Effect of Real and Sham Acupoint Catgut Embedding on Psoriasis Vulgaris With Overweight/Obesity: A Pilot Study of Randomized Controlled Trial

Phase 1

Recruiting

• Conditions: Psoriasis Vulgaris With Overweight/Obesity

• Registration Number: ITMCTR2100004589
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine/The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate of PASI 50;

Secondary Outcome Measures

Name	Time	Method
Physician's Global Assessment;Waist Circumference;Body Weight;Body Mass Index;Waist-to-Hip Ratio;Response rate of PASI 90;Impact of Weight on Quality of Life-Lite;Dermatology Life Quality Index;Psoriasis Area and Severity Index;Visual Analog Scale;Response rate of PASI 75;Hip Crcumference;Psoriasis Vulgaris Symptoms Scale;