NCT05257174

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Buddhist Tzu Chi General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Jing Si Herbal Tea LIQUID PACKETS	intake Jing Si Herbal Tea LIQUID PACKETS twice daily for three months
DIETARY_SUPPLEMENT	Placebo	intake Placebo twice daily for three months

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-12-31
• Completion: 2024-06-01
• First posted: 2022-02-25
• Last updated: 2023-07-27

Locations

1 site across 1 country: Taiwan