Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study

Psoriasis Clinical Trial

Official title:

Chinese Herbal Medicine for the Treatment of Psoriasis Vulgaris: a Real World Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03942185
• Other study ID #: 2018YFC1705301
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2019
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Bin Li
• Phone: 008618930568129
• Email: 18930568129[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy
Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.
• Oral Chinese Herbal Medicine according with syndrome differentiation therapy
Oral Chinese Herbal Medicine according with syndrome differentiation therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.
• Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

Locations

Country	Name	City	State
China	Beijing Hospital of Traditional Chinese Medicine	Beijing	Beijing
China	The Second People's Hospital Affiliated to Fujian University of TCM	Fuzhou	Fujian
China	The First Affiliated Hospital of Guiyang College of TCM	Guiyang	Guizhou
China	First Affiliated Hospital of Heilongjiang Chinese Medicine University	Ha'erbin	Heilongjiang
China	Zhejiang Provincial Hospital of TCM	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine	Hefei	Anhui
China	Affiliated Hospital of Gansu University of traditional Chinese Medicine	Lanzhou	Gansu
China	Chinese Medicine Hospital Affiliated to Southwest Medical University	Luzhou	Sichuan
China	Affiliated hospital of jiangxi university of traditional Chinese medicine	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Jiangxi University of TCM	Nanchang	Jiangxi
China	Jiangsu Province Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	The Guangxi Zhuang Autonomous Region Institute of Dermatology and control	Nanning	Guangxi
China	Changhai Hospital	Shanghai	Shanghai
China	Shanghai 10th People's Hospital	Shanghai	Shanghai
China	Shanghai Dermatology Hospital	Shanghai	Shanghai
China	Shanghai Yueyang Integrated Medicine Hospital	Shanghai	Shanghai
China	Shijiazhuang Hospital of Traditional Chinese Medicine	Shijiazhuang	Hebei
China	Wuhan No.1 Hospital	Wuhan	Hubei
China	Shanxi Provincial Hospital of Traditional Chinese Medicine	Xi'an	Shanxi
China	The First Affiliated Hospital of Henan University of Traditional Chinese Medicine	Zhengzhou	Henan

Sponsors (20)

Lead Sponsor

Collaborator

Shanghai Yueyang Integrated Medicine Hospital

Affiliated Hospital of Gansu University of traditional Chinese Medicine, Affiliated hospital of jiangxi university of traditional Chinese medicine, Beijing Hospital of Traditional Chinese Medicine, Changhai Hospital, Chinese Medicine Hospital Affiliated to Southwest Medical University, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Jiangsu Province Hospital of Traditional Chinese Medicine, Shanghai 10th People's Hospital, Shanghai Dermatology Hospital, Shanxi Provincial Hospital of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital of Guiyang College of TCM, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Guangxi Zhuang Autonomous Region Institute of Dermatology and control, The Second Affiliated Hospital of Jiangxi University of TCM, The Second People's Hospital Affiliated to Fujian University of TCM, Wuhan No.1 Hospital, Zhejiang Provincial Hospital of TCM

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	CM symptom score	The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.	Up to 56 days after treatment