Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chinese Herbal Medicine for the Treatment of Psoriasis Vulgaris: a Real World Study

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy
* Drug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy
* Drug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria of psoriatic: In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis; 18 to 65 years old, male or female patient; The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed; Informed consent must be obtained. Exclusion Criteria of psoriatic: Patients with a history of serious mental illness or family history; Other reasons that the investigator considered inappropriate to participate in the study. Inclusion Criteria of health volunteers: Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis; 18 to 65 years old, male or female patient; The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed; Informed consent must be obtained. Exclusion Criteria of health volunteers: Other active skin diseases which may affect the condition assessment are present; Those with severe, uncontrollable local or systemic acute or chronic infections; Patients with a history of serious mental illness or family history; Other reasons that the investigator considered inappropriate to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psoriasis with Blood heat syndrome group<br>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. | Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy<br>* 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.<br>|
| Experimental: Psoriasis with Blood stasis syndrome group<br>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. | Drug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy<br>* 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.<br>|
| Experimental: Psoriasis with Non-Blood heat or Blood stasis syndrome group<br>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. | Drug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy<br>* 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.<br>|
| No Intervention: Healthy control group<br>No Intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis Vulgaris, Chinese Medicine, Real World Study, Clearing heat and Cooling blood, Promoting blood circulation and Removing blood stasis