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

Brief Title

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

Official Title

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

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.
    



Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Arthritis

Intervention

Jing Si Herbal Tea LIQUID PACKETS

Study Arms / Comparison Groups

 Jing Si Herbal Tea LIQUID PACKETS
Description:  one packet oral twice daily for three months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

150

Start Date

June 15, 2022

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Kuei-Ying Su, MD,PhD, 886-38561825, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT05257174

Organization ID

IRB110-301-A


Responsible Party

Sponsor

Study Sponsor

Buddhist Tzu Chi General Hospital


Study Sponsor

Kuei-Ying Su, MD,PhD, Principal Investigator, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation


Verification Date

January 2022