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

Primary Purpose

DLQI, PHQ-9, PSAI

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Jing Si herbal tea liquid packets use
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DLQI focused on measuring Psoriasis, Psoriatic arthritis, Comorbidities, Jing-Si-Herbal-Tea, Chinese medicine

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hualien Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Psoriasis patients with mild severity, treatment group

Psoriasis patients with mild severity, placebo group

Psoriasis patients with moderate to severe severity, treatment goup

Psoriasis patients with moderate to severe severity, placebo group

Arm Description

with Jing Si herbal tea liquid packets use

without Jing Si herbal tea liquid packets use

with Jing Si herbal tea liquid packets use

without Jing Si herbal tea liquid packets use

Outcomes

Primary Outcome Measures

Psoriasis Area and Severity Index (PASI)

Secondary Outcome Measures

Dermatology Life Quality Index (DLQI)
Patient Health Questionnaire (PHQ)-9
serum cytokine profiles

Full Information

First Posted
June 23, 2022
Last Updated
June 23, 2022
Sponsor
Buddhist Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05436938
Brief Title
To Evaluate the Mechanism of Jing Si Herbal Tea Liquid Packets and Traditional Western Medicine for Psoriasis
Official Title
To Evaluate the Mechanism of Jing Si Herbal Tea Liquid Packets and Traditional Western Medicine for Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DLQI, PHQ-9, PSAI, Serum Cytokine Survey
Keywords
Psoriasis, Psoriatic arthritis, Comorbidities, Jing-Si-Herbal-Tea, Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psoriasis patients with mild severity, treatment group
Arm Type
Experimental
Arm Description
with Jing Si herbal tea liquid packets use
Arm Title
Psoriasis patients with mild severity, placebo group
Arm Type
Placebo Comparator
Arm Description
without Jing Si herbal tea liquid packets use
Arm Title
Psoriasis patients with moderate to severe severity, treatment goup
Arm Type
Experimental
Arm Description
with Jing Si herbal tea liquid packets use
Arm Title
Psoriasis patients with moderate to severe severity, placebo group
Arm Type
Placebo Comparator
Arm Description
without Jing Si herbal tea liquid packets use
Intervention Type
Combination Product
Intervention Name(s)
Jing Si herbal tea liquid packets use
Intervention Description
with or without Jing Si herbal tea liquid packets use
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI)
Time Frame
3 months
Title
Patient Health Questionnaire (PHQ)-9
Time Frame
3 months
Title
serum cytokine profiles
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Jen Hung, PhD
Phone
886-912170913
Email
md.hong@msa.hinet.net
First Name & Middle Initial & Last Name or Official Title & Degree
research ethics committee Hualien tzu chi hospital
Phone
886-3-8561825
Ext
12124
Facility Information:
Facility Name
Hualien Tzu Chi Hospital
City
Hualien City
State/Province
Hualien
ZIP/Postal Code
970
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Jen Sung Jen, PhD
Phone
886-912170913
Email
md.hong@msa.hinet.net
First Name & Middle Initial & Last Name & Degree
Sung Jen Sung Jen, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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