Rheumatoid arthritis (RA)
Conditions
Interventions
Sponsors
Zhejiang Provincal Hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with rheumatoid arthritis (RA): (1) Patients meeting the diagnostic criteria for the 2010 ACR/EULAR Classification Criteria for Rheumatoid Arthritis, American society of rheumatology and European society of rheumatology RA classification criteria; (2) Aged 18-70 years; (3) General health status is determined by medical history and physical examination; (4) The subject can understand and voluntarily participate in the study and sign the informed consent; (5) Subjects with a history of RA related fatigue; (6) Subject agrees to comply with the requirements of the protocol; (7) Be able to attend all site visits; 2. With 'qi and yin' deficiency of TCM zhen.
Exclusion criteria
Exclusion criteria: (1) Exclusion criteria: (1.1)Subjects with uncontrollable pain; (1.2)Gestation less than 37 weeks; (1.3)A history of any of the following: allergy to any vaccine or drug, or allergy to any ingredient of ginseng; (1.4)A family history of congenital, epileptic or progressive neurological diseases; (1.5)Severe malnutrition; (1.6)Major congenital defects or serious chronic diseases, including perinatal brain injury, splenic insufficiency or splenectomy; (1.7)Had any rheumatoid arthritis complications in the last 6 months; (1.8)Bleeding disorder diagnosed by the doctor, or obvious bruising or bleeding difficulty due to immediate injection or blood drawing; (1.9)Any acute infection within the last 7 days; (1.10)Whether you have received ginseng herbal treatment in the past 2 months; (1.11)Have used blood products in the past 3 months; (1.12)Have used other research drugs in the past month; (1.13)Use of attenuated vaccines within the past 15 days; (1.14)Inactivated vaccines have been used in the past 7 days; (1.15)Receive TB prevention or treatment; History of asthma, vasoneural edema, diabetes or malignant tumor; Thyroidectomy, or thyroid disease in the past 12 months; (1.16)Any circumstances considered by the researcher to be likely to interfere with the evaluation of the research objectives; (2) Exclusion criteria if any of the following occurs during treatment: (2.1)Any serious adverse reactions related to the intervention occurred within 7 days after the first injection; (2.2)Any confirmed or suspected human immunodeficiency virus (HIV) infection; (2.3)Allergic reactions after intervention of ginseng herbs; (2.4)Any conditions considered by the researcher or the IRB;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rheumatoid factor (RF);Anti-cyclic citrullinated peptide (anti-CCP);Visual analogue scale to evaluate fatigue severity (VAS-F); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Activity Score 28-joint count Erythrocyte sedimentation rate/C-reactive protein (DA S28ESR/CRP);The Health assessment questionnaire disability index (HAQ-DI);Erythrocyte sedimentation rate (ESR);C-reactive protein (CRP);Cyclic adenosine monophosphate (cAMP);Cyclic guanosine monophosphate (cGMP);Complete blood count (CBC);Hepatic function panel (LFT);Renal function panel (RFP); | — |
Countries
China
Contacts
Public ContactERIC EUGENE VANDENHOUTEN
Zhejiang Chinese Medical University International Education College
Outcome results
None listed