Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03941431
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Yueyang Integrated Medicine Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jia Zhou
Principal Investigator Affiliation Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherOtherOtherOther
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

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.

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.

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.

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.

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.

Interventions

Drug: - Jueyin granules

Jueyin granules p.o. once a day for 8 weeks.

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.

Drug: - Jueyin placebo granules

Jueyin placebo granules p.o. once a day for 8 weeks.

Device: - moving cupping placebo therapy

Moving cupping placebo therapy three times per week for 8 weeks.

Device: - NB-UVB placebo phototherapy

NB-UVB placebo phototherapy three times per week for 8 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fuzhou, Fujian, China

Status

Address

The Second People's Hospital Affiliated to Fujian University of TCM

Fuzhou, Fujian,

Site Contact

Ning Huang

[email protected]

0086-021-55981301

Wuhan No.1 Hospital, Wuhan, Hubei, China

Status

Address

Wuhan No.1 Hospital

Wuhan, Hubei,

Site Contact

Xiaoyong Zhou

[email protected]

0086-021-55981301

Nanjing, Jiangsu, China

Status

Address

Jiangsu Province Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu,

Site Contact

Yuegang Wei

[email protected]

0086-021-55981301

Luzhou, Sichuan, China

Status

Address

Chinese Medicine Hospital Affiliated to Southwest Medical University

Luzhou, Sichuan,

Site Contact

Wenxin Yang

[email protected]

0086-021-55981301

Shanghai Dermatology Hospital, Shanghai, China

Status

Address

Shanghai Dermatology Hospital

Shanghai, ,

Site Contact

Yangfeng Ding

[email protected]

0086-021-55981301

Shanghai, China

Status

Address

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, ,

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