ITMCTR2100004589RecruitingPhase 1
Efficacy and Mechanism Exploration of Acupoint Catgut Embedding for Psoriasis Vulgaris with Overweight/Obesity
Guangdong Provincial Hospital of Chinese Medicine/The Second Affiliated Hospital of Guangzhou University of Chinese Medicine0 sitesStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional study
Eligibility Criteria
- Ages
- 18 to 65 (—)
- Sex
- All
Inclusion Criteria
- •1. The patient meets the diagnostic criteria of western medicine for psoriasis vulgaris and the diagnostic criteria of spleen deficiency dampness and blood stasis syndrome in Traditional Chinese Medicine;
- •2. The condition of patients is in a stationary phase;
- •3. PASI 1 to 10 and BSA <= 20%;
- •4. BMI >=24 (kg/m2) or waist circumference: male >= 90cm, female >= 85cm;
- •5. Aged 18 to 65 years old;
- •6. Patients who voluntarily participate in the study and sign the informed consent.
Exclusion Criteria
- •1. Articular, pustular, erythrodermal, drip, progressive psoriasis and psoriasis in specific sites, including face, scalp, fingernails, folds, glans, and palmoplantar;
- •2. Secondary overweight or obesity caused by hypothyroidism, polycystic ovary syndrome, insulinoma, hypercortisolism and drugs;
- •3. Women who are pregnant, lactating, or planning to become pregnant during the study period;
- •4. Patients with severe primary diseases such as circulatory, respiratory, digestive , urinary, endocrine and hematopoietic system, which cannot be controlled by conventional medication, patients with diabetes or tumor, and patients with severe infection, water, electrolyte and acid-base balance disorders. Or patients whose clinical test indicators is one of the following conditions: The increase of alanine aminotransferase or aspartate aminotransferase > 1.5 ULN; the increase of creatinine > 1.5 ULN; the increase of hemoglobin > 20g/L of ULN; the decrease of platelet count < 75 x 10^9/L; the decrease of white blood cell count < 3 x10^9/L; the increase of blood potassium > 5.5mmol/L or the decrease of blood potassium < 3 mmol/L, or other abnormal laboratory tests, the researcher judged that it was not suitable for patients to participate in this trial;
- •5. Patients who are known to be allergic to surgical sutures or have skin ulcers, infections, scars, or tumors at the acupoint site;
- •6. Patients who had previously received acupoint catgut embedding therapy; Patients who took drugs, surgery and other methods to lose weight or whose weight loss was more than 5% within 12 weeks;
- •7. Those who have been treated with hormones, retinoic acid and other topical drugs within 2 weeks; those who have received systemic therapy or ultraviolet light therapy within 4 weeks; those who have been treated with biological agents within 12 weeks;
- •8. Those who are participating in other drug clinical trials or have participated in other clinical trials within 1 month;
- •9. The standard score of psychological evaluation scale: SAS > 50 or SDS > 53, or combined with other mental diseases;
- •10. Other conditions that the investigator deems inappropriate for participation in the study.
Investigators
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