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Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome

Primary Purpose

Psoriasis Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Taodan Granules
Taodan Granules Placebo
Sponsored by
Shanghai Yueyang Integrated Medicine Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Plaque psoriasis, Promoting blood circulation for removing blood stasis, Randomized controlled trial, Taodan Granules

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
  2. 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);
  3. Age between 18 and 65 years old;
  4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria:

  1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
  2. Other active skin diseases may affect the condition assessment;
  3. Received research drugs, biological agents and immunosuppressive agents within 1 month;
  4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
  5. During severe, uncontrollable local or systemic acute or chronic infections;
  6. 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;
  7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
  8. Such surgery will be required during major surgery or study during 8 weeks;
  9. Pregnant or lactating women;
  10. A person with a history of alcohol abuse, drug abuse or drug abuse;
  11. Have a history of serious mental illness or family history;
  12. Other reasons researchers believe that it is inappropriate to participate in this research.

Sites / Locations

  • Shijiazhuang Hospital of Traditional Chinese Medicine
  • First Affiliated Hospital of Heilongjiang Chinese Medicine University
  • Affiliated hospital of jiangxi university of traditional Chinese medicine
  • Shanghai Yueyang Integrated Medicine Hospital
  • Shanxi Provincial Hospital of Traditional Chinese Medicine

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 Taodan granule two times daily after meals three times per week for 8 weeks.

Participants in placebo group will receive Taodan granule two times daily after meals three times per week for 8 weeks.

Outcomes

Primary Outcome Measures

Psoriasis area and severity index (PASI)
Psoriasis Area and Severity Index (PASI) 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 body surface area (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)
Patient-reported quality of life (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

First Posted
May 7, 2019
Last Updated
May 7, 2019
Sponsor
Shanghai Yueyang Integrated Medicine Hospital
Collaborators
Shaanxi Provincial Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine, Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03942198
Brief Title
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome
Official Title
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis 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
Shaanxi Provincial Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine, Heilongjiang University of 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
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. In addition, blood-stasis accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for so long, which similar to many metabolic related diseases. Therefore, the method of promoting blood circulation and removing blood stasis 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 Taodan granule, a representative prescription for the treatment of psoriasis with blood stasis 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
Plaque psoriasis, Promoting blood circulation for removing blood stasis, Randomized controlled trial, Taodan Granules

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Chinese medicine
Arm Type
Experimental
Arm Description
Participants in experimental group will receive Taodan 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 Taodan granule two times daily after meals three times per week for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Taodan 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)
Taodan 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 (PASI)
Description
Psoriasis Area and Severity Index (PASI) 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 body surface area (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
Patient-reported quality of life (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
Jie Chen
Phone
0086-021-65161782-3137
Email
dercj366@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
Shijiazhuang Hospital of Traditional Chinese Medicine
City
Shijiazhuang
State/Province
He Bei
Country
China
Facility Name
First Affiliated Hospital of Heilongjiang Chinese Medicine University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Affiliated hospital of jiangxi university of traditional Chinese medicine
City
Nanchang
State/Province
Jiangxi
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

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31700924
Citation
Ru Y, Yan XN, Yang SQ, Gong LP, Li LE, Chen J, Zhao YD, An YP, Huang G, Zhang JF, Yin QF, Wang RP, Li X, Li B. Oral Taodan granules for mild-to-moderate psoriasis vulgaris: protocol for a randomized, double-blind, multicenter clinical trial. Ann Transl Med. 2019 Sep;7(18):488. doi: 10.21037/atm.2019.09.05.
Results Reference
derived

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Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome

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