A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-16008793
• Date of registration: 2016-06-10
• Prospective Registration: Yes
• Primary sponsor: The First Affiliated Hospital of Third Military Medical University
• Public title: A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis
• Scientific title: A multi center, randomized, double blind, positive parallel controlled clinical study of Zhengqing Fengtongning sustained release tablets in the treatment of rheumatoid arthritis
• Date of first enrolment: 2016-07-15
• Target sample size: experimental group:80; control group:80;The combined treatment group:80;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=12905
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: ZOU QINGHUA
• Affiliation: The First Affiliated Hospital of Third Military Medical University

• Name: FANG YONGFEI
• Affiliation: The First Affiliated Hospital of Third Military Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1) to know the whole process of the experiment, voluntarily participate in and sign the informed consent form;
2) in accordance with the 1987 ACR or 2010 ACR rheumatoid arthritis classification criteria for the diagnosis of RA patients;
3) men and women aged 18 to 75 years old;
4) in patients with mild to moderate, 2.65) no severe systemic involvement, such as severe pericardial effusion, pulmonary interstitial disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, and so on.
Exclusion criteria: 1) pregnant women, pregnant or lactating women;
2) liver disease activity period or liver function abnormal, AST, ALT is the upper limit of the normal value 1.5 times or more;
3) renal function damage, blood creatinine is higher than the upper limit of the normal value;
4) the subjects' blood white blood cells < 3 * 10^9/L, or have a clear anemia (hemoglobin is less than 80g/L), or platelet < 80 * 109/L, or have other blood system diseases;
5) with active peptic ulcer disease in recent 1 years;
6) uncontrolled severe hypertension, metabolic diseases (such as diabetes) patients;
7) patients with malignant tumor;
8) suffering from acute and / or chronic infectious diseases;
9) ECG examination of severe arrhythmia;
(10) previous use of the drug (positive wind pain Ning, methotrexate) have adverse reactions;
11) have mental disorders, alcoholism, drug or other substance abusers;
12) had a diagnosis of other connective tissue disease;
13) prior use of biological agents, Zhengqingfengtongning, methotrexate or related preparation, discontinuation of <4 weeks;
14) with a variety of other investigators that can not be added to this clinical trial;
15) to participate in other clinical studies in the past 15 months.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis

Intervention(s)

experimental group:ZHENGQING FENGTONGNING sustained release tablets; control group:methotrexate;The combined treatment group:ZHENGQING FENGTONGNING sustained release tablets combine methotrexate;

Primary Outcome(s)

The proportion of subjects who reached the ACR20 standard at the 24th week;

Secondary Outcome(s)

The proportion of subjects reach DAS28 score of 2.6 or less at each Visit;At each visit the proportion of subjects reach the remission of CDAI and SDAI criteria (CDAI = 2.8, SDAI =3.3);The proportion of subjects who reached the ACR20 standard at each follow-up time;The proportion of subjects who had Rheumatoid factor and anti CCP antibody decreased;

Source(s) of Monetary Support

Hunan Zheng Qing Pharmaceutical Group Limited by Share Ltd