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IRCT20201226049841N1 IRCT 2021-01-26 Marham Sazan Moghan Daroo Company Evaluation of the effect of Oak powder for the treatment of leishmaniasis. Evaluation of the effect of herbal medicine prepared from Oak in human phase in patients with cutaneous leishmaniasis. 2021-02-03 anticipated 60 Complete https://irct.ir/trial/53258 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: In the following research, 60 leishmaniasis positive cases are going to be examined by a dermatologist and in case of confirmation, they will be divided into 2 groups. First group including 30 patients prescribed with topical cream made of Oak extract in combination with Sina Emfolish topical ointment or at the discretion of the physician with additional glucantime. The second group receive common treatments for leishmaniasis as of topical ointment of Sina Emfolish, and at the discretion with additional glucantime. Procedure started by taking smear from wounded skin area for direct and molecular smear tests. Then treatments continue with twice daily usage of topical ointment. After two months, once again smear will be taken from wounded area. Meanwhile dermatologist survey clinical status of the wound and report every case condition. Second group treatment duration is in accordance with remedy protocols and dermatologist discretion, Blinding description: volunteer participants will only keep blind in this trial. N/A Leishmaniasis. Intervention 1: Intervention group: cases under treatment with Oak ointment. Ingredients: Oak ointment, Density of 8g in 100 dosage of use. Consumption: Once a day with refreshing bondage. Number of usage: 20 times. Period: 20 days. Method: Topical. Manufacturer: Zojaj Daru. Intervention 2: Control group: group treated with common drug. Consumption: Glucantime ampoule or Sina ampoule ointment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Drug results will be published after laboratory and clinical verification.
public Vahid Sepehr
No. 96, Kolahdooz 8th, Kolahdooz Blvd.
Mashhad Iran (Islamic Republic of) 9183837341 +98 51 3845 9666 info@simateb.com Sima Teb Clinic scientific Mohammad Reza Khakzad
Shahin Far College, Imam Khomeini 14th, Imam Khomeini Blvd.
Mashhad Iran (Islamic Republic of) 9133683666 +98 51 3225 6291 mr.khakzad@gmail.com Faculty of Medicine, Islamic Azad University, Mashhad Branch Iran (Islamic Republic of) Patients with active leishmaniasis ulcers on a part of their body. Patients with less than 4 months of leishmaniasis develops on their skin. no limit no limit Both Patients with inactive leishmaniasis on their skin. Any drug allergy recognition by medical practitioner. B55 Leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: cases under treatment with Oak ointment. Ingredients: Oak ointment, Density of 8g in 100 dosage of use. Consumption: Once a day with refreshing bondage. Number of usage: 20 times. Period: 20 days. Method: Topical. Manufacturer: Zojaj Daru Control group: group treated with common drug. Consumption: Glucantime ampoule or Sina ampoule ointment Wounds larger than ≥ 3 cm. Timepoint: Before treatments begin and 8 weeks after it. Method of measurement: Direct blood smear and PCR test. Marham Sazan Moghan Daroo Company Approved 2020-08-05 Ethics Committee in Biomedical Research - Islamic Azad University, Mashhad Branch Faculty of Medicine, Azad University of Mashhad,14th Imam Khomeini St., 14th Imam Khomeini St., Imam Khomeini Blvd., Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)