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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 20 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05436938
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Buddhist Tzu Chi General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Taiwan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

DLQI, PHQ-9, PSAI, Serum Cytokine Survey
Arms & Interventions

Arms

Experimental: Psoriasis patients with mild severity, treatment group

with Jing Si herbal tea liquid packets use

Placebo Comparator: Psoriasis patients with mild severity, placebo group

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

Placebo Comparator: Psoriasis patients with moderate to severe severity, placebo group

without Jing Si herbal tea liquid packets use

Interventions

Combination Product: - Jing Si herbal tea liquid packets use

with or without Jing Si herbal tea liquid packets use

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hualien Tzu Chi Hospital, Hualien City, Hualien, Taiwan

Status

Recruiting

Address

Hualien Tzu Chi Hospital

Hualien City, Hualien, 970

Site Contact

Sung Jen Sung Jen, PhD

[email protected]

886-912170913

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