Plaque PsoriasisNCT05042635
Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
A study testing Ixekizumab+Jueyin Granules in people with Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial summary
The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Ixekizumab+Jueyin Granules
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Sep 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- It conforms to the western diagnostic criteria of plaque psoriasis and the diagnostic criteria of TCM syndrome of blood heat syndrome;
- Physician global assessment (PGA) ≥3, psoriasis area and severity index (PASI) score ≥12, and body surface area (BSA) ≥ 10% at screening and baseline;
- Aged between 18 and 70;
- Those who voluntarily participate in the study and sign the informed consent.
Who cannot join
- Erythrodermic psoriasis patients, arthropathic psoriasis patients, pustular psoriasis patients;
- There are other active skin diseases that may affect the evaluator;
- Have systematically received other investigational drugs within 1 month;
- Received external glucocorticoid and phototherapy within 2 weeks;
- During a period of severe and uncontrollable local or systemic acute or chronic infection;
- Infected persons with tuberculosis;
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- Patients with viral hepatitis;
- Serious systemic disease; Or clinical test indicators belong to one of the following cases of patients: alanine aminotransferase or glutamic-oxalacetic transaminase increase > 1.5 times the upper limit of normal value; Creatinine increase > 1.5 times the upper limit of normal value; Any one of the major blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) is lower than the lower limit of normal value; Or other abnormal laboratory tests determined by the investigator to be unsuitable for the study;
- Patients with a history of malignant tumor and patients with primary or secondary immune deficiency and hypersensitivity;
- Participants in clinical trials of other drugs within 3 months;
- Those who have undergone major surgery within 8 weeks or will require such surgery during the study period;
- For fertile women of childbearing age who did not use highly effective contraception from the screening period until the end of the last dose;
- Pregnant or lactating women;
- Persons with a history of alcohol, drug or substance abuse;
- Persons with a serious history of mental illness or family history;
- For other reasons, the researcher considers it inappropriate to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Randomized, Double-blind Controlled Study on the Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.
Read the detailed description
Psoriasis is a chronic, recurrent, inflammatory disease. The incidence of this disease is increasing year by year, seriously affecting people's quality of life. Biologic agents have the advantages of rapid and efficient treatment of moderate and severe psoriasis, but their safety and recurrence are still seriously affect the application. Traditional Chinese medicine treatment of psoriasis has the advantages of fewer adverse reactions, low recurrence rate and improvement of patients' systemic symptoms while exerting the curative effect. The prevention and treatment of psoriasis by combining traditional Chinese and Western medicine has become the academic consensus. The sequential treatment of psoriasis with biological agents combined with Traditional Chinese medicine has a better therapeutic effect than that of single therapy. At present, the sequential treatment of psoriasis with targeted biological agents combined with traditional Chinese medicine has not been reported in the literature, and there is a lack of high-level clinical evidence to support it. Therefore, this project aims to provide evidence support for the clinical efficacy and safety of sequential treatment of psoriasis by traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.
- Conditions
- Plaque Psoriasis
- Being tested
- Ixekizumab+Jueyin Granules, Ixekizumab+Jueyin placebo Granules
- Keywords
- Plaque Psoriasis, Ixekizumab, Jueyin granules, Randomized controlled trial, Traditional Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ixekizumab+Jueyin GranulesDrug
Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once).
Jueyin Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.
Ixekizumab+Jueyin placebo GranulesDrug
Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once).
Jueyin placebo Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times.
| Study group | Role | What they receive |
|---|---|---|
| Ixekizumab (4 weeks) + Jueyin Granules (12 weeks) | Experimental | Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin Granules was used in the 12-week traditional Chinese medicine treatment period. Receives: Drug: Ixekizumab+Jueyin Granules |
| Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks) | Placebo comparator | Subjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin placebo Granules was used in the 12-week traditional Chinese medicine treatment period. Receives: Drug: Ixekizumab+Jueyin placebo Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis area and severity index (PASI)
Psoriasis area and severity index (PASI) score and recurrence assessment. Psoriasis area and severity index (PASI) scores were assessed for all patients at each follow-up. Recurrence was defined as a 50% reduction in maximum PASI improvement from baseline at week 40.
Measured: Up to 168 days after treatment
Secondary outcomes (6)
Body surface area (BSA)
The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%).
Measured: Up to 168 days after treatment
Physician Global Assessment (PGA)
Physician Global Assessment (PGA)is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I),desquamation (D) across all psoriatic lesions. lt is calculated as follows: PGA score = (E +I+D) / 3 then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0)-Very Severe (5)].
Measured: Up to 168 days after treatment
Dermatology Life quality index(DLQI)
The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life.
Measured: Up to 168 days after treatment
Patient-reported quality of life (PRQoL)
PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life.
Measured: Up to 168 days after treatment
Visual Analogue Score (VAS)
Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis).
