Clinical trial NCT03942185: Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study
Official title: Chinese Herbal Medicine for the Treatment of Psoriasis Vulgaris: a Real World Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis Vulgaris
Chinese Medicine
Real World Study
Clearing heat and Cooling blood
Promoting blood circulation and Removing blood stasis
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Hospital of TCM
name: Shanghai Dermatology Hospital
name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Changhai Hospital
name: Shanghai 10th People's Hospital
name: Beijing Hospital of Traditional Chinese Medicine
name: Wuhan No.1 Hospital
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Chinese Medicine Hospital Affiliated to Southwest Medical University
name: First Affiliated Hospital of Heilongjiang Chinese Medicine University
name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
name: The Second Affiliated Hospital of Jiangxi University of TCM
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
name: The First Affiliated Hospital of Guiyang College of TCM
name: The Second People's Hospital Affiliated to Fujian University of TCM
name: Gansu University of Chinese Medicine
name: Shanxi Provincial Hospital of Traditional Chinese Medicine
name: Shijiazhuang Hospital of Traditional Chinese Medicine
First posted: 2019-05-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Exclusion Criteria of health volunteers:

1. Other active skin diseases which may affect the condition assessment are present;
2. Those with severe, uncontrollable local or systemic acute or chronic infections;
3. Patients with a history of serious mental illness or family history;
4. Other reasons that the investigator considered inappropriate to participate in the study.

Primary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: Up to 56 days after treatment
Secondary outcomes:
measure: Body surface area (BSA)
timeFrame: Up to 56 days after treatment
measure: Physician Global Assessment (PGA)
timeFrame: Up to 56 days after treatment
measure: Dermatology Life quality index(DLQI)
timeFrame: Up to 56 days after treatment
measure: Patient-reported quality of life (PRQoL)
timeFrame: Up to 56 days after treatment
measure: Visual Analogue Score (VAS)
timeFrame: Up to 56 days after treatment
measure: CM symptom score
timeFrame: Up to 56 days after treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
state: Anhui
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
state: Beijing
city: Fuzhou
country: China
facility: The Second People's Hospital Affiliated to Fujian University of TCM
state: Fujian
city: Lanzhou
country: China
facility: Affiliated Hospital of Gansu University of traditional Chinese Medicine
state: Gansu
city: Nanning
country: China
facility: The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
state: Guangxi
city: Guiyang
country: China
facility: The First Affiliated Hospital of Guiyang College of TCM
state: Guizhou
city: Shijiazhuang
country: China
facility: Shijiazhuang Hospital of Traditional Chinese Medicine
state: Hebei
city: Ha'erbin
country: China
facility: First Affiliated Hospital of Heilongjiang Chinese Medicine University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
city: Wuhan
country: China
facility: Wuhan No.1 Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanchang
country: China
facility: Affiliated hospital of jiangxi university of traditional Chinese medicine
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Jiangxi University of TCM
state: Jiangxi
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
state: Shanghai
city: Xi'an
country: China
facility: Shanxi Provincial Hospital of Traditional Chinese Medicine
state: Shanxi
city: Luzhou
country: China
facility: Chinese Medicine Hospital Affiliated to Southwest Medical University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of TCM
state: Zhejiang
Study officials:
affiliation: Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
name: Jia Zhou
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.