A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng ( Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue

Abstract

INTERVENTION: High‐dose experimental group :6000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ;Low‐dose experimental group:3000mg Wisconsin ginseng (Panax quinquefolius) herb intervention: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg); 3000mg Placebo: 1500mg, orally, twice daily (bid) Capsule (3 capsules / 500mg) ;Control group :6000mg Placebo: 3000mg, orally, twice daily (bid) Capsule (6 capsules / 500mg) ; CONDITION: Rheumatoid arthritis (RA) PRIMARY OUTCOME: Rheumatoid factor (RF);Anti‐cyclic citrullinated peptide (anti‐CCP);Visual analogue scale to evaluate fatigue severity (VAS‐F); SECONDARY OUTCOME: 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); 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.