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

Hanyang University

Status: Unknown

Conditions: Sjögren's Syndrome; Rheumatic Diseases; Korean Red Ginseng

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Korean Red Ginseng

Study type: Interventional

Funder types: Other

Identifiers

NCT03983408

HUHRD-SPE-19-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

KRG group

Active Comparator group

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)

Treatment:

Dietary Supplement: Korean Red Ginseng

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo