Clinical trial NCT01774877: A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome
Official title: Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: xinfeng capsule;
rheumatoid arthritis (RA);
randomized;
double-blind;
Lead sponsor: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2013-01-24
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )
timeFrame: baseline,week4,week8,week12
Secondary outcomes:
measure: ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms )
timeFrame: baseline,week4,week8，week12
measure: ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms )
timeFrame: baseline,week4,week8，week12
measure: Patterns based on Chinese medicine(CM)symptoms
timeFrame: baseline,week4,week8，week12
measure: Disease Activity Scale (DAS)28
timeFrame: baseline,week4,week8, week12
measure: Rheumatoid arthritis (RA) biomarkers
timeFrame: baseline, week12
measure: Life Quality Assessment
timeFrame: baseline,week12
measure: x-rays of the hands and wrists
timeFrame: baseline,week12
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college
state: Anhui
city: Hefei
country: China
facility: The first affiliated hospital of anhui medical university
state: Anhui
city: Wuhu
country: China
facility: Yijishan Hospital of Wannan Medical College
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: liu jiu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu J, Wang Y, Huang C, Xu J, Li Z, Xu L, He L, Sun Y, Wang Y, Xu S, Zhao P, Mao T, Tan B, Zhu F, Zhang P, Fang L. Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis: a multi-center parallel-group double-blind randomized controlled trial. J Tradit Chin Med. 2015 Oct;35(5):487-98. doi: 10.1016/s0254-6272(15)30130-8.
citation: Liu J, Huang CB, Wang Y, Xu GQ, Cheng YY, Feng YX, Liu L, Qi YJ. Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis: study protocol of a multicenter randomized controlled trial. J Integr Med. 2013 Nov;11(6):428-34. doi: 10.3736/jintegrmed2013059.