Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine
Optimally Sequential Treatment of Integrated Chinese and Western Medicine for Psoriasis: a Multicenter Randomized Controlled Trial
1 other identifier
interventional
378
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2019
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 8, 2019
May 1, 2019
2.6 years
May 1, 2019
May 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 56 days after treatment.
Secondary Outcomes (6)
Body surface area (BSA)
Up to 56 days after treatment.
Physician Global Assessment (PGA)
Up to 56 days after treatment.
Dermatology Life quality index(DLQI)
Up to 56 days after treatment.
Patient-reported quality of life (PRQoL)
Up to 56 days after treatment.
Visual Analogue Score (VAS)
Up to 56 days after treatment.
- +1 more secondary outcomes
Study Arms (5)
Chinese medicine internal treatment group
EXPERIMENTALParticipants in Chinese medicine internal treatment group will receive Jueyin granule two times daily after meals and moving cupping placebo therapy three times per week for 8 weeks.
Chinese medicine external treatment group
EXPERIMENTALParticipants in Chinese medicine internal treatment group will receive Jueyin placebo granule two times daily after meals and moving cupping therapy three times per week for 8 weeks.
Chinese medicine treatment group
EXPERIMENTALParticipants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks.
Western medicine treatment group
EXPERIMENTALParticipants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks.
Integrated Chinese and Western Medicine Treatment Group
EXPERIMENTALParticipants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks.
Interventions
Jueyin granules p.o. once a day for 8 weeks.
Moving cupping therapy three times per week for 8 weeks.
NB-UVB phototherapy three times per week for 8 weeks.
Jueyin placebo granules p.o. once a day for 8 weeks.
Moving cupping placebo therapy three times per week for 8 weeks.
NB-UVB placebo phototherapy three times per week for 8 weeks.
Eligibility Criteria
You may qualify if:
- Plaque psoriasis, the course of disease is not limited.
- 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).
- to 65 years old, male or female patient.
- Informed consent must be obtained.
You may not qualify if:
- other active skin diseases which may affect the condition assessment are present.
- Patients who received systematic treatment of research drugs, biological agents and immunosuppressive agents within 2 months.
- Patients who received treatment with topical glucocorticoids, phototherapy, etc. within 2 weeks.
- Those with severe, uncontrollable local or systemic acute or chronic infections.
- 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.
- Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity.
- Patients underwent major surgery within 8 weeks or will require such surgery during the study period.
- Patients who are pregnant or in lactation.
- Those have a history of alcohol abuse, drug abuse or drug abuse.
- Patients with a history of serious mental illness or family history.
- Patients with a family history of cancer.
- Other reasons that the investigator considered inappropriate to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Yueyang Integrated Medicine Hospitallead
- Shanghai Dermatology Hospitalcollaborator
- Chinese Medicine Hospital Affiliated to Southwest Medical Universitycollaborator
- Wuhan No.1 Hospitalcollaborator
- The Second People's Hospital Affiliated to Fujian University of TCMcollaborator
- Jiangsu Province Hospital of Traditional Chinese Medicinecollaborator
Study Sites (6)
The Second People's Hospital Affiliated to Fujian University of TCM
Fuzhou, Fujian, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Chinese Medicine Hospital Affiliated to Southwest Medical University
Luzhou, Sichuan, China
Shanghai Dermatology Hospital
Shanghai, China
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, China
Related Publications (2)
Yu Y, Sun X, Hu R, Xia P, Wei Y, Yang W, Huang N, Ding Y, Guo S, Yang C, Weng H, Zhang Y, Ding X, Huang Q, Zhou X, Li X, Li B. A Randomized Controlled Trial for the Optimal Implementation of Psoriasis Treatment by Integrating Chinese and Western Medicine. Psoriasis (Auckl). 2025 Mar 21;15:55-66. doi: 10.2147/PTT.S487536. eCollection 2025.
PMID: 40135074DERIVEDSun 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.
PMID: 32228720DERIVED
Study Officials
- STUDY CHAIR
Jia Zhou
Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2019
First Posted
May 8, 2019
Study Start
June 1, 2019
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
May 8, 2019
Record last verified: 2019-05