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Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine

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ClinicalTrials.gov Identifier: NCT03941431
Recruitment Status : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborators:
Shanghai Dermatology Hospital
Chinese Medicine Hospital Affiliated to Southwest Medical University
Wuhan No.1 Hospital
The Second People's Hospital Affiliated to Fujian University of TCM
Jiangsu Province Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Jueyin granules Device: moving cupping therapy Device: NB-UVB therapy Drug: Jueyin placebo granules Device: moving cupping placebo therapy Device: NB-UVB placebo phototherapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimally Sequential Treatment of Integrated Chinese and Western Medicine for Psoriasis: a Multicenter Randomized Controlled Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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 Name: 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 Name: 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 Name: 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: NB-UVB therapy
NB-UVB phototherapy three times per week for 8 weeks.

Drug: Jueyin placebo granules
Jueyin placebo granules p.o. once a day for 8 weeks.
Other Name: Chinese Herbal Medicine

Device: moving cupping placebo therapy
Moving cupping placebo therapy 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 Name: 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.




Primary Outcome Measures :
  1. Psoriasis area and severity index [ Time Frame: 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 :
  1. Body surface area (BSA) [ Time Frame: 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 (%)

  2. Physician Global Assessment (PGA) [ Time Frame: 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)].

  3. Dermatology Life quality index(DLQI) [ Time Frame: 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.

  4. Patient-reported quality of life (PRQoL) [ Time Frame: 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.

  5. Visual Analogue Score (VAS) [ Time Frame: 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).

  6. TCM symptom score [ Time Frame: Up to 56 days after treatment. ]
    The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941431


Contacts
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Contact: Bin Li 0086-021-55981301 18930568129@163.com
Contact: Xiaoying Sun 0086-021-65161782-3137 dr_xiaoying@126.com

Locations
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China, Fujian
The Second People's Hospital Affiliated to Fujian University of TCM Not yet recruiting
Fuzhou, Fujian, China
Contact: Ning Huang         
China, Hubei
Wuhan No.1 Hospital Not yet recruiting
Wuhan, Hubei, China
Contact: Xiaoyong Zhou         
China, Jiangsu
Jiangsu Province Hospital of Traditional Chinese Medicine Not yet recruiting
Nanjing, Jiangsu, China
Contact: Yuegang Wei         
China, Sichuan
Chinese Medicine Hospital Affiliated to Southwest Medical University Not yet recruiting
Luzhou, Sichuan, China
Contact: Wenxin Yang         
China
Shanghai Dermatology Hospital Not yet recruiting
Shanghai, China
Contact: Yangfeng Ding         
Shanghai Yueyang Integrated Medicine Hospital Not yet recruiting
Shanghai, China
Contact: Bin Li         
Sponsors and Collaborators
Shanghai Yueyang Integrated Medicine Hospital
Shanghai Dermatology Hospital
Chinese Medicine Hospital Affiliated to Southwest Medical University
Wuhan No.1 Hospital
The Second People's Hospital Affiliated to Fujian University of TCM
Jiangsu Province Hospital of Traditional Chinese Medicine
Investigators
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Study Chair: Jia Zhou Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai

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Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
ClinicalTrials.gov Identifier: NCT03941431     History of Changes
Other Study ID Numbers: 2018YFC1705304
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:
Plaque Psoriasis
Jueyin granule
Moving cupping
NB-UVB
combination of Chinese traditional and Western medicine
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases