Status:
UNKNOWN
Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis
Lead Sponsor:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions:
Traditional Chinese Medicine
Drug Effect
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate and compare the safety and efficacy of PSORI-CM01 formula vs Gu Ben Hua Yu formula combined with Expanded Allogeneic AD-MSCs in patients with moderate to sever...
Detailed Description
Psoriasis is an immune-mediated, genetic disease manifesting in the skin or joints or both. Treatment modalities are chosen on the basis of disease severity, relevant comorbidities, patient preference...
Eligibility Criteria
Inclusion
- patients with psoriasis vulgaris(PASI \> 7 or BSA \>10%); 2.18 to 65 years old; 3.written/signed informed consent.
Exclusion
- The skin lesions are seen alone on the patient's face, scalp, nails, wrinkles, glans, mucous membranes, palmar and plantar or guttate psoriasis;
- Acute progressive psoriasis, and erythroderma tendency;
- current (or within 1 year) pregnancy or lactation;
- current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) \> 50 or the Self-rating Depression Scale (SDS) \> 53, or with other psychiatric disorders;
- With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases,infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+\> 2.9 mmol/L or \< 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit;Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0\*10\^9/L; White blood cell less than 3.0\*10\^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study;
- Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction;
- allergy to anything else ever before;
- current registration in other clinical trials or participation within a month;
- topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
- medical conditions assessed by investigators, that are not suitable for this clinical study.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04785027
Start Date
March 17 2021
End Date
September 30 2024
Last Update
August 24 2023
Active Locations (1)
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1
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China, 510000