The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid

Sponsor

Beijing University of Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02545777

Collaborator

(none)

120

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Gouty Arthritis	Drug: diclofenac sodium enteric-coated 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	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

May 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: treatment group 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.	Drug: Oral medicine of tonifying spleen and descending turbid Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae Drug: Steeping and washing medicine of descending turbid and clearing heat Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones Drug: Wet wrapping medicine of descending turbid and clearing heat Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
Active Comparator: Control group Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.	Drug: diclofenac sodium enteric-coated

Arm

Intervention/Treatment

Active Comparator: treatment group

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.

Drug: Oral medicine of tonifying spleen and descending turbid

Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae

Drug: Steeping and washing medicine of descending turbid and clearing heat

Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones

Drug: Wet wrapping medicine of descending turbid and clearing heat

Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.

Active Comparator: Control group

Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.

Drug: diclofenac sodium enteric-coated

Outcome Measures

Primary Outcome Measures

The relief of symptoms [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 [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. [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.

Secondary Outcome Measures

Recurrence rate [Following up for 1 month]
Recurrence rate=number of patient recurring acute gouty arthritis ÷total cases of each group.The unit of measure is number.
Recurrence time [Following up for 1 month]
Compare the days of cases recurring acute gouty arthritis of each group.The unit of measure is days.
The dosage of colchicine of two groups in observation period [After take the drug 10 days]
The unit of measure is mg.
Blood uric acid before and after the treatment. [After take the drug 10 days]
White blood cell count before and after the treatment. [After take the drug 10 days]
Erythrocyte sedimentation rate before and after the treatment. [After take the drug 10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	No.3 Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing	China	100029
2	Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing	China	100700