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IRCT20220321054336N1 IRCT 2022-04-09 Tehran University of Medical Sciences Evaluation of the effectiveness of topical product containing henna and turmeric with Persian medicine based formulation in patients with contact dermatitis. Triple-blind clinical trial Comparison of the effectiveness of topical product containing henna and turmeric with a Persian medicine based formulation with placebo in patients with contact dermatitis. Triple-blind clinical trial 2022-05-22 anticipated 33 Complete https://irct.ir/trial/62629 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we used Random Allocation software for randomization. This software is able to generate random blocks that we will use this method for randomization. Randomization is done individually using 5-unit blocks. The random sequence of samples will be performed equally as Intervention and Placebo groups using this software. For allocation concealment, sealed envelopes will be used. In this method, each of the random sequences written on a card and they are placed in the envelopes, respectively. Finally, the lid of the envelopes is glued and placed in a box, respectively. At the registration time, based on the order in which eligible participants enter the study, one of the envelopes of their choice will be opened and their assigned group will be revealed, Blinding description: drug and placebo cans were coded by an expert person in the research center. Researchers, patients, data collectors, and evaluators assess the outcome, are not aware of the contents of the package and grouping, and samples were delivered at random to the patient. Patients received the number to their referral and entered the study. The number of patients was randomly selected by computer and divided into two groups. 2-3 contact dermatitis. Intervention 1: According to traditional sources and published articles, three components of turmeric, henna and Zaravand were selected to prepare the formulation. Extraction of each ingredient is done separately with water and ethanol solvents. The extracts are mixed in proportions of 3, 2 and 1 of turmeric, henna and Zaravand extracts and inserted with a concentration of 3-6% in a suitable base (cold cream). The ratio of components in the formulation was selected according to the traditional sources related to the Marham Ahmar formulation and with more emphasis on turmeric and reducing the possible toxicity of Zaravand. Also, the percentage of extract in the cream base was selected based on existing studies that have shown the effectiveness of turmeric and henna in skin problems such as eczema.The dose range is mentioned due to the uncertainty of the stability of the product and if the formulation is stable and the amount of Aristolochic acid is determined, a higher percentage of the extract in the formulation will be used. Patients are adults and meet the inclusion criteria. Patients are asked to use the product twice a day, one finger size (FTU = 1) at the site of skin lesions. Patients are given general advice about skincare in contact dermatitis, such as using gloves at work or using lukewarm water and mild detergents for rinsing. Intervention 2: The placebo is prepared using the base of the medicinal product (cold cream), without adding an extract, and to simulate the placebo with the drug in appearance, a few drops of permissible dye will be added. The medicine and placebo will be packed in exactly the same cans and then coded by the pharmacist. Yes - There is a plan to make this available What will be shared: All impersonal data of the participants without any name; Information on the main implications and all the information obtained from the research was published in the article. When: In the relevant article after its publication To whom: Everyone who has access to the published article Conditions: After publication in the journal Where to obtain: To the text of the published article or contact Dr. Shabnam Khatami via email at khatami.shabnam.188@gmail.com How to obtain: sending e mail to Dr Shabnam Khatami Comments:
public Shabnam Khatami
No27,North Sarparast St, West Taleghani Ave, School of Persian Medicine
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 khatami.shabnsm.188@gmail.com Tehran University of Medical Sciences scientific Laila Shirbeigi
No27, North Sarparast St, West Taleghani Ave, School of Persian Medicine
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 l.shirbeigi@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 years and above Acute or recurrent contact dermatitis in a person with a history of mild to moderate contact dermatitis (baseline Three Item Severity score in the range of 1 to 6) • Declare the written consent of the patient to participate in the study and the desire to attend regular treatment and follow-up courses • Have a minimum score of one for the redness and itching option in the Three Item Severity score 18 years no limit Both Other types of dermatitis except contact dermatitis Use of topical dermatitis medications (except moisturizers) in the last 2 weeks or systemic medications in the last 4 weeks Taking steroids or systemic immunosuppressants with any indication • Pregnant and lactating women • Severe contact dermatitis (Three Item Severity = 9) • Alcohol or drug addiction • Heart disease, kidney disease or asthma • Active skin disease other than contact dermatitis • History of allergies to topical medications or cosmetics (with documentation) Tattooing, scarring, and hyperpigmentation at the lesion site History of any malignant disease or active cancer G6PD enzyme deficiency L24 Irritant contact dermatitis Treatment - Drugs Placebo According to traditional sources and published articles, three components of turmeric, henna and Zaravand were selected to prepare the formulation. Extraction of each ingredient is done separately with water and ethanol solvents. The extracts are mixed in proportions of 3, 2 and 1 of turmeric, henna and Zaravand extracts and inserted with a concentration of 3-6% in a suitable base (cold cream). The ratio of components in the formulation was selected according to the traditional sources related to the Marham Ahmar formulation and with more emphasis on turmeric and reducing the possible toxicity of Zaravand. Also, the percentage of extract in the cream base was selected based on existing studies that have shown the effectiveness of turmeric and henna in skin problems such as eczema.The dose range is mentioned due to the uncertainty of the stability of the product and if the formulation is stable and the amount of Aristolochic acid is determined, a higher percentage of the extract in the formulation will be used. Patients are adults and meet the inclusion criteria. Patients are asked to use the product twice a day, one finger size (FTU = 1) at the site of skin lesions. Patients are given general advice about skincare in contact dermatitis, such as using gloves at work or using lukewarm water and mild detergents for rinsing. The placebo is prepared using the base of the medicinal product (cold cream), without adding an extract, and to simulate the placebo with the drug in appearance, a few drops of permissible dye will be added. The medicine and placebo will be packed in exactly the same cans and then coded by the pharmacist Disease severity score on a three-item severity scale. Timepoint: Before the start of the study and2 and 4 weeks after the intervention. Method of measurement: Use a three-item intensity score(TIS). Itching intensity score. Timepoint: Before the start of the study and2 and 4 weeks after the intervention. Method of measurement: Use Visual Analogue Scale(VAS). Trans epidermal water loss. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580. Epidermal moisture. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580. Melanin content. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580. Hemoglobin content. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580. Sebum content. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580. Temperature. Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580. Surface acidity of the lesion(PH). Timepoint: Before the start of the study and 4 weeks after the intervention. Method of measurement: Use Cutameter M P 580. Determining the effectiveness of the studied drug in comparison with placebo on the quality of life of patients. Timepoint: 4 weeks after taking topical Persian medicine drug. Method of measurement: Use of Dermatology Life Quality Index (DLQI) questionnaire. Determining the side effects of the studied drug. Timepoint: 4 weeks after taking topical Persian medicine drug. Method of measurement: common Terminology Criteria for Adverse Events questionnaire. Tehran University of Medical Sciences Approved 2022-03-19 Research ethics committees of school of medicine Tehran University of Medical sciences Room 605,sixth floor, the headquarters of Tehran University of Medical Sciences, The intersection of Keshavarz Blvd and Ghods St. Tehran Tehran Iran (Islamic Republic of)