Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease

June 7, 2020 updated by: Yoon-Kyoung Sung, Hanyang University
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.

Study Overview

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: KRG group
  • Enrollment: 60 patients
  • Drug: Korean Red Ginseng (KRG) 2,000 mg/day for total 24 weeks (2 Korean Red Ginseng extract tablet twice a day, ginsenoside Rg1+Rb1+Rg3 7.0 mg/g per each tablet)
Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
Other Names:
  • KRG
Placebo Comparator: Placebo group
  • Enrollment: 60 patients
  • Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)
Time Frame: 12 weeks
Improvement of FACIT-F after using KRG
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued])
Time Frame: 12 weeks
Improvement of FACIT-VAS after using KRG
12 weeks
ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity)
Time Frame: 12 weeks
Improvement of ESSDAI after using KRG
12 weeks
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])
Time Frame: 12 weeks
Improvement of EQ-5D after using KRG
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yoon-Kyoung Sung, MD, PhD, MPH, Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

June 10, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (Actual)

June 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 7, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD is not shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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