Measured: Up to 168 days after treatment
CM symptom score
The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Measured: Up to 168 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Skin Disease and Venereal Disease Hospital
- Responsible party
- Sponsor
- Investigators
- Bin Li, Study chair, Shanghai Skin Disease Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042635
- Sponsor's protocol ID
- 21Y21920100
- Status last verified
- Sep 2021
- First submitted
- 4 Sep 2021
- Last updated
- 13 Sep 2021
- 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 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind Controlled Study on the Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT05042635
- Acronym / sponsor ID
- 21Y21920100
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque Psoriasis, Ixekizumab, Jueyin granules, Randomized controlled trial, Traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Collaborators
- Shanghai Skin Disease and Venereal Disease Hospital
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 13 Sep 2021 (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.
The purpose of this study is to objectively and standardly evaluate the clinical efficacy and safety of sequential treatment of psoriasis with traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.
Detailed description
Psoriasis is a chronic, recurrent, inflammatory disease. The incidence of this disease is increasing year by year, seriously affecting people's quality of life. Biologic agents have the advantages of rapid and efficient treatment of moderate and severe psoriasis, but their safety and recurrence are still seriously affect the application. Traditional Chinese medicine treatment of psoriasis has the advantages of fewer adverse reactions, low recurrence rate and improvement of patients' systemic symptoms while exerting the curative effect. The prevention and treatment of psoriasis by combining traditional Chinese and Western medicine has become the academic consensus. The sequential treatment of psoriasis with biological agents combined with Traditional Chinese medicine has a better therapeutic effect than that of single therapy. At present, the sequential treatment of psoriasis with targeted biological agents combined with traditional Chinese medicine has not been reported in the literature, and there is a lack of high-level clinical evidence to support it. Therefore, this project aims to provide evidence support for the clinical efficacy and safety of sequential treatment of psoriasis by traditional Chinese and Western medicine through a multi-center, randomized, double-blind, placebo-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ixekizumab (4 weeks) + Jueyin Granules (12 weeks) | Experimental | Drug: Ixekizumab+Jueyin GranulesSubjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin Granules was used in the 12-week traditional Chinese medicine treatment period. |
| Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks) | Placebo comparator | Drug: Ixekizumab+Jueyin placebo GranulesSubjects received Ixekizumab in the first 4 weeks (biologic treatment period); After the cessation of biologic treatment, only Jueyin placebo Granules was used in the 12-week traditional Chinese medicine treatment period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- It conforms to the western diagnostic criteria of plaque psoriasis and the diagnostic criteria of TCM syndrome of blood heat syndrome;
- Physician global assessment (PGA) ≥3, psoriasis area and severity index (PASI) score ≥12, and body surface area (BSA) ≥ 10% at screening and baseline;
- Aged between 18 and 70;
- Those who voluntarily participate in the study and sign the informed consent.
Key exclusion criteria (16 listed)
- Erythrodermic psoriasis patients, arthropathic psoriasis patients, pustular psoriasis patients;
- There are other active skin diseases that may affect the evaluator;
- Have systematically received other investigational drugs within 1 month;
- Received external glucocorticoid and phototherapy within 2 weeks;
- During a period of severe and uncontrollable local or systemic acute or chronic infection;
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 |
|---|---|---|
| Ixekizumab+Jueyin GranulesIxekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times. | Drug | Ixekizumab (4 weeks) + Jueyin Granules (12 weeks) |
| Ixekizumab+Jueyin placebo GranulesIxekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once). Jueyin placebo Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times. | Drug | Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks) |
Primary outcome
Psoriasis area and severity index (PASI)
Time frame: Up to 168 days after treatment
Psoriasis area and severity index (PASI) score and recurrence assessment. Psoriasis area and severity index (PASI) scores were assessed for all patients at each follow-up. Recurrence was defined as a 50% reduction in maximum PASI improvement from baseline at week 40.
6 secondary outcomes
Body surface area (BSA)
Time frame: Up to 168 days after treatment
Physician Global Assessment (PGA)
Time frame: Up to 168 days after treatment
Dermatology Life quality index(DLQI)
Time frame: Up to 168 days after treatment
Patient-reported quality of life (PRQoL)
Time frame: Up to 168 days after treatment
Visual Analogue Score (VAS)
Time frame: Up to 168 days after treatment
CM symptom score
Time frame: Up to 168 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- 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.
Bin Li study chair
Shanghai Skin Disease Hospital, School of Medicine, Tongji University
Questions about this trial
What is this clinical trial studying?
A study testing Ixekizumab+Jueyin Granules in people with Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital.
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 4 inclusion and 16 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Bin Li (0086-0021-55981301, 18930568129@163.com), 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: Up to 168 days after treatment). 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 13 Sep 2021.