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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Sjögren's Syndrome Rheumatic Diseases Korean Red Ginseng

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Korean Red Ginseng

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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Korean Red Ginseng

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

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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KRG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No