Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sjögren's Syndrome Rheumatic Diseases Korean Red Ginseng | Dietary Supplement: Korean Red Ginseng Dietary Supplement: Placebo | Not Applicable |
Primary objective
: Improvement of fatigue after using KRG in patients with rheumatic diseases according to
Secondary objectives
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
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. |
Primary Purpose: | Supportive Care |
Official Title: | Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease |
Actual Study Start Date : | June 17, 2019 |
Estimated Primary Completion Date : | August 31, 2020 |
Estimated Study Completion Date : | September 30, 2020 |
Arm | Intervention/treatment |
---|---|
Active Comparator: KRG group
|
Dietary Supplement: Korean Red Ginseng
Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
Other Name: KRG
|
Placebo Comparator: Placebo group
|
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.
|
Ages Eligible for Study: | 19 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yoon-Kyoung Sung, MD, PhD, MPH | 82-2-2290-9250 | sungyk@hanyang.ac.kr |
Korea, Republic of | |
Hanyang University | Recruiting |
Seoul, Korea, Republic of, 04763 | |
Contact: Yoon-Kyoung Sung, MD, PhD, MPH 82-2-2290-9250 sungyk@hanyang.ac.kr |
Principal Investigator: | Yoon-Kyoung Sung, MD, PhD, MPH | Hanyang University |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | June 10, 2019 | ||||
First Posted Date ICMJE | June 12, 2019 | ||||
Last Update Posted Date | June 9, 2020 | ||||
Actual Study Start Date ICMJE | June 17, 2019 | ||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F, total score ranged 0 to 52, higher scores respresent less fatigue) [ Time Frame: 12 weeks ] Improvement of FACIT-F after using KRG
|
||||
Original Primary Outcome Measures ICMJE |
The Functional Assessment of Chronic Illness-Fatigue (FACIT-F) [ Time Frame: 12 weeks ] Improvement of FACIT-F after using KRG
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE |
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease | ||||
Official Title ICMJE | Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease | ||||
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
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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) 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. Primary Purpose: Supportive Care
|
||||
Condition ICMJE |
|
||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
120 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 30, 2020 | ||||
Estimated Primary Completion Date | August 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 19 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
|
||||
Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03983408 | ||||
Other Study ID Numbers ICMJE | HUHRD-SPE-19-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Responsible Party | Yoon-Kyoung Sung, Hanyang University | ||||
Study Sponsor ICMJE | Hanyang University | ||||
Collaborators ICMJE | The Korean Society of Ginseng | ||||
Investigators ICMJE |
|
||||
PRS Account | Hanyang University | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |