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NCT Number: NCT01774877

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affiliated hospital of bengbu medical college, Bengbu, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xinfeng capsule

Drug

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

Drug

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

Primary outcomes

  1. ACR20 (American College of Rheumatology (ACR) criteria of 20% improvement in symptoms )

    Time frame: baseline,week4,week8,week12

    ACR20 used for evaluating the efficacy of rheumatoid arthritis (RA).

Secondary outcomes

  1. ACR50 (American College of Rheumatology (ACR) criteria of 50% improvement in symptoms )

    Time frame: baseline,week4,week8,week12

    ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

  2. ACR70 (American College of Rheumatology (ACR) criteria of 70% improvement in symptoms )

    Time frame: baseline,week4,week8,week12

    ACR50 used for evaluating the efficacy of rheumatoid arthritis (RA).

  3. Patterns based on Chinese medicine(CM)symptoms

    Time frame: baseline,week4,week8,week12

  4. Disease Activity Scale (DAS)28

    Time frame: baseline,week4,week8, week12

  5. Rheumatoid arthritis (RA) biomarkers

    Time frame: baseline, week12

    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

  6. Life Quality Assessment

    Time frame: baseline,week12

    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.

  7. x-rays of the hands and wrists

    Time frame: baseline,week12

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Other

Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2013
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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