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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Jian, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01774877
First received: January 22, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Drug: Xinfeng capsule
Drug: leflunomide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Xinfeng Capsule in the Treatment of Rheumatoid Arthritis (RA):A Randomized, Double-blind, Double-dummy, Multi-center Trial

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms ) [ Time Frame: baseline,week4,week8,week12 ] [ Designated as safety issue: No ]
    ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA).


Secondary Outcome Measures:
  • ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms ) [ Time Frame: baseline,week4,week8,week12 ] [ Designated as safety issue: No ]
    ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

  • ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms ) [ Time Frame: baseline,week4,week8,week12 ] [ Designated as safety issue: No ]
    ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

  • Patterns based on Chinese medicine(CM)symptoms [ Time Frame: baseline,week4,week8,week12 ] [ Designated as safety issue: No ]
  • Disease Activity Scale (DAS)28 [ Time Frame: baseline,week4,week8, week12 ] [ Designated as safety issue: No ]
  • Rheumatoid arthritis (RA) biomarkers [ Time Frame: baseline, week12 ] [ Designated as safety issue: Yes ]
    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

  • Life Quality Assessment [ Time Frame: baseline,week12 ] [ Designated as safety issue: No ]
    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.

  • x-rays of the hands and wrists [ Time Frame: baseline,week12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 304
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xinfeng capsule & placebo
  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
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
Active Comparator: leflunomide & placebo
  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
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774877

Contacts
Contact: Liu Jian, Doctor 86-055162838582 liujianahzy@yahoo.com.cn

Locations
China, Anhui
The first affiliated hospital of bengbu medical college Recruiting
Bengbu, Anhui, China, 233004
Contact: Li Zhijun    86-0552-3065724      
The first affiliated hospital of anhui medical university Recruiting
Hefei, Anhui, China, 230031
Contact: Xu Jianhua    86-0551-62922016      
Yijishan Hospital of Wannan Medical College Recruiting
Wuhu, Anhui, China, 241001
Contact: li yan    86-0553-5738279      
Sponsors and Collaborators
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Ministry of Science and Technology of the People´s Republic of China
Investigators
Principal Investigator: liu jiu, doctor The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  More Information

No publications provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liu Jian, professor,Chief Physician, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01774877     History of Changes
Other Study ID Numbers: 2012BAI26B02
Study First Received: January 22, 2013
Last Updated: July 30, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine:
xinfeng capsule;
rheumatoid arthritis (RA);
randomized;
double-blind;

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014