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

NCT05257174 | Unknown

• 1 other identifier: IRB110-301-A
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in disease activity of inflammatory arthritis [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]

  Change of disease activity every 4 weeks until 12 weeks after Jing Si Herbal Tea Liquid Packets

Study Arms (2)

Jing Si Herbal Tea LIQUID PACKETS

EXPERIMENTAL

one packet oral twice daily for three months

Dietary Supplement: Jing Si Herbal Tea LIQUID PACKETS

Placebo

PLACEBO COMPARATOR

one packet oral twice daily for three months

Dietary Supplement: Placebo

Interventions

Jing Si Herbal Tea LIQUID PACKETS DIETARY_SUPPLEMENT

intake Jing Si Herbal Tea LIQUID PACKETS twice daily for three months

Jing Si Herbal Tea LIQUID PACKETS

Placebo DIETARY_SUPPLEMENT

intake Placebo twice daily for three months

Placebo

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• inflammatory arthritis, any of the following diagnosis
• Rheumatoid arthritis, based on ACR (American College of Rheumatology) classification criteria
• Ankylosing spondylitis, based on modified New York Criteria
• Psoriatic arthritis, based on 2006 CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria

You may not qualify if:

• active infection or chronic infection
• uncontrolled disease status of inflammatory arthritis
• unwilling to take herbal tea
• with difficulty for return visits

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, 970, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 26272057 BACKGROUND

• 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.

  PMID: 32745130 BACKGROUND

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Fatigue

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kuei-Ying Su, MD,PhD

  Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 25, 2022
• Study Start: June 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.

Locations

TW (1)