DLQINCT05436938
To Evaluate the Mechanism of Jing Si Herbal Tea Liquid Packets and Traditional Western Medicine for Psoriasis
A study testing Jing Si herbal tea liquid packets use in people with DLQI and PHQ-9, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- What is being tested?
- Jing Si herbal tea liquid packets use
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
research ethics committee Hualien tzu chi hospital contact
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital
Hualien City, Hualien, 970
Sung Jen Sung Jen, PhD, 886-912170913, md.hong@msa.hinet.net
Sung Jen Sung Jen, PhD
About this study
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
- Being tested
- Jing Si herbal tea liquid packets use
- Keywords
- Psoriasis, Psoriatic arthritis, Comorbidities, Jing-Si-Herbal-Tea, Chinese medicine
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jing Si herbal tea liquid packets useCombination product
with or without Jing Si herbal tea liquid packets use
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis patients with mild severity, treatment group | Experimental | with Jing Si herbal tea liquid packets use Receives: Combination Product: Jing Si herbal tea liquid packets use |
| Psoriasis patients with mild severity, placebo group | Placebo comparator | without Jing Si herbal tea liquid packets use Receives: Combination Product: Jing Si herbal tea liquid packets use |
| Psoriasis patients with moderate to severe severity, treatment goup | Experimental | with Jing Si herbal tea liquid packets use Receives: Combination Product: Jing Si herbal tea liquid packets use |
| Psoriasis patients with moderate to severe severity, placebo group | Placebo comparator | without Jing Si herbal tea liquid packets use Receives: Combination Product: Jing Si herbal tea liquid packets use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)
Measured: 3 months
Secondary outcomes (3)
Dermatology Life Quality Index (DLQI)
Measured: 3 months
Patient Health Questionnaire (PHQ)-9
Measured: 3 months
serum cytokine profiles
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLQIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Jen Hung, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436938
- Sponsor's protocol ID
- TCMF-JCT 111-08
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Mechanism of Jing Si Herbal Tea Liquid Packets and Traditional Western Medicine for Psoriasis
- ClinicalTrials.gov ID
- NCT05436938
- Acronym / sponsor ID
- TCMF-JCT 111-08
- Conditions
- DLQI, PHQ-9, PSAI, Serum Cytokine Survey
- Keywords
- Psoriasis, Psoriatic arthritis, Comorbidities, Jing-Si-Herbal-Tea, Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psoriasis patients with mild severity, treatment group | Experimental | Combination Product: Jing Si herbal tea liquid packets usewith Jing Si herbal tea liquid packets use |
| Psoriasis patients with mild severity, placebo group | Placebo comparator | Combination Product: Jing Si herbal tea liquid packets usewithout Jing Si herbal tea liquid packets use |
| Psoriasis patients with moderate to severe severity, treatment goup | Experimental | Combination Product: Jing Si herbal tea liquid packets usewith Jing Si herbal tea liquid packets use |
| Psoriasis patients with moderate to severe severity, placebo group | Placebo comparator | Combination Product: Jing Si herbal tea liquid packets usewithout Jing Si herbal tea liquid packets use |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jing Si herbal tea liquid packets usewith or without Jing Si herbal tea liquid packets use | Combination product | Psoriasis patients with mild severity, placebo group, Psoriasis patients with mild severity, treatment group, Psoriasis patients with moderate to severe severity, placebo group, Psoriasis patients with moderate to severe severity, treatment goup |
Primary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: 3 months
3 secondary outcomes
Dermatology Life Quality Index (DLQI)
Time frame: 3 months
Patient Health Questionnaire (PHQ)-9
Time frame: 3 months
serum cytokine profiles
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
research ethics committee Hualien tzu chi hospital contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jing Si herbal tea liquid packets use in people with DLQI and PHQ-9, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Jen Hung, PhD (886-912170913, md.hong@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (PASI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.