To Evaluate the Mechanism of Jing Si Herbal Tea Liquid Packets and Traditional Western Medicine for Psoriasis

June 23, 2022 updated by: Sung-Jen Hung, Buddhist Tzu Chi General Hospital

Psoriasis is a chronic cutaneous inflammatory disease due to immune dysregulation. It caused skin lesions with thickening plaques and heavy silver scales over the patient's body surface area, including nail deformity, often accompanied by severe itching and pain. Psoriasis is not a contagious or infectious skin disorder, but patients' quality of life is often severely affected by skin symptoms. The annual prevalence of psoriasis in Taiwan is about 0.235%, and about one in 500 people may get psoriasis. Psoriasis has not just skin problems, but it often combines with other comorbidities such as psoriatic arthritis, metabolic syndrome such as diabetes, hypertension, hyperlipidemia and obesity, cardiovascular diseases such as stroke or ischemic heart disease, liver and kidney diseases, inflammatory bowel disease, iritis, and mental illness related to emotional stress and depression. Therefore, patients with psoriasis should regularly receive appropriate therapies to prevent complications and comorbidities. The current standard treatments for psoriasis include traditional topical and systemic treatments, phototherapy, and biologics. Traditional Chinese herbal medicine is also an alternative treatment for psoriasis due to considerable benefits and lower toxicity. Chinese medicine still plays a vital role in the treatment of psoriasis in Taiwanese societies. This experiment will further explore the anti-inflammatory effect of Jing-Si-Herbal-Tea combined with traditional western medicine for three months to reduce inflammatory mediators in the skin and blood and improve the disease severity and quality of life for psoriatic patients.

key words：Psoriasis, Psoriatic arthritis, Comorbidities, Treatment, Jing-Si-Herbal-Tea, Chinese medicine

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: research ethics committee Hualien tzu chi hospital
  • Phone Number: 12124 886-3-8561825

Study Locations

  • Taiwan
    • Hualien
      • Hualien City, Hualien, Taiwan, 970
        • Recruiting
        • Hualien Tzu Chi Hospital
        • Contact:
        • Principal Investigator:
          • Sung Jen Sung Jen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- • Subjects were able to give informed consent prior to commencing any trial-related assessments or procedures.

  • Subjects were at least 20 years old when they signed the informed consent form.
  • At the time of inclusion in this trial, subjects had to have a diagnosis of chronic psoriasis by a dermatologist.
  • According to Taiwan's regulations and payment policies, subjects will or have received treatment related to psoriasis. Before being included in the trial, physicians will independently determine the course of treatment with western medicine related to psoriasis.
  • The subjects can communicate well with the trial host and understand the contents of the trial case, and follow the trial specifications.
  • At the start of the trial, subjects were willing to provide a three-month trial follow-up to record psoriasis severity and dermatological quality of life questionnaires.

Exclusion Criteria:

  • The subject is unwilling or unable to comply with the requirements of the trial.
  • Subject participated in an interventional clinical trial at this time or within the past 30 days. However, participation in another PMOS (post-marketing observational trial) or registration trial is acceptable.
  • Those who are judged by physicians to be infirm, allergic, cold, chronic disease, poor renal function, children under the age of three, children, pregnant, breastfeeding, menstrual period are not suitable to participate in this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Psoriasis patients with mild severity, treatment group
with Jing Si herbal tea liquid packets use
Combination product: Jing Si herbal tea liquid packets use
with or without Jing Si herbal tea liquid packets use
PLACEBO_COMPARATOR: Psoriasis patients with mild severity, placebo group
without Jing Si herbal tea liquid packets use
Combination product: Jing Si herbal tea liquid packets use
with or without Jing Si herbal tea liquid packets use
EXPERIMENTAL: Psoriasis patients with moderate to severe severity, treatment goup
with Jing Si herbal tea liquid packets use
Combination product: Jing Si herbal tea liquid packets use
with or without Jing Si herbal tea liquid packets use
PLACEBO_COMPARATOR: Psoriasis patients with moderate to severe severity, placebo group
without Jing Si herbal tea liquid packets use
Combination product: Jing Si herbal tea liquid packets use
with or without Jing Si herbal tea liquid packets use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psoriasis Area and Severity Index (PASI)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Dermatology Life Quality Index (DLQI)
Time Frame: 3 months
3 months
Patient Health Questionnaire (PHQ)-9
Time Frame: 3 months
3 months
serum cytokine profiles
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2022

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (ACTUAL)

June 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCMF-JCT 111-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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