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| Name | Class |
|---|---|
| Zhejiang Provincial Hospital of TCM | OTHER |
| Shanghai Dermatology Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
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The purpose of this study is to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.
Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost.
Chinese Medicine (CM) has unique advantages in treatment of psoriasis. On the basis of CM principle--"Blood Differentiation and Treatment" in psoriasis and the combination of clinical experience, Chinese famous professor Wanzhang Qin proposed the "New Blood Syndrome Theory" in psoriasis--the psoriasis based in blood, with blood heat first, and blood stasis throughout the whole process of psoriasis. This study will form a systematic report on the diagnosis and treatment of psoriasis with the New Blood Syndrome Theory; theoretically verified by prospective cohort studies, a theoretical system of the New Blood Syndrome Theory for psoriasis will be constructed.
Objectives of this study are to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriasis with Blood heat syndrome group | Experimental | Participants in Psoriasis with Blood heat syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Clearing heat and Cooling blood, such as Cool blood detoxification Decoction I,Cool blood and activating blood prescription compound, Cool blood detoxification Decoction II, Cool blood activating blood Decoction, Tufu drink, Xiaoyin Decoction and etc., two times per day for 8 weeks. |
|
| Psoriasis with Blood stasis syndrome group | Experimental | Participants in Psoriasis with Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Promoting blood circulation and Removing blood stasis, such as Huoxue Sanyu Xiaoyin Decoction, Cool blood detoxification Decoction III and etc., two times per day for 8 weeks. |
|
| Psoriasis with Non-Blood heat or Blood stasis syndrome group | Experimental | Participants in Psoriasis with Non-Blood heat or Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of syndrome differentiation therapy two times per day for 8 weeks. |
|
| Healthy control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy | Drug | Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks. |
| 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 of psoriatic:
Exclusion Criteria of psoriatic:
Inclusion Criteria of health volunteers:
Exclusion Criteria of health volunteers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Li | Contact | 008618930568129 | 18930568129@163.com | |
| Xin Li | Contact | 008613661956326 | 13661956326@163.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 First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | Hefei | Anhui | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36189747 | Derived | Sun X, Zhao H, Wang R, Li H, Wu Y, Ze K, Su Y, Li B, Li X. Psoriasis complicated with metabolic disorder is associated with traditional Chinese medicine syndrome types: a hospital-based retrospective case-control study. Curr Med Res Opin. 2023 Jan;39(1):19-25. doi: 10.1080/03007995.2022.2129803. Epub 2022 Oct 11. | |
| 31930095 | Derived |
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| Changhai Hospital |
| OTHER |
| Shanghai 10th People's Hospital | OTHER |
| Beijing Hospital of Traditional Chinese Medicine | OTHER |
| Wuhan No.1 Hospital | OTHER |
| Jiangsu Province Hospital of Traditional Chinese Medicine | OTHER |
| Chinese Medicine Hospital Affiliated to Southwest Medical University | UNKNOWN |
| First Affiliated Hospital of Heilongjiang Chinese Medicine University | OTHER |
| The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine | OTHER |
| The Second Affiliated Hospital of Jiangxi University of TCM | UNKNOWN |
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
| The Guangxi Zhuang Autonomous Region Institute of Dermatology and control | UNKNOWN |
| The First Affiliated Hospital of Guiyang College of TCM | UNKNOWN |
| The Second People's Hospital Affiliated to Fujian University of TCM | UNKNOWN |
| Gansu University of Chinese Medicine | OTHER |
| Shanxi Provincial Hospital of Traditional Chinese Medicine | UNKNOWN |
| Shijiazhuang Hospital of Traditional Chinese Medicine | UNKNOWN |
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No Intervention.
| Oral Chinese Herbal Medicine according with syndrome differentiation therapy | Drug | Oral Chinese Herbal Medicine according with syndrome differentiation therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks. |
|
| Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy | Drug | Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks. |
|
| 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 |
| CM symptom score | The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment. | Up to 56 days after treatment |
| Beijing Hospital of Traditional Chinese Medicine |
| Beijing |
| Beijing Municipality |
| China |
| The Second People's Hospital Affiliated to Fujian University of TCM | Fuzhou | Fujian | China |
| Affiliated Hospital of Gansu University of traditional Chinese Medicine | Lanzhou | Gansu | China |
| The Guangxi Zhuang Autonomous Region Institute of Dermatology and control | Nanning | Guangxi | China |
| The First Affiliated Hospital of Guiyang College of TCM | Guiyang | Guizhou | China |
| Shijiazhuang Hospital of Traditional Chinese Medicine | Shijiazhuang | Hebei | China |
| First Affiliated Hospital of Heilongjiang Chinese Medicine University | Harbin | Heilongjiang | China |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou | Henan | China |
| Wuhan No.1 Hospital | Wuhan | Hubei | China |
| Jiangsu Province Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu | China |
| Affiliated hospital of jiangxi university of traditional Chinese medicine | Nanchang | Jiangxi | China |
| The Second Affiliated Hospital of Jiangxi University of TCM | Nanchang | Jiangxi | China |
| Changhai Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai 10th People's Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Yueyang Integrated Medicine Hospital | Shanghai | Shanghai Municipality | China |
| Shanxi Provincial Hospital of Traditional Chinese Medicine | Xi’an | Shanxi | China |
| Chinese Medicine Hospital Affiliated to Southwest Medical University | Luzhou | Sichuan | China |
| Zhejiang Provincial Hospital of TCM | Hangzhou | Zhejiang | China |
| Luo Y, Ru Y, Sun X, Zhou Y, Yang Y, Ma T, Xu R, Chen J, Zhou M, Ze K, Ju L, Wang Y, Yin Q, Wang R, Li B, Li X. Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol. Ann Transl Med. 2019 Nov;7(22):694. doi: 10.21037/atm.2019.10.46. |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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