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

Rheumatoid Arthritis Clinical Trial

Official title:

Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774877
• Other study ID #: 2012BAI26B02
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: December 17, 2014
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Xinfeng capsule
Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months; placebo(for leflunomide):10mg each time, 1 time a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
• leflunomide
leflunomide :10mg each time, one time a day, Oral,for 3 months; placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry

Locations

Country	Name	City	State
China	The first affiliated hospital of bengbu medical college	Bengbu	Anhui
China	The first affiliated hospital of anhui medical university	Hefei	Anhui
China	Yijishan Hospital of Wannan Medical College	Wuhu	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )	ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA).	baseline,week4,week8,week12	No
Secondary	ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms )	ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).	baseline,week4,week8,week12	No
Secondary	ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms )	ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).	baseline,week4,week8,week12	No
Secondary	Patterns based on Chinese medicine(CM)symptoms		baseline,week4,week8,week12	No
Secondary	Disease Activity Scale (DAS)28		baseline,week4,week8, week12	No
Secondary	Rheumatoid arthritis (RA) biomarkers	Rheumatoid arthritis (RA) biomarkers,including rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) ,anti-cyclic citrullinated peptide (anti-CCP) antibodies, IgG?IgA?IgM, d-dimer, the coagulation function tests	baseline, week12	Yes
Secondary	Life Quality Assessment	Life Quality Assessment,including Health Assessment Questionnaire (HAQ), Self-rating depression scale(SDS), Self-rating anxiety scale(SAS),quality of life Questionnaire with rheumatoid arthritis.	baseline,week12	No
Secondary	x-rays of the hands and wrists		baseline,week12	No