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IRCT20191221045845N1 IRCT 2020-01-29 Yazd University of Medical Sciences The effect of medicinal plants on the leishmaniosis Evaluation of the effect of two herbal products (blend of vinegar, Plantago ovata and cotton) in comparison with placebo in patients with standard treatment of leishmaniasis in rural type center. 2020-01-15 anticipated 132 Complete https://irct.ir/trial/44918 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization envelops shuffling, Blinding description: To blind the participants and the clinical caregiver, the drugs are labeled with codes 1, 2, and 3 (placebo). The patient and the clinical caregiver and principal investigator are unaware of the type of drug. 2-3 Cutaneous leishmaniasis. Intervention 1: Intervention group: Standard treatment plus cream (topical medicinal product) containing extract of cotton plant is administered twice daily for 8 weeks. Intervention 2: Intervention group: Standard treatment plus cream (topical medicinal product) containing the combination of plantago ovata and vinegar is given twice daily for 8 weeks. Intervention 3: Control group: Standard treatment plus placebo is given twice daily for 8 weeks. Yes - There is a plan to make this available What will be shared: Monitoring information during the study When: Upon first request or about a week To whom: Applicant's subordinate authorities Conditions: Proof, Understanding and Exploitation Where to obtain: Person responsible for updating information How to obtain: Request the person responsible for the public accountability of the trial Comments: -
public Majid Emtiazy
school of iranian medicine, Imam Khomeini Ave,Ardekan.
Ardekan Iran (Islamic Republic of) 8951737915 +98 35 3223 8915 dr.emtiazy@yahoo.com Yazd University of Medical Sciences scientific Mohammad Ebrahimzade
Yazd University of Medical Sciences
yazd Iran (Islamic Republic of) 8916978477 03537240171-5 mohammad110eb@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Proof of cutaneous leishmaniasis through smear The patients should not be less than 6 years old and not more than 60 years old The lesion size should be less than 3 cm The duration of the illness is less than 12 weeks No lesion on the face Not having any other anti-leishmaniasis medication in the past 4 weeks Don't be pregnant or breastfeeding Do not have severe skin disease such as eczema, psoriasis or chronic dermatitis of unknown origin Has no serious, chronic or malignant disease and is not under chemotherapy treatment Has 4 or less lesions in the body No travel history 6 months ago 6 years 60 years Both The type of cutaneous leishmaniasis may be complicated, with complications such as a patient with mucosal leishmaniasis Having 5 lesions and more Lesions greater than 3 cm Subcutaneous nodules Regional adenopathy larger than 1 cm People with immunodeficiency Children under 6 years Women in Lactation and Pregnancy sporotrichoid leishmaniasis or satellite lesions Patients with ulcers on the face Patients with a history of drug allergy to antimony compounds Patients who have had more than three months since their first skin lesions appeared Patients who have used any method of treatment for cutaneous leishmaniasis during the past month Patients with a history of travel to other areas of leishmaniasis in the past 6 months as well as those of urban leishmaniasis B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Treatment - Other Intervention group: Standard treatment plus cream (topical medicinal product) containing extract of cotton plant is administered twice daily for 8 weeks. Intervention group: Standard treatment plus cream (topical medicinal product) containing the combination of plantago ovata and vinegar is given twice daily for 8 weeks. Control group: Standard treatment plus placebo is given twice daily for 8 weeks. Leishmaniasis lesion area. Timepoint: Before treatment and then every week until healing or the eighth week. Method of measurement: Mathematical calculations with mm-square scale. Wound healing time. Timepoint: End of treatment. Method of measurement: Time between start and end of treatment in days. Yazd University of Medical Sciences Approved 2019-10-08 Ethics committee of yazd University of Medical Sciences school of Iranian Medicine,Imam Khomeini street, ardekan, yazd yazd Yazd Iran (Islamic Republic of)