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

Primary Purpose

Acute Gouty Arthritis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Acute gouty arthritis, tonifying spleen and descending the turbid, soaking, wet wrapping

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-75, and gender unlimited;
  2. The patients must meet western medicine diagnostic criteria for acute gouty arthritis;
  3. 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:

  1. 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.
  2. Acute infectious diseases, stroke, acute myocardial infarction ,as well as other acute diseases and tumors, rheumatoid arthritis.
  3. Patients with peptic ulcer and gastrointestinal bleeding.

Sites / Locations

  • No.3 Hospital Affiliated to Beijing University of Chinese MedicineRecruiting
  • Dongzhimen Hospital Affiliated to Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

treatment group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
The gout relief index
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.
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
Recurrence rate=number of patient recurring acute gouty arthritis ÷total cases of each group.The unit of measure is number.
Recurrence time
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
The unit of measure is mg.
Blood uric acid before and after the treatment.
White blood cell count before and after the treatment.
Erythrocyte sedimentation rate before and after the treatment.

Full Information

First Posted
September 2, 2015
Last Updated
September 10, 2015
Sponsor
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02545777
Brief Title
The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gouty Arthritis
Keywords
Acute gouty arthritis, tonifying spleen and descending the turbid, soaking, wet wrapping

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.
Intervention Type
Drug
Intervention Name(s)
diclofenac sodium enteric-coated
Intervention Type
Drug
Intervention Name(s)
Oral medicine of tonifying spleen and descending turbid
Intervention Description
Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae
Intervention Type
Drug
Intervention Name(s)
Steeping and washing medicine of descending turbid and clearing heat
Intervention Description
Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones
Intervention Type
Drug
Intervention Name(s)
Wet wrapping medicine of descending turbid and clearing heat
Intervention Description
Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
Primary Outcome Measure Information:
Title
The relief of symptoms
Description
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.
Time Frame
After take the drug 10 days
Title
The gout relief index
Description
The gout relief index = [gout relief time (days) ÷ 10 (days)] x 100%.The unit of measure is scale.
Time Frame
After take the drug 10 days
Title
Compare scores of syndrome before treatment and after it.
Description
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.
Time Frame
After take the drug 10 days
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence rate=number of patient recurring acute gouty arthritis ÷total cases of each group.The unit of measure is number.
Time Frame
Following up for 1 month
Title
Recurrence time
Description
Compare the days of cases recurring acute gouty arthritis of each group.The unit of measure is days.
Time Frame
Following up for 1 month
Title
The dosage of colchicine of two groups in observation period
Description
The unit of measure is mg.
Time Frame
After take the drug 10 days
Title
Blood uric acid before and after the treatment.
Time Frame
After take the drug 10 days
Title
White blood cell count before and after the treatment.
Time Frame
After take the drug 10 days
Title
Erythrocyte sedimentation rate before and after the treatment.
Time Frame
After take the drug 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Shi Dong, Doctor
Phone
13910965659
Email
wsd3122@sina.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Wen Jing, Master
Phone
15201218433
Email
anna861029@163.com
Facility Information:
Facility Name
No.3 Hospital Affiliated to Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lou Xi Nen, Doctor
Phone
13601181885
Email
13601181885@163.com
Facility Name
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Jiu Li, Doctor
Phone
84013229
Email
dzmk@163.net

12. IPD Sharing Statement

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

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