Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study

Shanghai Yueyang Integrated Medicine Hospital

Status and phase: Unknown; Phase 2

Conditions: Psoriasis

Treatments: Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy; Drug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy; Drug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03942185

2018YFC1705301

Details and patient eligibility

About

The purpose of this study is to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.

Full description

Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost.

Chinese Medicine (CM) has unique advantages in treatment of psoriasis. On the basis of CM principle--"Blood Differentiation and Treatment" in psoriasis and the combination of clinical experience, Chinese famous professor Wanzhang Qin proposed the "New Blood Syndrome Theory" in psoriasis--the psoriasis based in blood, with blood heat first, and blood stasis throughout the whole process of psoriasis. This study will form a systematic report on the diagnosis and treatment of psoriasis with the New Blood Syndrome Theory; theoretically verified by prospective cohort studies, a theoretical system of the New Blood Syndrome Theory for psoriasis will be constructed.

Objectives of this study are to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria of psoriatic:

1. In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
2. 18 to 65 years old, male or female patient;
3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
4. Informed consent must be obtained.

Exclusion Criteria of psoriatic:

1. Patients with a history of serious mental illness or family history;
2. Other reasons that the investigator considered inappropriate to participate in the study.

Inclusion Criteria of health volunteers:

1. Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
2. 18 to 65 years old, male or female patient;
3. The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
4. Informed consent must be obtained.

Exclusion Criteria of health volunteers:

1. Other active skin diseases which may affect the condition assessment are present;
2. Those with severe, uncontrollable local or systemic acute or chronic infections;
3. Patients with a history of serious mental illness or family history;
4. Other reasons that the investigator considered inappropriate to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 4 patient groups

Psoriasis with Blood heat syndrome group

Experimental group

Description:

Participants in Psoriasis with Blood heat syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Clearing heat and Cooling blood, such as Cool blood detoxification Decoction I，Cool blood and activating blood prescription compound, Cool blood detoxification Decoction II, Cool blood activating blood Decoction, Tufu drink, Xiaoyin Decoction and etc., two times per day for 8 weeks.

Treatment:

Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy

Psoriasis with Blood stasis syndrome group

Experimental group

Description:

Participants in Psoriasis with Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Promoting blood circulation and Removing blood stasis, such as Huoxue Sanyu Xiaoyin Decoction, Cool blood detoxification Decoction III and etc., two times per day for 8 weeks.

Treatment:

Drug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy

Psoriasis with Non-Blood heat or Blood stasis syndrome group

Experimental group

Description:

Participants in Psoriasis with Non-Blood heat or Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of syndrome differentiation therapy two times per day for 8 weeks.

Treatment:

Drug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy

Healthy control group

No Intervention group

Description:

No Intervention.