Comparison of PSORI-CM01 Formula vs Gu Ben Hua Yu Formula Combined With AD-MSCs in Psoriasis

Launched by GUANGDONG PROVINCIAL HOSPITAL OF TRADITIONAL CHINESE MEDICINE · Mar 3, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for people with moderate to severe psoriasis, which is a skin condition that can cause red, scaly patches. The study will compare a traditional Chinese medicine formula called PSORI-CM01 with another formula, Gu Ben Hua Yu, that is combined with stem cells from healthy donors. Researchers want to see which treatment is safer and more effective for improving psoriasis symptoms. They are also interested in understanding what patients hope to gain from these treatments.

To participate in this trial, you need to be between 18 and 65 years old and have a specific level of psoriasis severity. However, some people may not qualify, such as those with certain skin lesions or serious medical conditions, including significant anxiety or depression. If you join the study, you can expect regular check-ups to monitor your health and how well the treatment is working. This trial is currently recruiting participants, and the findings will help guide future research on psoriasis treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1.patients with psoriasis vulgaris(PASI \> 7 or BSA \>10%); 2.18 to 65 years old; 3.written/signed informed consent.
• Exclusion Criteria:
• • 1. The skin lesions are seen alone on the patient's face, scalp, nails, wrinkles, glans, mucous membranes, palmar and plantar or guttate psoriasis;
• • 2. Acute progressive psoriasis, and erythroderma tendency;
• • 3. current (or within 1 year) pregnancy or lactation;
• • 4. 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;
• • 5. 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;
• • 6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction;
• • 7. allergy to anything else ever before;
• • 8. current registration in other clinical trials or participation within a month;
• • 9. 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;
• • 10. medical conditions assessed by investigators, that are not suitable for this clinical study.