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

NCT ID: NCT05436938

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-06-30

Brief Summary

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

Conditions

DLQI; PHQ-9; PSAI; Serum Cytokine Survey

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psoriasis patients with mild severity, treatment group

with Jing Si herbal tea liquid packets use

Group Type: EXPERIMENTAL

Jing Si herbal tea liquid packets use

Intervention Type: COMBINATION_PRODUCT

with or without Jing Si herbal tea liquid packets use

Psoriasis patients with mild severity, placebo group

without Jing Si herbal tea liquid packets use

Group Type: PLACEBO_COMPARATOR

Jing Si herbal tea liquid packets use

Intervention Type: COMBINATION_PRODUCT

with or without Jing Si herbal tea liquid packets use

Psoriasis patients with moderate to severe severity, treatment goup

with Jing Si herbal tea liquid packets use

Group Type: EXPERIMENTAL

Jing Si herbal tea liquid packets use

Intervention Type: COMBINATION_PRODUCT

with or without Jing Si herbal tea liquid packets use

Psoriasis patients with moderate to severe severity, placebo group

without Jing Si herbal tea liquid packets use

Group Type: PLACEBO_COMPARATOR

Jing Si herbal tea liquid packets use

Intervention Type: COMBINATION_PRODUCT

with or without Jing Si herbal tea liquid packets use

Interventions

Jing Si herbal tea liquid packets use

with or without Jing Si herbal tea liquid packets use

Intervention Type: COMBINATION_PRODUCT

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung-Jen Hung

Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hualien Tzu Chi Hospital

Hualien City, Hualien, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Sung Jen Hung, PhD

Role: CONTACT

md.hong@msa.hinet.net

886-912170913

research ethics committee Hualien tzu chi hospital

Role: CONTACT

886-3-8561825 ext. 12124

Facility Contacts

Sung Jen Sung Jen, PhD

Role: primary

md.hong@msa.hinet.net

886-912170913

Other Identifiers

TCMF-JCT 111-08

Identifier Type: -

Identifier Source: org_study_id