Back to resultsSequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
Primary Purpose
Plaque Psoriasis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ixekizumab+Jueyin Granules
Ixekizumab+Jueyin placebo Granules
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Plaque Psoriasis, Ixekizumab, Jueyin granules, Randomized controlled trial, Traditional Chinese medicine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ixekizumab (4 weeks) + Jueyin Granules (12 weeks)
Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 (%).
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)].
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.
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.
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).
CM symptom score
The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Full Information
NCT ID
NCT05042635
First Posted
September 4, 2021
Last Updated
September 4, 2021
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Shanghai Skin Disease and Venereal Disease Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05042635
Brief Title
Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
Official Title
A Multi-center, Randomized, Double-blind Controlled Study on the Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Shanghai Skin Disease and Venereal Disease 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Plaque Psoriasis, Ixekizumab, Jueyin granules, Randomized controlled trial, Traditional Chinese medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ixekizumab (4 weeks) + Jueyin Granules (12 weeks)
Arm Type
Experimental
Arm Description
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.
Arm Title
Ixekizumab (4 weeks) + Jueyin placebo Granules(12 weeks)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab+Jueyin Granules
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ixekizumab+Jueyin placebo Granules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psoriasis area and severity index (PASI)
Description
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.
Time Frame
Up to 168 days after treatment
Secondary Outcome Measure Information:
Title
Body surface area (BSA)
Description
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 (%).
Time Frame
Up to 168 days after treatment
Title
Physician Global Assessment (PGA)
Description
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)].
Time Frame
Up to 168 days after treatment
Title
Dermatology Life quality index(DLQI)
Description
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.
Time Frame
Up to 168 days after treatment
Title
Patient-reported quality of life (PRQoL)
Description
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.
Time Frame
Up to 168 days after treatment
Title
Visual Analogue Score (VAS)
Description
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).
Time Frame
Up to 168 days after treatment
Title
CM symptom score
Description
The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Time Frame
Up to 168 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Li
Phone
0086-0021-55981301
Email
18930568129@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Li
Phone
0086-13661956326
Email
13661956326@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Li
Organizational Affiliation
Shanghai Skin Disease Hospital, School of Medicine, Tongji University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sequential Treatment of Psoriasis With Traditional Chinese and Western Medicine
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