Psoriasis Vulgaris
Conditions
Keywords
Psoriasis Vulgaris, Jueyin granules, Blood heat syndrome, Randomized controlled trial
Brief summary
We designed this study as a multicenter, randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of psoriasis with blood stasis syndrome.
Detailed description
Psoriasis is a chronic, relapsing, inflammatory, multisystem disease characterized by infiltration of inflammatory cells, hyperplasia of epidermal keratinocytes, and abnormal differentiation. Latest data estimate that the prevalence of psoriasis in adults has increased to 11.43%, which shows that the control and treatment of psoriasis is still insufficient. Recent studies showed that traditional Chinese medicine (TCM) is one of the effective methods for the treatment of psoriasis. More and more evidences support the recognition of psoriasis not only affects the skin, but also suffers a chronic multisystem inflammation. Chinese medicine believes that the blood heat is the root of the onset of psoriasis, so the treatment of psoriasis should focus on the method of clearing heat and cooling blood. Therefore, the method of promoting clearing heat and cooling blood. has always been the focus of TCM treatment and prevention of psoriasis. This multicenter, randomized, double-blind, placebo-controlled trial will provide high-quality clinical evidences for evaluating the efficacy, safety and recurrence rate of Jueyin granule, a representative prescription for the treatment of psoriasis with blood heat syndrome, in the treatment of psoriasis.
Interventions
DRUGJueyin granules
Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
DRUGJueyin Granules Placebo
Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
Sponsors
Beijing Hospital of Traditional Chinese Medicine
First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Gansu University of Chinese Medicine
Guangxi Zhuang Autonomous Region Dermatology Hospital
Shanghai Yueyang Integrated Medicine Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes; 2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included); 3. Age between 18 and 65 years old; 4. Those who voluntarily participate in the study and sign informed consent.
Exclusion criteria
1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis; 2. Other active skin diseases may affect the condition assessment; 3. Received research drugs, biological agents and immunosuppressive agents within 1 month; 4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.; 5. During severe, uncontrollable local or systemic acute or chronic infections; 6. Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by \>1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial; 7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity; 8. Such surgery will be required during major surgery or study during 8 weeks; 9. Pregnant or lactating women; 10. A person with a history of alcohol abuse, drug abuse or drug abuse; 11. Have a history of serious mental illness or family history; 12. Other reasons researchers believe that it is inappropriate to participate in this research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis area and severity index | Up to 56 days after treatment. | Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \<10%, 2 - 10-\<30%, 3 - 30-\<50%, 4 - 50-\<70%, 5 - 70-\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment (PGA) | Up to 56 days after treatment. | 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. It 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) | Up to 56 days after treatment. | 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. |
| Body surface area (BSA) | Up to 56 days after treatment. | 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 (%) |
| Visual Analogue Score (VAS) | Up to 56 days after treatment. | 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). |
| TCM symptom score | Up to 56 days after treatment. | The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment. |
| Patient-reported quality of life (PRQoL) | Up to 56 days after treatment. | 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. |
Countries
China
Contacts
Primary ContactBin Li
Backup ContactKan Ze
Outcome results
None listed