Brief Title
The Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis
Brief Summary
Fatigue is a common feature in patients with rheumatic conditions. Fatigue can lead to a
decline in physical function, self-confidence, cognitive status, and work performance and
significantly impact the quality of life. While pain and inflammation of arthritis can be
well controlled nowadays attributed to the advances in anti-rheumatic medications, fatigue
remains a challenge. Even with proper therapies for arthritis, the prevalence of severe
fatigue is more than 30%, which is a significant burden to both physicians and patients.
However, there is no regimen to alleviate fatigue among patients with inflammatory arthritis.
Finding a way to combat fatigue will significantly help improve patients' physical and mental
state and family society.
To investigate the efficacy of Jing Si Herbal Tea Liquid Packets on fatigue in patients with
inflammatory arthritis, the investigators propose a two-year research project to recruit
approximately 150 patients with fatigue and inflammatory arthritis, including rheumatoid
arthritis, ankylosing spondylitis, and psoriatic arthritis. This project is designed as a
randomized, double-blind, placebo-controlled study. The recruited patients will be randomized
to receive Jing Si Herbal Tea Liquid Packets or a matching placebo in combination with the
background regular anti-rheumatic therapy. The severity of fatigue will be obtained by
questionnaire. Clinical parameters, including demographic data and disease activities, will
be collected during each visit.
Study Type
Interventional
Primary Outcome
Change in level of fatigue [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]
Secondary Outcome
Change in disease activity of inflammatory arthritis [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]
Condition
Arthritis
Intervention
Jing Si Herbal Tea LIQUID PACKETS
Study Arms / Comparison Groups
Jing Si Herbal Tea LIQUID PACKETS
Description: one packet oral twice daily for three months
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
150
Start Date
June 15, 2022
Completion Date
December 2023
Primary Completion Date
December 2023
Eligibility Criteria
Inclusion Criteria:
- inflammatory arthritis, any of the following diagnosis
1. Rheumatoid arthritis, based on ACR (American College of Rheumatology)
classification criteria
2. Ankylosing spondylitis, based on modified New York Criteria
3. Psoriatic arthritis, based on 2006 CASPAR (ClASsification criteria for Psoriatic
ARthritis) criteria
Exclusion Criteria:
1. active infection or chronic infection
2. uncontrolled disease status of inflammatory arthritis
3. unwilling to take herbal tea
4. with difficulty for return visits
Gender
All
Ages
20 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Kuei-Ying Su, MD,PhD, 886-38561825, [email protected]
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT05257174
Organization ID
IRB110-301-A
Responsible Party
Sponsor
Study Sponsor
Buddhist Tzu Chi General Hospital
Study Sponsor
Kuei-Ying Su, MD,PhD, Principal Investigator, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Verification Date
January 2022