Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine

Shanghai Yueyang Integrated Medicine Hospital

Status and phase: Unknown; Phase 2

Conditions: Plaque Psoriasis

Treatments: Device: NB-UVB therapy; Drug: Jueyin granules; Device: moving cupping placebo therapy; Drug: Jueyin placebo granules; Device: NB-UVB placebo phototherapy; Device: moving cupping therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03941431

2018YFC1705304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 378 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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378 participants in 5 patient groups

Chinese medicine internal treatment group

Experimental group

Description:

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.

Treatment:

Device: moving cupping placebo therapy

Drug: Jueyin granules

Chinese medicine external treatment group

Experimental group

Description:

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.

Treatment:

Device: moving cupping therapy

Drug: Jueyin placebo granules

Chinese medicine treatment group

Experimental group

Description:

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.

Treatment:

Device: NB-UVB placebo phototherapy

Device: moving cupping therapy

Drug: Jueyin granules

Western medicine treatment group

Experimental group

Description:

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.

Treatment:

Device: NB-UVB therapy

Device: moving cupping placebo therapy

Drug: Jueyin placebo granules

Integrated Chinese and Western Medicine Treatment Group

Experimental group

Description:

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.

Treatment:

Device: moving cupping therapy

Device: NB-UVB therapy

Drug: Jueyin granules