Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study
- Conditions
- Psoriasis
- Interventions
- Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapyDrug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapyDrug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy
- Registration Number
- NCT03942185
- Lead Sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psoriasis with Blood heat syndrome group Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy 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 Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy 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 Oral Chinese Herbal Medicine according with syndrome differentiation therapy 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 (%).
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.
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.
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.
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).
Trial Locations
- Locations (20)
Affiliated Hospital of Gansu University of traditional Chinese Medicine
🇨🇳Lanzhou, Gansu, 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
Shanghai 10th People's Hospital
🇨🇳Shanghai, Shanghai, China
Zhejiang Provincial Hospital of TCM
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
🇨🇳Hefei, Anhui, China
First Affiliated Hospital of Heilongjiang Chinese Medicine University
🇨🇳Ha'erbin, Heilongjiang, China
Shanxi Provincial Hospital of Traditional Chinese Medicine
🇨🇳Xi'an, Shanxi, China
The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
🇨🇳Zhengzhou, Henan, China
Changhai Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Dermatology Hospital
🇨🇳Shanghai, Shanghai, China
Chinese Medicine Hospital Affiliated to Southwest Medical University
🇨🇳Luzhou, Sichuan, China
The Second People's Hospital Affiliated to Fujian University of TCM
🇨🇳Fuzhou, Fujian, China
Beijing Hospital of Traditional Chinese Medicine
🇨🇳Beijing, Beijing, China
Shijiazhuang Hospital of Traditional Chinese Medicine
🇨🇳Shijiazhuang, Hebei, China
The First Affiliated Hospital of Guiyang College of TCM
🇨🇳Guiyang, Guizhou, China
Jiangsu Province Hospital of Traditional Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
Wuhan No.1 Hospital
🇨🇳Wuhan, Hubei, China
Shanghai Yueyang Integrated Medicine Hospital
🇨🇳Shanghai, Shanghai, China