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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03942198
Other study ID # 2018YFC1705303-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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 0086-021-55981301
Email 18930568129@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 216
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Taodan 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.
Taodan 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.

Locations

Country Name City State
China First Affiliated Hospital of Heilongjiang Chinese Medicine University Harbin Heilongjiang
China Affiliated hospital of jiangxi university of traditional Chinese medicine Nanchang Jiangxi
China Shanghai Yueyang Integrated Medicine Hospital Shanghai Shanghai
China Shijiazhuang Hospital of Traditional Chinese Medicine Shijiazhuang He Bei
China Shanxi Provincial Hospital of Traditional Chinese Medicine Xi'an Shanxi

Sponsors (5)

Lead Sponsor Collaborator
Shanghai Yueyang Integrated Medicine Hospital Affiliated hospital of jiangxi university of traditional Chinese medicine, Heilongjiang University of Chinese Medicine, Shaanxi Provincial Hospital of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

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