A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: leflunomide; Drug: Xinfeng capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT01774877

2012BAI26B02

Details and patient eligibility

About

Bi Syndrome is one of Traditional Chinese Medicine（TCM）name, It means an obstruction in Chinese,and it refers the syndrome characterized by the obstruction of qi and blood in the meridians due to the invasion of external pathogenic wind,cold and dampness, manifested as soreness, pain, numb,etc. Bi Syndrome contains Rheumatoid arthritis(RA). RA is a chronic disease affecting more than 20 million people in the world.It is one of the most common forms of autoimmune disease. Xin'an Medicine is one of Traditional Chinese Medicine which originated from AnHui. Xinfeng Capsule developed according to the Xin'an medicine theory ,and it has long been adopted for treatment of rheumatoid arthritis (RA). The study is aimed to evaluate the effectiveness and safety of Xinfeng Capsule in the treatment of RA.

Enrollment: 304 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.
• According with the Zheng diagnosis of Traditional Chinese Medicine.
• age from 18 to 65 years.
• For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening，or Patients do not take NSAIDs at least 1 weeks prior to screening.
• Patients not taking DMARDs at least 4 weeks prior to screening.
• Patients taking corticosteroids (≤15mg prednisone or Equivalent) ≥4 weeks before entering the trial.
• Patients agree to participate in this study and sign the informed consent form.

Exclusion criteria

• Patients have received intra-articular or systemic corticosteroid injection within 4 weeks of screening.
• Patients have high disease activity (DAS28-3 scores> 5.1).
• Patients have diagnosed any other chronic inflammatory disease or connective tissue disease like sicca syndrome（SS）, systemic lupus erythematosus (SLE)etc;
• Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system ;
• Patients who are pregnant or nursing mothers or Psychiatric patients.
• Patients with active gastroduodenal ulcer or gastritis which caused by long-term use of NSAIDs;
• The patient who has known hypersensitivity to trial medicine .
• Patients have participated in other clinical trials within 4 weeks of screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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304 participants in 2 patient groups

Xinfeng capsule & placebo

Experimental group

Description:

1. Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months 2. placebo(for leflunomide): 10 mg each time, 1 time a day, Oral,for3 months

Treatment:

Drug: Xinfeng capsule

leflunomide & placebo

Active Comparator group

Description:

1. leflunomide :10mg each time, one time a day, by mouth,for 3 months 2. placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for3 months

Treatment:

Drug: leflunomide