrapping medicine of descending turbid and clearing heatDrug
Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | Take oral medicine of tonifying spleen and descending turbid, one bag each time, two times a day, continuous treatment for 10 days.The onset of the joints afford steeping washing and wet wrapping medicine of descending turbid and clearing heat, once per day, continuous treatment for 10 days. Receives: Drug: Oral medicine of tonifying spleen and descending turbid; Drug: Steeping and washing medicine of descending turbid and clearing heat; Drug: Wet wrapping medicine of descending turbid and clearing heat |
| Control group | Active comparator | Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days. Receives: Drug: diclofenac sodium enteric-coated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relief of symptoms
This measure is a composite outcome according to the joint red and swollen, joint pain, and restricted movement(Excellent:Complete resolution of symptoms, joint function returning to normal. The score of joint pain, joint red and swollen and joint motion is 0.Effective:The main symptoms mostly disappear. Joint function is improvement, but still have the joint red,swollen,pain and limited activity.Invalid: There is no improvement compared with before treatment).The unit of measure is scale.
Measured: After take the drug 10 days
The gout relief index
The gout relief index = [gout relief time (days) ÷ 10 (days)] x 100%.The unit of measure is scale.
Measured: After take the drug 10 days
Compare scores of syndrome before treatment and after it.
Using nimodipine method: nimodipine = [(scores of syndrome before treatment minus score after it) ÷scores of syndrome before treatment] x 100%.The unit of measure is scale.
Measured: After take the drug 10 days
Secondary outcomes (6)
Recurrence rate
Recurrence rate=number of patient recurring acute gouty arthritis ÷total cases of each group.The unit of measure is number.
Measured: Following up for 1 month
Recurrence time
Compare the days of cases recurring acute gouty arthritis of each group.The unit of measure is days.
Measured: Following up for 1 month
The dosage of colchicine of two groups in observation period
The unit of measure is mg.
Measured: After take the drug 10 days
Blood uric acid before and after the treatment.
Measured: After take the drug 10 days
White blood cell count before and after the treatment.
Measured: After take the drug 10 days
Erythrocyte sedimentation rate before and after the treatment.
Measured: After take the drug 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Shidong, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545777
- Sponsor's protocol ID
- 2015-ZYLC-001
- Status last verified
- Sep 2015
- First submitted
- 2 Sep 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid
- ClinicalTrials.gov ID
- NCT02545777
- Acronym / sponsor ID
- 2015-ZYLC-001
- Conditions
- Acute Gouty Arthritis
- Keywords
- Acute gouty arthritis, tonifying spleen and descending the turbid, soaking, wet wrapping
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 10 Sep 2015 (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 research is based on spleen trapped by dampness and turbid which is the pathogenesis of gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In this study, the investigators use multi-center randomized parallel controlled clinical trials.The treatment groups are afforded oral traditional Chinese medicine decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a positive control drug.The outcome is evaluated by condition of symptoms remission,pain relief time, recurrence rate and laboratory index to determine the efficacy of internal and external treatment.And the research will provide optimized diagnosis and treatment program. The investigators hope this research will also get tonifying spleen and descending the turbid internal and external treatment for gouty arthritis effective clinical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Drug: Oral medicine of tonifying spleen and descending turbid, Drug: Steeping and washing medicine of descending turbid and clearing heat, Drug: Wet wrapping medicine of descending turbid and clearing heatTake oral medicine of tonifying spleen and descending turbid, one bag each time, two times a day, continuous treatment for 10 days.The onset of the joints afford steeping washing and wet wrapping medicine of descending turbid and clearing heat, once per day, continuous treatment for 10 days. |
| Control group | Active comparator | Drug: diclofenac sodium enteric-coatedTake diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-75, and gender unlimited;
- The patients must meet western medicine diagnostic criteria for acute gouty arthritis;
- The patients must meet that integral syndrome differentiation conforms to the spleen beset by dampness syndrome and local syndrome differentiation conforms to blockage disease due to heat.
Key exclusion criteria (3 listed)
- Secondary hyperuricemia, such as cancer and perichemotherapy of leukemia, renal failure, cirrhosis of the liver and drug effect(such as diuretics, aspirin, antitubercular agents), et al.
- Acute infectious diseases, stroke, acute myocardial infarction ,as well as other acute diseases and tumors, rheumatoid arthritis.
- Patients with peptic ulcer and gastrointestinal bleeding.
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 |
|---|---|---|
| diclofenac sodium enteric-coated | Drug | Control group |
| Oral medicine of tonifying spleen and descending turbidIngredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae | Drug | treatment group |
| Steeping and washing medicine of descending turbid and clearing heatIngredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones | Drug | treatment group |
| Wet wrapping medicine of descending turbid and clearing heatIngredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones. | Drug | treatment group |
Primary outcome
The relief of symptoms
Time frame: After take the drug 10 days
This measure is a composite outcome according to the joint red and swollen, joint pain, and restricted movement(Excellent:Complete resolution of symptoms, joint function returning to normal. The score of joint pain, joint red and swollen and joint motion is 0.Effective:The main symptoms mostly disappear. Joint function is improvement, but still have the joint red,swollen,pain and limited activity.Invalid: There is no improvement compared with before treatment).The unit of measure is scale.
The gout relief index
Time frame: After take the drug 10 days
The gout relief index = [gout relief time (days) ÷ 10 (days)] x 100%.The unit of measure is scale.
Compare scores of syndrome before treatment and after it.
Time frame: After take the drug 10 days
Using nimodipine method: nimodipine = [(scores of syndrome before treatment minus score after it) ÷scores of syndrome before treatment] x 100%.The unit of measure is scale.
6 secondary outcomes
Recurrence rate
Time frame: Following up for 1 month
Recurrence time
Time frame: Following up for 1 month
The dosage of colchicine of two groups in observation period
Time frame: After take the drug 10 days
Blood uric acid before and after the treatment.
Time frame: After take the drug 10 days
White blood cell count before and after the treatment.
Time frame: After take the drug 10 days
Erythrocyte sedimentation rate before and after the treatment.
Time frame: After take the drug 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diclofenac sodium enteric-coated, Oral medicine of tonifying spleen and descending turbid and Steeping and washing medicine of descending turbid and clearing heat in people with Acute Gouty Arthritis, run by Beijing University of Chinese Medicine at 2 sites 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 3 inclusion and 3 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 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 Wang Shi Dong, Doctor (13910965659, wsd3122@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relief of symptoms (time frame: After take the drug 10 days). The study lists 3 primary outcomes in all. 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 11 Sep 2015.