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

Buddhist Tzu Chi General Hospital

Status: Invitation-only

Conditions: Arthritis; Psoriatic Arthritis; Fatigue; Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Dietary Supplement: Jing Si Herbal Tea LIQUID PACKETS; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05257174

IRB110-301-A

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Jing Si Herbal Tea LIQUID PACKETS

Experimental group

Description:

one packet oral twice daily for three months

Treatment:

Dietary Supplement: Jing Si Herbal Tea LIQUID PACKETS

Placebo

Placebo Comparator group

Description:

one packet oral twice daily for three months

Treatment:

Dietary Supplement: Placebo