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A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines –the Second Trial

A 24 Week Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Chinese Medicines

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000989
Enrollment
Unknown
Registered
2010-08-05
Start date
2010-08-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

observation group:Methotrexate Tablets, once per week, for first tim
observation group:Leigongtengduogan Pian, 10mg per time, 3 times per day, Yishen Juanbi Wan, 8g per time, 3 times per day, for oral administration, after meals

Sponsors

The Ministry of Science and Technology of the People's Republic of China
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: TTo be enrolled, subjects must be between the age of 18 and 70, and has met the following conditions: a. Be diagnosed with RA as defined by the 1987 America College of Rheumatology (ACR) criteria, and the disease progression is in the I, II, or III phase, in active phase. b. Sign the informed consent by patient or guardian. c. Meet any one of the following conditions: (1) manifests any 2 of these symptoms simultaneously: clear urine in large amounts, spontaneous sweating, night sweat, deep pulse, chills, thirsty. (2) manifests any 2 of these symptoms simultaneously: slippery pulse, red tongue, greasy fur, abdominal distension. (3) manifests any 1 of these symptoms simultaneously: pale tongue, white fur.

Exclusion criteria

Exclusion criteria: Subjects who meed the inclusion criteria will be excluded from the study if the have any of the following: a. Meet any one of the following mentioned symptoms: (1) manifests any 2 of these symptoms simultaneously: thin pulse, string-like pluse, agitation, dizziness. (2) manifests any 2 of these symptoms simultaneously: yellow fur, bitter taste, febrile joints, frequent cold. (3) manifests any 1 of these symptoms simultaneously: purplish tongue, dark red tongue body. b. to combine with severe diseases in cardiovascular, lung, liver, renal, hematopoietic systems, or have to apply glucocorticoids for hyperpyrexia, interstitial pneumonia, renal amyloidosis, constrictive pericardium, central nervous system vasculitis, or to combine with gastrointestinal tract diseases in active phase, to have esophagus or enteron ulcers within 30 days before participating in this study (don’t exclude patients with alimentary tract hemorrhage history long before). c. to take the following drugs for a long-term till 1 month before participating in this study: glucocorticoids, chloroquine, sulfasalazine, cyclophosphamide, penicillamine, gold preparations, anticancer agent, and the patients who took Chinese medicine for RA till half a month before participating in this study. d. inaptitude for the clinical protocols, for example, being allergic to sulfanilamide. e. being involved in other clinical trials at present or 1 month before participating in this study. f. researchers in this study. g. women during pregnancy or lactation, or planning to get pregnant. h. mental patients.

Design outcomes

Primary

MeasureTime frame
Rest pain, pressing pain on joints, arthrocele, ea;

Secondary

MeasureTime frame
Laboratory examinations: ESR, RF, CRP, IgA, IgG, I;Pattern information of Chinese Medicine (symptoms;

Countries

China

Contacts

Public ContactAiping Lu
lap64067611@126.com+86 10 64067611

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 28, 2026