Psoriasis
Conditions
Keywords
Psoriasis Vulgaris, Chinese Medicine, Real World Study, Clearing heat and Cooling blood, Promoting blood circulation and Removing blood stasis
Brief summary
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
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.
Interventions
DRUGOral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy
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.
DRUGOral Chinese Herbal Medicine according with syndrome differentiation therapy
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.
DRUGOral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
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.
Sponsors
Zhejiang Provincial Hospital of TCM
Shanghai Dermatology Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Changhai Hospital
Shanghai 10th People's Hospital
Beijing Hospital of Traditional Chinese Medicine
Wuhan No.1 Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Chinese Medicine Hospital Affiliated to Southwest Medical University
First Affiliated Hospital of Heilongjiang Chinese Medicine University
The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
The Second Affiliated Hospital of Jiangxi University of TCM
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
The First Affiliated Hospital of Guiyang College of TCM
The Second People's Hospital Affiliated to Fujian University of TCM
Gansu University of Chinese Medicine
Shanxi Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang Hospital of Traditional Chinese Medicine
Shanghai Yueyang Integrated Medicine Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
of psoriatic: 1. In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis; 2. 18 to 65 years old, male or female patient; 3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed; 4. Informed consent must be obtained.
Exclusion criteria
of psoriatic: 1. Patients with a history of serious mental illness or family history; 2. Other reasons that the investigator considered inappropriate to participate in the study. Inclusion Criteria of health volunteers: 1. Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis; 2. 18 to 65 years old, male or female patient; 3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed; 4. Informed consent must be obtained.
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). |
| CM symptom score | Up to 56 days after treatment | The CM 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 ContactXin Li
Outcome results
None listed