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

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.

Study Overview

• Status: Unknown
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Jueyin granules; Device: moving cupping placebo therapy; Device: moving cupping therapy; Drug: Jueyin placebo granules; Device: NB-UVB placebo phototherapy; Device: NB-UVB therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 378
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaoying Sun; Phone Number: 0086-021-65161782-3137; Email: dr_xiaoying@126.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Dermatology Hospital
    • Contact: Yangfeng Ding
  • Shanghai, China
    • Shanghai Yueyang Integrated Medicine Hospital
    • Contact: Bin Li
  • Fujian
    • Fuzhou, Fujian, China
      • The Second People's Hospital Affiliated to Fujian University of TCM
      • Contact: Ning Huang
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan No.1 hospital
      • Contact: Xiaoyong Zhou
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital of Traditional Chinese Medicine
      • Contact: Yuegang Wei
  • Sichuan
    • Luzhou, Sichuan, China
      • Chinese Medicine Hospital Affiliated to Southwest Medical University
      • Contact: Wenxin Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese medicine internal treatment group; Participants 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.	Drug: Jueyin granules; Jueyin granules p.o. once a day for 8 weeks.; Other Names: Chinese Herbal Medicine; Device: moving cupping placebo therapy; Moving cupping placebo therapy three times per week for 8 weeks.
Experimental: Chinese medicine external treatment group; Participants 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.	Device: moving cupping therapy; Moving cupping therapy three times per week for 8 weeks.; Drug: Jueyin placebo granules; Jueyin placebo granules p.o. once a day for 8 weeks.; Other Names: Chinese Herbal Medicine
Experimental: Chinese medicine treatment group; Participants 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.	Drug: Jueyin granules; Jueyin granules p.o. once a day for 8 weeks.; Other Names: Chinese Herbal Medicine; Device: moving cupping therapy; Moving cupping therapy three times per week for 8 weeks.; Device: NB-UVB placebo phototherapy; NB-UVB placebo phototherapy three times per week for 8 weeks.
Experimental: Western medicine treatment group; Participants 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.	Device: moving cupping placebo therapy; Moving cupping placebo therapy three times per week for 8 weeks.; Drug: Jueyin placebo granules; Jueyin placebo granules p.o. once a day for 8 weeks.; Other Names: Chinese Herbal Medicine; Device: NB-UVB therapy; NB-UVB phototherapy three times per week for 8 weeks.
Experimental: Integrated Chinese and Western Medicine Treatment Group; Participants 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.	Drug: Jueyin granules; Jueyin granules p.o. once a day for 8 weeks.; Other Names: Chinese Herbal Medicine; Device: moving cupping therapy; Moving cupping therapy three times per week for 8 weeks.; Device: NB-UVB therapy; NB-UVB phototherapy three times per week for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body surface area (BSA)	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 (%)	Up to 56 days after treatment.
Physician Global Assessment (PGA)	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)].	Up to 56 days after treatment.
Dermatology Life quality index(DLQI)	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.	Up to 56 days after treatment.
Patient-reported quality of life (PRQoL)	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.	Up to 56 days after treatment.
Visual Analogue Score (VAS)	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).	Up to 56 days after treatment.
TCM symptom score	The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.	Up to 56 days after treatment.

Collaborators and Investigators

• Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine; Wuhan No.1 Hospital; Shanghai Dermatology Hospital; Chinese Medicine Hospital Affiliated to Southwest Medical University; The Second People's Hospital Affiliated to Fujian University of TCM

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Plaque Psoriasis; Moving cupping; Jueyin granule; NB-UVB; combination of Chinese traditional and Western medicine
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 2018YFC1705304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No