- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05436938
To Evaluate the Mechanism of Jing Si Herbal Tea Liquid Packets and Traditional Western Medicine for Psoriasis
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sung Jen Hung, PhD
- Phone Number: 886-912170913
- Email: md.hong@msa.hinet.net
Study Contact Backup
- Name: research ethics committee Hualien tzu chi hospital
- Phone Number: 12124 886-3-8561825
Study Locations
-
-
Hualien
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Hualien City, Hualien, Taiwan, 970
- Recruiting
- Hualien Tzu Chi Hospital
-
Contact:
- Sung Jen Sung Jen, PhD
- Phone Number: 886-912170913
- Email: md.hong@msa.hinet.net
-
Principal Investigator:
- Sung Jen Sung Jen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
|
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
|
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
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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