The Effects of Jing Si Herbal Tea Liquid Packets on Fatigue in Patients With Inflammatory Arthritis

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

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 Overview

• Status: Enrolling by invitation
• Conditions: Fatigue; Arthritis; Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis
• Intervention / Treatment: Dietary supplement: Jing Si Herbal Tea LIQUID PACKETS; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hualien City, Taiwan, 970
    • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jing Si Herbal Tea LIQUID PACKETS; one packet oral twice daily for three months	Dietary supplement: Jing Si Herbal Tea LIQUID PACKETS; intake Jing Si Herbal Tea LIQUID PACKETS twice daily for three months
Placebo Comparator: Placebo; one packet oral twice daily for three months	Dietary supplement: Placebo; intake Placebo twice daily for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of fatigue [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]	Fatigue assessment measured by the functional assessment of chronic illness Therapy- Fatigue (FACIT- F) (0-52; higher score=less fatigue)	Change of fatigue level every 4 weeks until 12 weeks after Jing Si Herbal Tea Liquid Packets

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in disease activity of inflammatory arthritis [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]	Disease activity of inflammatory arthritis measured by the Disease Activity Score based on 28 joints (DAS28) (0-9.55; higher score=more active) for rheumatoid arthritis, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (0-10; higher score=more active) for ankylosing spondylitis, and Disease Activity in PSoriatic Arthritis (DAPSA) (0-204; higher score=more active) for psoriatic arthritis.	Change of disease activity every 4 weeks until 12 weeks after Jing Si Herbal Tea Liquid Packets

Collaborators and Investigators

• Sponsor: Buddhist Tzu Chi General Hospital
• Investigators: Principal Investigator: Kuei-Ying Su, MD,PhD, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Publications and helpful links

General Publications

• Overman CL, Kool MB, Da Silva JA, Geenen R. The prevalence of severe fatigue in rheumatic diseases: an international study. Clin Rheumatol. 2016 Feb;35(2):409-15. doi: 10.1007/s10067-015-3035-6. Epub 2015 Aug 15.
• Esbensen BA, Stallknecht SE, Madsen ME, Hagelund L, Pilgaard T. Correlations of fatigue in Danish patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis. PLoS One. 2020 Aug 3;15(8):e0237117. doi: 10.1371/journal.pone.0237117. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Psoriasis; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Fatigue; Arthritis; Arthritis, Psoriatic; Spondylitis; Spondylitis, Ankylosing
• Other Study ID Numbers: IRB110-301-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in fatigue among patients with inflammatory arthritis. Data or samples shared will be coded, with no PHI (protected health information) included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No