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| Name | Class |
|---|---|
| Shanghai Dermatology Hospital | OTHER |
| Chinese Medicine Hospital Affiliated to Southwest Medical University | UNKNOWN |
| Wuhan No.1 Hospital | OTHER |
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The purpose of this study was to explore intervention time of Chinese medicine and specification of a sequential treatment plan for severe psoriasis with Chinese and Western medicine.
Psoriasis is a chronic, relapsing, inflammatory disease that seriously affects the quality of life of patients. Both Chinese medicine and Western medicine have many methods for treating psoriasis, each with its own advantages and disadvantages, but the pursuit of green and effective treatment programs is still the focus of the work of specialists and researchers. How to combine the existing safe and effective Chinese and Western medicine methods organically, and to achieve the purpose of improving efficacy under the premise of ensuring safety, is the motivation for carrying out this research.
The treatments involved in this study include cupping, phototherapy, and Chinese medicine. All three methods have sufficient literature to confirm their effectiveness in treating plaque psoriasis. The research team hopes to obtain a best combination of three treatments for plaque psoriasis by using a multicenter, randomized, single-blind, controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese medicine internal treatment group | Experimental | Participants in Chinese medicine internal treatment group will receive Jueyin granule two times daily after meals and moving cupping placebo therapy three times per week for 8 weeks. |
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| Chinese medicine external treatment group | Experimental | Participants in Chinese medicine internal treatment group will receive Jueyin placebo granule two times daily after meals and moving cupping therapy three times per week for 8 weeks. |
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| Chinese medicine treatment group | Experimental | Participants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks. |
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| Western medicine treatment group | Experimental | Participants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jueyin granules | Drug | Jueyin granules p.o. once a day for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis area and severity index | 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. | Up to 56 days after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (%) | Up to 56 days after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Li | Contact | 0086-021-55981301 | 18930568129@163.com | |
| Xiaoying Sun | Contact | 0086-021-65161782-3137 | dr_xiaoying@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Zhou | Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital Affiliated to Fujian University of TCM | Fuzhou | Fujian | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40135074 | Derived | Yu Y, Sun X, Hu R, Xia P, Wei Y, Yang W, Huang N, Ding Y, Guo S, Yang C, Weng H, Zhang Y, Ding X, Huang Q, Zhou X, Li X, Li B. A Randomized Controlled Trial for the Optimal Implementation of Psoriasis Treatment by Integrating Chinese and Western Medicine. Psoriasis (Auckl). 2025 Mar 21;15:55-66. doi: 10.2147/PTT.S487536. eCollection 2025. | |
| 32228720 |
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| The Second People's Hospital Affiliated to Fujian University of TCM |
| UNKNOWN |
| Jiangsu Province Hospital of Traditional Chinese Medicine | OTHER |
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| Integrated Chinese and Western Medicine Treatment Group | Experimental | Participants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks. |
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| moving cupping therapy | Device | Moving cupping therapy three times per week for 8 weeks. |
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| NB-UVB therapy | Device | NB-UVB phototherapy three times per week for 8 weeks. |
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| Jueyin placebo granules | Drug | Jueyin placebo granules p.o. once a day for 8 weeks. |
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| moving cupping placebo therapy | Device | Moving cupping placebo therapy three times per week for 8 weeks. |
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| NB-UVB placebo phototherapy | Device | NB-UVB placebo phototherapy three times per week for 8 weeks. |
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| 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. 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)]. | Up to 56 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. | Up to 56 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. | Up to 56 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). | Up to 56 days after treatment. |
| TCM symptom score | The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 56 days after treatment. |
| Wuhan No.1 Hospital | Wuhan | Hubei | China |
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| Jiangsu Province Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu | China |
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| Chinese Medicine Hospital Affiliated to Southwest Medical University | Luzhou | Sichuan | China |
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| Shanghai Dermatology Hospital | Shanghai | China |
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| Shanghai Yueyang Integrated Medicine Hospital | Shanghai | China |
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| Sun X, Zhou X, Wei Y, Yang W, Huang N, Ding Y, Hu R, Guo S, Yang C, Weng H, Zhang Y, Chen X, Ding X, Liu L, Yin Q, Wang R, Li X, Li B. Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine. Trials. 2020 Mar 30;21(1):299. doi: 10.1186/s13063-020-4209-3. |