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Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome

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ClinicalTrials.gov Identifier: NCT03961230
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
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
Information provided by (Responsible Party):
Shanghai Yueyang Integrated Medicine Hospital

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.

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Jueyin granules Drug: Jueyin Granules Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Heat Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral Chinese medicine
Participants in experimental group will receive Jueyin granule two times daily after meals three times per week for 8 weeks.
Drug: Jueyin granules
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.
Other Name: Chinese Herbal Medicine

Placebo Comparator: Oral Chinese medicine placebo
Participants in placebo group will receive Jueyin granule placebo two times daily after meals three times per week for 8 weeks.
Drug: Jueyin Granules Placebo
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.
Other Name: Chinese Herbal Medicine




Primary Outcome Measures :
  1. Psoriasis area and severity index [ Time Frame: Up to 56 days after treatment. ]
    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 :
  1. Body surface area (BSA) [ Time Frame: Up to 56 days after treatment. ]
    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 (%)

  2. Physician Global Assessment (PGA) [ Time Frame: Up to 56 days after treatment. ]
    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)].

  3. Dermatology Life quality index(DLQI) [ Time Frame: Up to 56 days after treatment. ]
    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.

  4. Patient-reported quality of life (PRQoL) [ Time Frame: Up to 56 days after treatment. ]
    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.

  5. Visual Analogue Score (VAS) [ Time Frame: Up to 56 days after treatment. ]
    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).

  6. TCM symptom score [ Time Frame: Up to 56 days after treatment. ]
    The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961230


Contacts
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Contact: Bin Li 0086-021-55981301 18930568129@163.com
Contact: Kan Ze 0086-021-65161782-3137 zekan1@163.com

Locations
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China, Anhui
First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, China
China, Beijing
Beijing Hospital of Traditional Chinese Medicine
Beijing, Beijing, China
China, Gansu
Affiliated Hospital of Gansu University of Chinese Medicine
Nanchang, Gansu, China
China, Guizhou
Guangxi Zhuang Autonomous Region Dermatology Hospital
Nanning, Guizhou, China
Sponsors and Collaborators
Shanghai Yueyang Integrated Medicine Hospital
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
Investigators
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Study Chair: Jia Zhou Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai

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Responsible Party: Shanghai Yueyang Integrated Medicine Hospital
ClinicalTrials.gov Identifier: NCT03961230     History of Changes
Other Study ID Numbers: 2018YFC1705302
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai Yueyang Integrated Medicine Hospital:
Psoriasis Vulgaris
Jueyin granules
Blood heat syndrome
Randomized controlled trial

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases