A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Duhuo Jisheng Tang in The Treatment of Rheumatoid Arthritis by Regulating Lymphatic Drainage

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2020
INTERVENTION: Experimental group:Duhuo Jisheng Tang, MTX as base treatment.;Control group:Duhuo Jisheng Tang placebo, MTX as base treatment.; CONDITION: Rheumatoid Arthritis PRIMARY OUTCOME: Ultrasound;Disease activity scale: ACR20, ACR50, ACR70 and DAS28 ;X‐ray: Precise measurement of joint damage, the Van der Heijde Modified Sharp Score ;Inflammatory factors in peripheral blood ;NIR‐ICG:Detection of bilateral lymphatic vessels of the upper limb ;Ultrasound:Examination of the underside trochlear lymph node and axillary lymph nodes ;Lymphoid related factors in peripheral blood;Flow cytometry: peripheral blood;Whole transcriptome resequencing:peripheral blood;Metabonomics analysis of blood serum ; SECONDARY OUTCOME: HAQ‐DI(Health Assessment Questionnaire‐ Disability Index);Patient Assessment of Arthritis Pain;AIS Sleep Scale;SF‐36;syndrome of TCM; INCLUSION CRITERIA: 1. Patients who met the 1987 American College of Rheumatology diagnostic criteria for rheumatoid arthritis; 2. Patients who meet the criteria of liver and kidney deficiency type in the guidelines for diagnosis and treatment of rheumatoid arthritis of rheumatoid arthritis branch of Chinese society of traditional Chinese medicine in 2018; 3. Patients with DAS score above 2.6 and below 5.1; 4. Patients aged 18 and above, 70 and below; 5. Patients have the ability to communicate effectively with the researchers, understand and sign the informed consent, and ensure the compliance of the trial; 6. Women of childbearing age were confirmed to have no pregnancy and had no pregnancy plan during the whole trial period; 7. The chest X‐ray of the patient was normal.
Epistemonikos ID: e8deac64c6b7f26738fe84a0968c0a50f1943159
First added on: Mar 24, 2022