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

• Register: ChiCTR
• Last refreshed on: 30 September 2019
• Main ID: ChiCTR1900026257
• Date of registration: 2019-09-28
• Prospective Registration: Yes
• Primary sponsor: Zhejiang Provincal Hospital of TCM
• Public title: A Randomized, Double-Blind Clinical Trial for Effect of Wisconsin Ginseng (Panax quinquefolius) in Improvement of Rheumatoid Arthritis Associated Fatigue
• Scientific title: Efficacy, dose comparison, and safety of Wisconsin Ginseng (Panax quinquefolius) in patients with rheumatoid arthritis associated fatigue: Three-arm parallel, multicenter, randomized, double-blind, placebo-controlled, phase 2 trial
• Date of first enrolment: 2019-09-28
• Target sample size: High-dose experimental group :30;Low-dose experimental group:30;Control group :30;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=43807
• Study type: Interventional study
• Study design: Parallel
• Phase: 2

Countries of recruitment

China

Contacts

• Name: ERIC EUGENE VANDENHOUTEN
• Affiliation: Zhejiang Chinese Medical University International Education College

• Name: SONG XINWEI
• Affiliation: Zhejiang Provincal Hospital of TCM

Key inclusion & exclusion 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: (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;

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis (RA)

Intervention(s)

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) ;

Primary Outcome(s)

Rheumatoid factor (RF);Anti-cyclic citrullinated peptide (anti-CCP);Visual analogue scale to evaluate fatigue severity (VAS-F);

Secondary Outcome(s)

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);

Source(s) of Monetary Support

Zhejiang department of science and technology major science and technology projects

Ethics review

Status: Approved
Approval date: 22/07/2019
Contact:

Cao Yi