Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03983408
Other study ID # HUHRD-SPE-19-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 17, 2019
Est. completion date September 30, 2020

Study information

Verified date June 2020
Source Hanyang University
Contact Yoon-Kyoung Sung, MD, PhD, MPH
Phone 82-2-2290-9250
Email sungyk@hanyang.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of a randomized, double-blind, placebo-controlled trial and open-label extension study is to figure out the impact of Korean Red Ginseng (KRG) on fatigue in patients with rheumatic diseases.


Description:

Primary objective

: Improvement of fatigue after using KRG in patients with rheumatic diseases according to

Secondary objectives

1. Improvement of dryness after using KRG in patients with rheumatic diseases according to EULAR Sjögren's syndrome disease activity index (ESSDAI)

2. Improvement of quality of life after using KRG in patients with rheumatic diseases according to EuroQol 5 dimensions questionnaire (EQ-5D)

The study population will be adult patients with rheumatic diseases, especially primary or secondary Sjögren's syndrome who have experienced dryness for more than 3 months. Participants are ramdomly assigned to KRG and placebo group and they are using KRG or placebo for the first 12 weeks. After 12 weeks, the concealment of allocation is lifted and all patients are provided with KRG for next 12 weeks with open-label extension study


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 30, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients who meet for Classification Criteria for Sjögren's syndrome

- Patients who have experienced fatigue for over 3 months

- Patients aged = 19 and <75

- Patients who provide a written consent of participating in this study.

Exclusion Criteria:

- Patients who have experienced hypersensitivity or adverse events to Korean Red ginseng

- Patients who used dietary supplements containing KRG during recent 2 months

- Patients who are pregnant or breast-feeding

- Patients who use oral glucocorticoids or opioids continuously

- Patients who had other comorbidities which could lead to fatigue as symptoms including chronic kidney disease, chronic liver disease, endocrine disoders, malignancy, or depression.

- Patients having fibromyalgia or chronic fatigue syndrome

- Patients who presented abnormal laboratory findings at the time of enrollment White blood cell (WBC) = 3.5 x 10^9/L or, Hemoglobin (Hb) = 8.5 g/dL or, Platelet (PLT) = 100 x 10^9/L or, Serum creatinine (Cr) = 2.0 mg/dL or, Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) = 2.5 times of upper limits of normal

Study Design


Intervention

Dietary Supplement:
Korean Red Ginseng
Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
Placebo
Placebo tablets, made of corn starch and cellulose, are manufactured to mimic KRG tablets. Participants are parovided with 2 placebo tablets twice a day for first 12 weeks, following Korean Red Ginseng extract tablets twice a day for another 12 weeks.

Locations

Country Name City State
Korea, Republic of Hanyang University Seoul

Sponsors (2)

Lead Sponsor Collaborator
Hanyang University The Korean Society of Ginseng

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Cho SK, Kim D, Yoo D, Jang EJ, Jun JB, Sung YK. Korean Red Ginseng exhibits no significant adverse effect on disease activity in patients with rheumatoid arthritis: a randomized, double-blind, crossover study. J Ginseng Res. 2018 Apr;42(2):144-148. doi: 10.1016/j.jgr.2017.01.006. Epub 2017 Jan 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue) Improvement of FACIT-F after using KRG 12 weeks
Secondary Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued]) Improvement of FACIT-VAS after using KRG 12 weeks
Secondary ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity) Improvement of ESSDAI after using KRG 12 weeks
Secondary EuroQol 5 dimensions questionnaire (EQ-5D, a person's health status is defined by a 5-digit number, ranging from 11111 [having no problems in all dimensions] to 33333 [having extreme problems in all dimensions]) Improvement of EQ-5D after using KRG 12 weeks
See also
  Status Clinical Trial Phase
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT04042792 - Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate
Recruiting NCT05554029 - Coronaphobia in Rheumatic Diseases N/A
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Completed NCT02694796 - Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy N/A
Completed NCT02256098 - RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA N/A
Completed NCT02269254 - Persona Versus NexGen N/A
Completed NCT00642837 - A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets Phase 4
Active, not recruiting NCT04704544 - Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis (EVOLVE) N/A
Completed NCT05026853 - Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice N/A
Active, not recruiting NCT04631965 - Healthcare Transition of Adolescents With Chronic Health Conditions
Recruiting NCT00024479 - Natural History of Rheumatic Diseases in Minority Communities
Completed NCT05031104 - Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis N/A
Not yet recruiting NCT04567576 - Predictive Factors for COVID-19 in Rheumatology
Completed NCT02291471 - Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers Phase 1
Completed NCT01227694 - Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis Phase 1/Phase 2
Recruiting NCT01071447 - Nurse-led Clinic for Patients With Rheumatic Diseases and Biological Treatment N/A
Active, not recruiting NCT05618782 - Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee Phase 2
Active, not recruiting NCT05543642 - The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd) Phase 4
Active, not recruiting NCT02694185 - Secondary Event Prevention Using Population Risk Management After PCI and for Anti-Rheumatic Medications N/A