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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03983408
Study type Interventional
Source Hanyang University
Contact Yoon-Kyoung Sung, MD, PhD, MPH
Phone 82-2-2290-9250
Email sungyk@hanyang.ac.kr
Status Recruiting
Phase N/A
Start date June 17, 2019
Completion date September 30, 2020

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