Trials / Unknown
UnknownNCT03983408
Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Hanyang University · Academic / Other
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Korean Red Ginseng | Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks. |
| 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. |
Timeline
- Start date
- 2019-06-17
- Primary completion
- 2020-08-31
- Completion
- 2020-09-30
- First posted
- 2019-06-12
- Last updated
- 2020-06-09
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03983408. Inclusion in this directory is not an endorsement.