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IRCT20150825023753N22 IRCT 2024-01-09 Shiraz University of Medical Sciences The effectiveness of oral Cicaglucal on wound healing and pruritus management in patients with Epidermolysis bullosa Investigating the effectiveness of oral Cicaglucal on wound healing and pruritus management in patients with Epidermolysis bullosa 2024-01-15 anticipated 15 Complete https://irct.ir/trial/74829 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Epidermolysis bullosa. Intervention group: Cicaglucal capsule is administered once a day for up to one month. In cases where patients are unable to take the medicine due to difficulty in swallowing the capsule, the capsule is opened and the contents of the capsule (powder) are given to the patient orally with water.. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: One year later To whom: Researchers Conditions: After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews. Where to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. How to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. Comments: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
public Dr. Mohammad Mahdi Parvizi
Zand Ave, Shahid Faghihi Hospital,
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 mmparvizi@gmail.com Shiraz University of Medical Sciences scientific Dr. Mohammad Mahdi Parvizi
Zand Ave, Shahid Faghihi Hospital,
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 mmparvizi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with epidermolysis bullosa who have been confirmed by a dermatologist Consent of the patient and the patient's parents to participate in the study The patient complains of skin sores and itching 5 years no limit Both Positive history of drug hypersensitivity Patients who have problems with swallowing any type of medication Q81 Epidermolysis bullosa Treatment - Drugs Intervention group: Cicaglucal capsule is administered once a day for up to one month. In cases where patients are unable to take the medicine due to difficulty in swallowing the capsule, the capsule is opened and the contents of the capsule (powder) are given to the patient orally with water. The number of wounds on the surface of the patient's body. Timepoint: Before drug administration and one month after drug administration. Method of measurement: Count the number of wounds. Severity of itching. Timepoint: Before drug administration and one month after drug administration. Method of measurement: Dynamic Pruritus Score (DPS). Overall improvement rate from the patient's point of view. Timepoint: One month after taking the drug. Method of measurement: Patient global impression of improvement(PGI-I). Overall improvement rate from the physician's point of view. Timepoint: One month after taking the drug. Method of measurement: Impression of improvement (CGI-I). Shiraz University of Medical Sciences Approved 2023-12-20 Ethics committee of Medical School of Shiraz University of Medical Sciences Medical School of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)