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IRCT20200707048040N1 IRCT 2020-08-08 Shahid Beheshti University of Medical Sciences The effect of Portulaca oleracea syrup on mild to moderate chronic hand dermatitis Evaluation of the efficacy and safety of Purslane (Portulaca oleracea) Product on Clinical Symptoms of Mild to Moderate Chronic Hand Dermatitis 2020-08-20 anticipated 70 Complete https://irct.ir/trial/49683 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: Randomization unit block: Individual Randomization tool: Random number table How to make a sequence: In a random number table, a number is randomly selected from the table and arranged in rows or columns in the up and down and left or right numbers. Next are selected. Because the number of modes of 4 blocks for two groups is 6 modes, numbers higher than 6 and zero are ignored in the table and each digit specifies the desired block, Blinding description: Portulaca oleracea and placebo have been coded for blinding. The patient, researcher, and analyzer are also unaware of the type of drug administered. 3 mild to moderate chronic dermatitis. Intervention 1: Intervention group: Intervention group: Recipient of Portulaca oleracea syrup (25 mg/ ml) 10 cc three times a day for 4 weeks orally prepared to contain aqueous extract of Portulaca oleracea and prepared by the traditional pharmacy group of Shahid Beheshti School of Traditional Medicine, Samin Vaseline cream produced by Golafshan company should be rubbed on the dermatitis area every night as a surface layer for 4 weeks. Intervention 2: Control group: Control group: 10 cc placebo syrup recipient three times a day for 4 weeks orally and prepared by the traditional pharmacy group of Shahid Beheshti School of Traditional Medicine. Rub a surface layer for 4 weeks. Yes - There is a plan to make this available What will be shared: Publication of the results in the form of a doctoral dissertation and an ISI article When: After PhD thesis defence To whom: public Conditions: for research reasons Where to obtain: Shahid Beheshti University of Medical Sciences How to obtain: Approval of the relevant responsible Comments:
public Sedigheh Rastegar
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rastegar.sedigheh54@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Sedigheh Rastegar
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rastegar.sedigheh54@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with chronic unilateral or bilateral hand dermatitis, including occupational dermatitis, allergic dermatitis or irritative dermatitis Age range 18 to 70 years Willingness and satisfaction to participate in the study Referred to traditional medicine center 18 years 70 years Both Breastfeeding Pregnancy Patients with severe dermatitis Patients with underlying diseases such as cardiovascular failure, diabetes, immune deficiency, autoimmune diseases, spinal cord diseases Patients taking medication for their other illnesses Patients who develop another acute illness during treatment Patients who have an infection at the site of their dermatitis Patients who are allergic to Portulaca oleracea L30.9 Dermatitis, unspecified Treatment - Drugs Placebo Intervention group: Intervention group: Recipient of Portulaca oleracea syrup (25 mg/ ml) 10 cc three times a day for 4 weeks orally prepared to contain aqueous extract of Portulaca oleracea and prepared by the traditional pharmacy group of Shahid Beheshti School of Traditional Medicine, Samin Vaseline cream produced by Golafshan company should be rubbed on the dermatitis area every night as a surface layer for 4 weeks. Control group: Control group: 10 cc placebo syrup recipient three times a day for 4 weeks orally and prepared by the traditional pharmacy group of Shahid Beheshti School of Traditional Medicine. Rub a surface layer for 4 weeks. Erythema. Timepoint: Week zero, the end of the fourth and eighth weeks. Method of measurement: HECSI Scale. Edema. Timepoint: Week zero, the end of the fourth and eighth weeks. Method of measurement: HECSI Scale. Fissure. Timepoint: Week zero, the end of the fourth and eighth weeks. Method of measurement: HECSI Scale. Scaling. Timepoint: Week zero, the end of the fourth and eighth weeks. Method of measurement: HECSI Scale. Itching. Timepoint: Week zero, the end of the second, fourth and eighth weeks. Method of measurement: VAS Scale. Dryness. Timepoint: Week zero, the end of the second, fourth and eighth weeks. Method of measurement: VAS Scale. Skin thickness. Timepoint: Week zero, the end of the second, fourth and eighth weeks. Method of measurement: VAS Scale. Drug side effects. Timepoint: Week zero, the end of the second, fourth and eighth weeks. Method of measurement: Question from the patient. Dermatology life quality index. Timepoint: Week zero, the end of the fourth and eighth weeks. Method of measurement: DLQI questionnair. Patients' overall satisfaction with treatment. Timepoint: End of the fourth week. Method of measurement: Likert Scale. Recurrence of symptoms after treatment. Timepoint: the end of the eighth week. Method of measurement: Question from the patient. Shahid Beheshti University of Medical Sciences Approved 2020-06-28 Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak, Yaman Ave., Sh. Aarabi Ave., Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)