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IRCT20210218050404N3 IRCT 2022-02-14 Fasa University of Medical Sciences Therapeutic effects of herbs on eczema SFE Evaluation of anti-inflammatory effects of ZAX.1400.EC.02 drug on skin inflammation in patients with eczema 2022-03-05 anticipated 110 Complete https://irct.ir/trial/58077 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is performed on patients with eczema referred to the partner medical centers in the project. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, sex, severity of the disease and symptoms, and randomly, using the patient code numbers, one group is group A (herbal medicine) and one group is group B (standard medicine). For randomization, the permutation block method with the number of six blocks is done using Random allocation software, Blinding description: To blind the study, after the patient enters the study, the doctor prescribes A (drug) or B (placebo) based on the randomized form. The doctor's prescription is prescribed in the same packages. Clinical caregivers are unaware of the coding assigned to each patient. The person in charge of drug delivery and the patient, the doctor, the person in charge of evaluating the consequences will not know about the codings. The results of the two groups under the headings of groups A and B will be submitted to the statistical analyst. 2-3 Eczema. Intervention 1: Intervention group: ZAX.1400.EC.02 drug composition, topical and cream-based, twice-daily use for 21 days, and patients are evaluated for up to 42 days. Intervention 2: Control group: Betamethasone is used topically, twice daily, for 21 days, and patients are evaluated for up to 42 days. Yes - There is a plan to make this available What will be shared: Some of the information obtained will be available based on changes in initial outcomes When: Start of access period 6 months after production of results To whom: People engaged in research in medical universities of the country Conditions: The methods and data contained in this clinical trial should be used solely to advance similar projects. It is also necessary to mention the research center of this study (Fasa University of Medical Sciences) if the information is used Where to obtain: Amin Dakhili Ardestani, Email Address: Amindakhiliardestani@yahoo.com Contact Number: 09228584505 Address: Fasa University, Ibn Sina Square, Fasa University of Medical Sciences and Health Services How to obtain: 1. Contacting the general respondent of study 2. Sending his formal request to the respondent 3. The application form in the University Research Council 4. In case of a positive response from the council, it will be provided to the applicant in accordance with the ethical principles. 5. The total duration of the process is 20 days. Comments:
public Amin Dakhili Ardestani
Ibn Sina square, Fasa
Fasa Iran (Islamic Republic of) 7461686688 0715335907 amindakhiliardestani@yahoo.com Fasa University of Medical Sciences scientific Dr Seyyed Amin Kouhpayeh
Ibn Sina Square, Fasa.
Fasa Iran (Islamic Republic of) 7461686688 +98 71 5335 9507 kouhpayeha@gmail.com Fasa University of Medical Sciences Iran (Islamic Republic of) Diagnosis of the disease by a doctor Both sexes (male and female) Having informed and written consent to participate in the study 18 years 60 years Both Pregnancy and lactation Food and health allergies بروز تاول و عفونت ناشی از بیماری Disagreement of the physician directly responsible for the patient L23.9 Allergic contact dermatitis, unspecified cause Treatment - Drugs Treatment - Drugs Intervention group: ZAX.1400.EC.02 drug composition, topical and cream-based, twice-daily use for 21 days, and patients are evaluated for up to 42 days. Control group: Betamethasone is used topically, twice daily, for 21 days, and patients are evaluated for up to 42 days. Extent of lesion. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Determine the area in CM2. Redness of the skin. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Swelling of the skin. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Scaling. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Itching. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Skin dryness. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: VAS checklist. Skin irritation. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Skin scratches. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Skin scars. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Skin thickness. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Skin rash. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: Visual Analogue Scale checklist. Recovery time. Timepoint: daily. Method of measurement: By day by checklist. Quality of Life. Timepoint: In seven turns; Days zero, 7, 14, 21, 28, 35 and 42. Method of measurement: DLQI form. Fasa University of Medical Sciences Approved 2022-01-05 Ethics Committee of Fasa University of Medical Sciences Ibn Sina square, Fasa. Fasa Fars Iran (Islamic Republic of)