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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,000
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.
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.
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
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.
Time frame: Up to 56 days after treatment
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 (%).
Time frame: 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 \[PGA scale: Clear (0) - Very Severe (5)\].
Time frame: 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.
Time frame: Up to 56 days after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
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
...and 10 more locations
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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 56 days after treatment