ITMCTR2000004037
Not yet recruiting
Phase 1
Clinical study for the prevention and treatment of rheumatoid arthritis by Modified Hua-Yu Qiang-Shen Tong-Bi Decoction
Guangdong Provincial Hospital of Chinese Medicine0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects of the study shall meet the following diagnostic criteria:
- •(1\) the 2010 ACR/EULAR diagnostic criteria for RA;
- •(2\) The diagnostic criteria of TCM syndromes referS to the Guideline for Diagnosis and Treatment of Rheumatoid Arthritis combined with Syndrome and Syndrome Classification issued by The Chinese Society of Traditional Chinese Medicine in 2019\. TCM syndrome differentiation is characterized by cold damp Bi syndrome and wind damp Bi syndrome;
- •2\. According to DAS28\-CRP score, patients with low activity level of the disease (DAS28\-CRP 2\.6 to 3\.2\);
- •3\. Aged 18 to 70 years;
- •4\. The X\-ray grade of both hands is level II or below;
- •5\. if subjects take oral glucocorticoids, the dose must be stabilized to a dose \<\=10mg/ d of prednisone for at least 4 weeks prior to enrollment;
- •6\. If subjects use NSAIDs or other analgesics to treat RA, they must have received a stable dose for at least 1 week before enrollment;
- •7\. Written informed consent to participate in the study signed by the subject or his/her family member (guardian).
Exclusion Criteria
- •(1\) Those who had previously taken tripterygium wilfordii preparation, total glucoside capsules of Paeoniae alba, immunosuppression (such as salazosulfopyridine, D\-penicillamine, azathioprine, chloroquine, hydroxychloroquine, cyclosporine, mycophenolate mofel, tacrolimus, elamodide, cyclophosphamide) and biological agents for less than 4 weeks after drug withdrawal; Those who had received flunomide within 12 weeks before enrollment; Had received interferon therapy within 4 weeks prior to enrollment or was expected to require interferon therapy during the study period; Those who have been vaccinated with live vaccine within 2 weeks before enrollment or need to be immunized with live vaccine during the trial period; Intraarticular injection, intramuscular injection, or intravenous glucocorticoid including adrenotrophic hormone were administered 12 weeks before enrollment;
- •(2\) pregnancy, breastfeeding and recent family planning;
- •(3\) Patients with serious diseases of vital organs such as cardiovascular, brain, liver, lung, kidney and hematopoietic system, acute or chronic infectious diseases, malignant tumors and mental diseases; Other autoimmune diseases such as systemic lupus erythematosus overlap; Active fibromyalgia may pose difficulties in accurately evaluating the activity of RA in this study. Preexisting pulmonary interstitial changes: 12\-lead electrocardiogram (ECG) abnormalities at screening that the investigator or sponsor considers to be clinically significant and may pose an unacceptable risk to the patient's participation in the study;
- •(4\) Allergic to methotrexate tablets;
- •(5\) the laboratory screening test value has any of the following specific abnormalities: AST or ALT\>1\.2 times ULN; Hemoglobin \< 90\.0g /L; Total white blood cell count \<3\.5x10^9/L; Thrombocytopenia (platelet count \<100x10^9/L); Creatinine \>1\.6 ULN;
- •(6\) Those who are participating in other trials or have participated in other drug clinical trials within 2 months.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Phase 1
Clinical study for the prevention and treatment of rheumatoid arthritis by Hua-Yu Qiang-Shen Tong-Bi DecoctioRheumatoid ArthritisITMCTR1900002806Guangdong Provincial Hospital of Chinese Medicine
Not yet recruiting
Phase 1
Clinical study on the prevention and treatment of gastrointestinal dysfunction after lumbar internal fixation by percutaneous acupoint electrical stimulatioPostoperative gastrointestinal dysfunctionITMCTR2200005798Wangjing Hospital, China Academy of Chinese Medical Sciences
Recruiting
Phase 1
Clinical study on the prevention and treatment of nausea and vomiting after general anesthesia with domestic wearable transcutaneous acupoint electric stimulation bracelet: a prospective randomized trialPostoperative nausea and vomitingITMCTR2000003168Shanghai Changzheng Hospital
Recruiting
Phase 1
Clinical study on the prevention and treatment of colorectal adenoma by regulating intestinal microecology: a randomized double-blind controlled trialITMCTR2000003350Shuguang Hospital affillated with Shanghai University of TCM
Not yet recruiting
Not Applicable
A randomized, controlled , double-blind clinical study on the prevention and treatment of peripheral neurotoxicity of oxaliplatin by Danggui Sini granuleITMCTR2000004124Jiangsu Province Hospital on Integration Chinese and Western Medicine