Clinical trial NCT03941431: Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine
Official title: Optimally Sequential Treatment of Integrated Chinese and Western Medicine for Psoriasis: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Jueyin granule
Moving cupping
NB-UVB
combination of Chinese traditional and Western medicine
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Dermatology Hospital
name: Chinese Medicine Hospital Affiliated to Southwest Medical University
name: Wuhan No.1 Hospital
name: The Second People's Hospital Affiliated to Fujian University of TCM
name: Jiangsu Province Hospital of Traditional Chinese Medicine
First posted: 2019-05-08
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to explore intervention time of Chinese medicine and specification of a sequential treatment plan for severe psoriasis with Chinese and Western medicine.

Detailed description: Psoriasis is a chronic, relapsing, inflammatory disease that seriously affects the quality of life of patients. Both Chinese medicine and Western medicine have many methods for treating psoriasis, each with its own advantages and disadvantages, but the pursuit of green and effective treatment programs is still the focus of the work of specialists and researchers. How to combine the existing safe and effective Chinese and Western medicine methods organically, and to achieve the purpose of improving efficacy under the premise of ensuring safety, is the motivation for carrying out this research.

The treatments involved in this study include cupping, phototherapy, and Chinese medicine. All three methods have sufficient literature to confirm their effectiveness in treating plaque psoriasis. The research team hopes to obtain a best combination of three treatments for plaque psoriasis by using a multicenter, randomized, single-blind, controlled trial.

Eligibility criteria: Inclusion Criteria:

1. Plaque psoriasis, the course of disease is not limited.
2. Skin lesions involving ≤ 15% BSA (the lesions are mainly located in the trunk and / or limbs, palm / sole, face / scalp, vulva area is not included).
3. 18 to 65 years old, male or female patient.
4. Informed consent must be obtained.

Exclusion Criteria:

1. other active skin diseases which may affect the condition assessment are present.
2. Patients who received systematic treatment of research drugs, biological agents and immunosuppressive agents within 2 months.
3. Patients who received treatment with topical glucocorticoids, phototherapy, etc. within 2 weeks.
4. Those with severe, uncontrollable local or systemic acute or chronic infections.
5. patients with severe systemic diseases; or clinical test indicators in one of the following cases: alanine transferase or glutamate transferase increased by \>1.5 times the upper limit of normal; serum creatinine increased by \>1.5 times the upper limit of normal Any of the main blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) below the lower limit of normal; or other laboratory abnormalities judged by the investigator are not suitable for participation in this trial.
6. Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity.
7. Patients underwent major surgery within 8 weeks or will require such surgery during the study period.
8. Patients who are pregnant or in lactation.
9. Those have a history of alcohol abuse, drug abuse or drug abuse.
10. Patients with a history of serious mental illness or family history.
11. Patients with a family history of cancer.
12. 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: TCM symptom score
timeFrame: Up to 56 days after treatment.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The Second People's Hospital Affiliated to Fujian University of TCM
state: Fujian
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: Luzhou
country: China
facility: Chinese Medicine Hospital Affiliated to Southwest Medical University
state: Sichuan
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
Study officials:
affiliation: Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
name: Jia Zhou
role: STUDY_CHAIR
References:
citation: Sun X, Zhou X, Wei Y, Yang W, Huang N, Ding Y, Hu R, Guo S, Yang C, Weng H, Zhang Y, Chen X, Ding X, Liu L, Yin Q, Wang R, Li X, Li B. Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine. Trials. 2020 Mar 30;21(1):299. doi: 10.1186/s13063-020-4209-3.