Back to resultsChinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy
Oral Chinese Herbal Medicine according with syndrome differentiation therapy
Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis Vulgaris, Chinese Medicine, Real World Study, Clearing heat and Cooling blood, Promoting blood circulation and Removing blood stasis
Eligibility Criteria
Inclusion Criteria of psoriatic:
- In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
- 18 to 65 years old, male or female patient;
- The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
- Informed consent must be obtained.
Exclusion Criteria of psoriatic:
- Patients with a history of serious mental illness or family history;
- Other reasons that the investigator considered inappropriate to participate in the study.
Inclusion Criteria of health volunteers:
- Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
- 18 to 65 years old, male or female patient;
- The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
- Informed consent must be obtained.
Exclusion Criteria of health volunteers:
- Other active skin diseases which may affect the condition assessment are present;
- Those with severe, uncontrollable local or systemic acute or chronic infections;
- Patients with a history of serious mental illness or family history;
- Other reasons that the investigator considered inappropriate to participate in the study.
Sites / Locations
- The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Beijing Hospital of Traditional Chinese Medicine
- The Second People's Hospital Affiliated to Fujian University of TCM
- Affiliated Hospital of Gansu University of traditional Chinese Medicine
- The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
- The First Affiliated Hospital of Guiyang College of TCM
- Shijiazhuang Hospital of Traditional Chinese Medicine
- First Affiliated Hospital of Heilongjiang Chinese Medicine University
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Wuhan No.1 Hospital
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Affiliated hospital of jiangxi university of traditional Chinese medicine
- The Second Affiliated Hospital of Jiangxi University of TCM
- Changhai Hospital
- Shanghai 10th People's Hospital
- Shanghai Dermatology Hospital
- Shanghai Yueyang Integrated Medicine Hospital
- Shanxi Provincial Hospital of Traditional Chinese Medicine
- Chinese Medicine Hospital Affiliated to Southwest Medical University
- Zhejiang Provincial Hospital of TCM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Psoriasis with Blood heat syndrome group
Psoriasis with Blood stasis syndrome group
Psoriasis with Non-Blood heat or Blood stasis syndrome group
Healthy control group
Arm 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.
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.
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.
No Intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 (%).
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)].
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.
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.
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).
CM symptom score
The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Full Information
NCT ID
NCT03942185
First Posted
May 7, 2019
Last Updated
May 7, 2019
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Zhejiang Provincial Hospital of TCM, Shanghai Dermatology Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Changhai Hospital, Shanghai 10th People's Hospital, Beijing Hospital of Traditional Chinese Medicine, Wuhan No.1 Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Chinese Medicine Hospital Affiliated to Southwest Medical University, First Affiliated Hospital of Heilongjiang Chinese Medicine University, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, The Second Affiliated Hospital of Jiangxi University of TCM, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The Guangxi Zhuang Autonomous Region Institute of Dermatology and control, The First Affiliated Hospital of Guiyang College of TCM, The Second People's Hospital Affiliated to Fujian University of TCM, Affiliated Hospital of Gansu University of traditional Chinese Medicine, Shanxi Provincial Hospital of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03942185
Brief Title
Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study
Official Title
Chinese Herbal Medicine for the Treatment of Psoriasis Vulgaris: a Real World Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Zhejiang Provincial Hospital of TCM, Shanghai Dermatology Hospital, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Changhai Hospital, Shanghai 10th People's Hospital, Beijing Hospital of Traditional Chinese Medicine, Wuhan No.1 Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Chinese Medicine Hospital Affiliated to Southwest Medical University, First Affiliated Hospital of Heilongjiang Chinese Medicine University, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, The Second Affiliated Hospital of Jiangxi University of TCM, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The Guangxi Zhuang Autonomous Region Institute of Dermatology and control, The First Affiliated Hospital of Guiyang College of TCM, The Second People's Hospital Affiliated to Fujian University of TCM, Affiliated Hospital of Gansu University of traditional Chinese Medicine, Shanxi Provincial Hospital of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis Vulgaris, Chinese Medicine, Real World Study, Clearing heat and Cooling blood, Promoting blood circulation and Removing blood stasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psoriasis with Blood heat syndrome group
Arm Type
Experimental
Arm 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.
Arm Title
Psoriasis with Blood stasis syndrome group
Arm Type
Experimental
Arm 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.
Arm Title
Psoriasis with Non-Blood heat or Blood stasis syndrome group
Arm Type
Experimental
Arm 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.
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
No Intervention.
Intervention Type
Drug
Intervention Name(s)
Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Chinese Herbal Medicine according with syndrome differentiation therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index
Description
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.
Time Frame
Up to 56 days after treatment
Secondary Outcome Measure Information:
Title
Body surface area (BSA)
Description
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 (%).
Time Frame
Up to 56 days after treatment
Title
Physician Global Assessment (PGA)
Description
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)].
Time Frame
Up to 56 days after treatment
Title
Dermatology Life quality index(DLQI)
Description
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.
Time Frame
Up to 56 days after treatment
Title
Patient-reported quality of life (PRQoL)
Description
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.
Time Frame
Up to 56 days after treatment
Title
Visual Analogue Score (VAS)
Description
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).
Time Frame
Up to 56 days after treatment
Title
CM symptom score
Description
The CM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Time Frame
Up to 56 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria of psoriatic:
In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
18 to 65 years old, male or female patient;
The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
Informed consent must be obtained.
Exclusion Criteria of psoriatic:
Patients with a history of serious mental illness or family history;
Other reasons that the investigator considered inappropriate to participate in the study.
Inclusion Criteria of health volunteers:
Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
18 to 65 years old, male or female patient;
The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
Informed consent must be obtained.
Exclusion Criteria of health volunteers:
Other active skin diseases which may affect the condition assessment are present;
Those with severe, uncontrollable local or systemic acute or chronic infections;
Patients with a history of serious mental illness or family history;
Other reasons that the investigator considered inappropriate to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Li
Phone
008618930568129
Email
18930568129@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Li
Phone
008613661956326
Email
13661956326@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Zhou
Organizational Affiliation
Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Hospital of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second People's Hospital Affiliated to Fujian University of TCM
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Affiliated Hospital of Gansu University of traditional Chinese Medicine
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
The Guangxi Zhuang Autonomous Region Institute of Dermatology and control
City
Nanning
State/Province
Guangxi
Country
China
Facility Name
The First Affiliated Hospital of Guiyang College of TCM
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Shijiazhuang Hospital of Traditional Chinese Medicine
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
First Affiliated Hospital of Heilongjiang Chinese Medicine University
City
Ha'erbin
State/Province
Heilongjiang
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Wuhan No.1 Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Jiangsu Province Hospital of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Affiliated hospital of jiangxi university of traditional Chinese medicine
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The Second Affiliated Hospital of Jiangxi University of TCM
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai 10th People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Yueyang Integrated Medicine Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanxi Provincial Hospital of Traditional Chinese Medicine
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Chinese Medicine Hospital Affiliated to Southwest Medical University
City
Luzhou
State/Province
Sichuan
Country
China
Facility Name
Zhejiang Provincial Hospital of TCM
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36189747
Citation
Sun X, Zhao H, Wang R, Li H, Wu Y, Ze K, Su Y, Li B, Li X. Psoriasis complicated with metabolic disorder is associated with traditional Chinese medicine syndrome types: a hospital-based retrospective case-control study. Curr Med Res Opin. 2023 Jan;39(1):19-25. doi: 10.1080/03007995.2022.2129803. Epub 2022 Oct 11.
Results Reference
derived
PubMed Identifier
31930095
Citation
Luo Y, Ru Y, Sun X, Zhou Y, Yang Y, Ma T, Xu R, Chen J, Zhou M, Ze K, Ju L, Wang Y, Yin Q, Wang R, Li B, Li X. Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol. Ann Transl Med. 2019 Nov;7(22):694. doi: 10.21037/atm.2019.10.46.
Results Reference
derived
Learn more about this trial
Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study
We'll reach out to this number within 24 hrs