The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029599
• Other study ID #: China.JLMXFYQ2008-01
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2013
• Last updated: October 7, 2015
• Start date: March 2014

Study information

• Verified date: October 2015
• Source: Maoxiang Group Jilin Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi granules in subjects with Rheumatoid Arthritis.

Description:

Fang yi qing feng shi granules is the chinese patent medicine, which contains 8 kinds of chinese medicine .

Fang yi qing feng shi granules was approved by China Food and Drug Administration (CFDA) in 2005, produced by means of modern technology by Maoxiang Group Jilin Pharmaceutical Co., Ltd.The study is a multi-center, double -blind, placebo -controlled, randomized in Chinese subjects with Rheumatoid Arthritis to assess treatment effect and safety in the subjects treated with Fang yi qing feng shi granules versus subjects treated with placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Subjects have the diagnosis of Rheumatoid Arthritis in active state.

2. Subjects have the Traditional Chinese Medicine (TCM) diagnosis ofArthralgic Syndrome with the sign of dampness obstructing connecting vessel?

3. Subjects must stop the medicine at least three month,which is Diseases modifying anti-rheumatic drugs(including glucocorticoids).

4. Male or female subjects, between the ages of 18 and 65 years old.

5. Joint function grading and ray classification are both in ?~?.

6. Subjects agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Subjects with systemic lupus erythematosus,sicca syndrome, or severe osteoarthropathy will be excluded.

2. Subjects with severe rheumatic arthritis are loss of ability

3. Allergic to test drugs(basic treatment or drug combination),Allergic constitution(Allergic to two or more drugs).

4. Female subject who was pregnant or breast-feeding or considering becoming pregnant.

5. Subjects with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.

6. The Liver function (ALT,AST) and kidney function(BUN,Cr)is higher than normal.

7. The Blood Routine (leukocyte count,platelet count)is lower than normal.

8. Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Fang yi qing feng shi granule
10g, Oral,Three each time, 3 times a day,for 3 months;
• placebo
10g, Oral,Three each time, 3 times a day,for 3 months
• Methotrexate
7.5-15mg per week,All patients should be used
• Acetaminophen tablets
Oral,0.5g, 1~2 times a day, when vas=10

Locations

Country	Name	City	State
China	LONGHUA Hospital Shanghai University of TCM	Shanghai	Shanghai
China	Hospital of Liaoning University of Traditional Chinese Medicine	Shenyang	Liaoning
China	First Teaching hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Second affiliated hospital of Tianjin university of tcm	Tianjin	Tianjin
China	Hubei provincial hospital of tcm	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Maoxiang Group Jilin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of Therapeutic effect with American College of Rheumatology standards (ACR)		Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	No
Secondary	The change of Rheumatoid Arthritis (RA) associated symptoms and signs	The symptoms and signs include "Tender joint count,swollen joint count,time of morning stiffness,mean grip strength, VAS score,Jint function"	Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	No
Secondary	Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests		Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	Yes
Secondary	The subjects of their comprehensive evaluation of disease activity(AIMS),The observer to the comprehensive evaluation of disease activity in the study(AIMS),The subjects of physical function evaluation(HAQ).		Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	No
Secondary	The change of laboratory test indexes (ESR?RF?CRP)		baseline,week12	No
Secondary	Traditional Chinese Medicine(TCM) characteristics evaluative index: Traditional Chinese medicine Syndrome Scale		Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	No
Secondary	The score of clinical symptoms and symptom integral		Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	No
Secondary	Change in the days and doses using of analgesic(Paracetamol Tablets)		Taken at day 1 (baseline) and Change from Baseline in 4th,8th,12th week	No