Back to resultsOral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome
Primary Purpose
Psoriasis Vulgaris
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jueyin granules
Jueyin Granules Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis Vulgaris, Jueyin granules, Blood heat syndrome, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
- Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
- Age between 18 and 65 years old;
- Those who voluntarily participate in the study and sign informed consent.
Exclusion Criteria:
- Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
- Other active skin diseases may affect the condition assessment;
- Received research drugs, biological agents and immunosuppressive agents within 1 month;
- 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
- During severe, uncontrollable local or systemic acute or chronic infections;
- Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;
- A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
- Such surgery will be required during major surgery or study during 8 weeks;
- Pregnant or lactating women;
- A person with a history of alcohol abuse, drug abuse or drug abuse;
- Have a history of serious mental illness or family history;
- Other reasons researchers believe that it is inappropriate to participate in this research.
Sites / Locations
- First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Beijing Hospital of Traditional Chinese Medicine
- Affiliated Hospital of Gansu University of Chinese Medicine
- Guangxi Zhuang Autonomous Region Dermatology Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oral Chinese medicine
Oral Chinese medicine placebo
Arm Description
Participants in experimental group will receive Jueyin granule two times daily after meals three times per week for 8 weeks.
Participants in placebo group will receive Jueyin granule placebo two times daily after meals three times per week for 8 weeks.
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).
TCM symptom score
The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.
Full Information
NCT ID
NCT03961230
First Posted
May 22, 2019
Last Updated
May 22, 2019
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Beijing Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Affiliated Hospital of Gansu University of Chinese Medicine, Guangxi Zhuang Autonomous Region Dermatology Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03961230
Brief Title
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome
Official Title
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
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
Beijing Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Affiliated Hospital of Gansu University of Chinese Medicine, Guangxi Zhuang Autonomous Region Dermatology Hospital
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
We designed this study as a multicenter, randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of psoriasis with blood stasis syndrome.
Detailed Description
Psoriasis is a chronic, relapsing, inflammatory, multisystem disease characterized by infiltration of inflammatory cells, hyperplasia of epidermal keratinocytes, and abnormal differentiation. Latest data estimate that the prevalence of psoriasis in adults has increased to 11.43%, which shows that the control and treatment of psoriasis is still insufficient. Recent studies showed that traditional Chinese medicine (TCM) is one of the effective methods for the treatment of psoriasis. More and more evidences support the recognition of psoriasis not only affects the skin, but also suffers a chronic multisystem inflammation. Chinese medicine believes that the blood heat is the root of the onset of psoriasis, so the treatment of psoriasis should focus on the method of clearing heat and cooling blood. Therefore, the method of promoting clearing heat and cooling blood. has always been the focus of TCM treatment and prevention of psoriasis. This multicenter, randomized, double-blind, placebo-controlled trial will provide high-quality clinical evidences for evaluating the efficacy, safety and recurrence rate of Jueyin granule, a representative prescription for the treatment of psoriasis with blood heat syndrome, in the treatment of psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Psoriasis Vulgaris, Jueyin granules, Blood heat syndrome, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Chinese medicine
Arm Type
Experimental
Arm Description
Participants in experimental group will receive Jueyin granule two times daily after meals three times per week for 8 weeks.
Arm Title
Oral Chinese medicine placebo
Arm Type
Placebo Comparator
Arm Description
Participants in placebo group will receive Jueyin granule placebo two times daily after meals three times per week for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Jueyin granules
Other Intervention Name(s)
Chinese Herbal Medicine
Intervention Description
Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
Intervention Type
Drug
Intervention Name(s)
Jueyin Granules Placebo
Other Intervention Name(s)
Chinese Herbal Medicine
Intervention Description
Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
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
TCM symptom score
Description
The TCM 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
No
Eligibility Criteria
Inclusion Criteria:
Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);
Age between 18 and 65 years old;
Those who voluntarily participate in the study and sign informed consent.
Exclusion Criteria:
Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
Other active skin diseases may affect the condition assessment;
Received research drugs, biological agents and immunosuppressive agents within 1 month;
2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
During severe, uncontrollable local or systemic acute or chronic infections;
Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;
A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
Such surgery will be required during major surgery or study during 8 weeks;
Pregnant or lactating women;
A person with a history of alcohol abuse, drug abuse or drug abuse;
Have a history of serious mental illness or family history;
Other reasons researchers believe that it is inappropriate to participate in this research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Li
Phone
0086-021-55981301
Email
18930568129@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kan Ze
Phone
0086-021-65161782-3137
Email
zekan1@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
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
Affiliated Hospital of Gansu University of Chinese Medicine
City
Nanchang
State/Province
Gansu
Country
China
Facility Name
Guangxi Zhuang Autonomous Region Dermatology Hospital
City
Nanning
State/Province
Guizhou
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32351609
Citation
Li S, Zhang C, Zhang HY, Zhou M, Wang SN, Xu R, Zhou DM, Ji YR, Lv JJ, Yin QF, Wang RP, Li W, Liu YP, Wang JF, Li B, Li X. Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2020 Apr 9;2020:8942301. doi: 10.1155/2020/8942301. eCollection 2020.
Results Reference
derived
Learn more about this trial
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome
We'll reach out to this number within 24 hrs