Back to results

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

Primary Purpose

Sjögren's Syndrome, Rheumatic Diseases, Korean Red Ginseng

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Korean Red Ginseng

Placebo

About this trial

This is an interventional supportive care trial for Sjögren's Syndrome focused on measuring Sjögren's Syndrome, Korean Red Ginseng

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hanyang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

KRG group

Placebo group

Arm Description

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)

Enrollment: 60 patients Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT03983408

First Posted

June 10, 2019

Last Updated

June 7, 2020

Sponsor

Hanyang University

Collaborators

The Korean Society of Ginseng

1. Study Identification

Unique Protocol Identification Number

NCT03983408

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

August 31, 2020 (Anticipated)

Study Completion Date

September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hanyang University

Collaborators

The Korean Society of Ginseng

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Primary objective : Improvement of fatigue after using KRG in patients with rheumatic diseases according to Secondary objectives Improvement of dryness after using KRG in patients with rheumatic diseases according to EULAR Sjögren's syndrome disease activity index (ESSDAI) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sjögren's Syndrome, Rheumatic Diseases, Korean Red Ginseng

Keywords

Sjögren's Syndrome, Korean Red Ginseng

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Masking Description

Allocation concealment for first 12 weeks is maintained; all participants are provided with KRG during during another 12 weeks for the open-label extension.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KRG group

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Enrollment: 60 patients Drug: Placebo for 12 weeks, following Korean Red Ginseng 2,000mg/day for another 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Korean Red Ginseng

Other Intervention Name(s)

KRG

Intervention Description

Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue)

Description

Improvement of FACIT-F after using KRG

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Visual analogue scale-Fatigue (VAS-F, total score ranged 0 [fatigued not at all] to 100 [extremely fatigued])

Description

Improvement of FACIT-VAS after using KRG

Time Frame

12 weeks

Title

ESSDAI (The EULAR Sjögren's syndrome [SS] disease activity index, total score ranged 0 to 123, higher scroes indicate severe systemic disease activity)

Description

Improvement of ESSDAI after using KRG

Time Frame

12 weeks

Title

Description

Improvement of EQ-5D after using KRG

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yoon-Kyoung Sung, MD, PhD, MPH

Phone

82-2-2290-9250

sungyk@hanyang.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoon-Kyoung Sung, MD, PhD, MPH

Organizational Affiliation

Hanyang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hanyang University

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoon-Kyoung Sung, MD, PhD, MPH

Phone

82-2-2290-9250

sungyk@hanyang.ac.kr

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD is not shared with other researchers

Citations:

PubMed Identifier

29719460

Citation

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs