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

Not Applicable

• Conditions: Fatigue; Arthritis; Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Jing Si Herbal Tea LIQUID PACKETS

• Registration Number: NCT05257174
• Lead Sponsor: Buddhist Tzu Chi General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-25
• Study Start: 2022-06-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-12-31
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	one packet oral twice daily for three months
Jing Si Herbal Tea LIQUID PACKETS	Jing Si Herbal Tea LIQUID PACKETS	one packet oral twice daily for three months

Primary Outcome Measures

Name	Time	Method
Change in level of fatigue [Time Frame: 4, 8, 12 weeks after Jing Si Herbal Tea Liquid Packets]	Change of fatigue level every 4 weeks until 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)

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; 🇨🇳 Hualien City, Taiwan