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

NCT01774877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2014-12-19

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • liu jiu, doctor · The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-06-30
Completion
2014-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774877 on ClinicalTrials.gov