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IRCT20200516047462N5 IRCT 2022-04-12 Kashan University of Medical Sciences The effect of Chelidonium majus and hyoscyamus niger with propolis on cutaneous Leishmaniasis The effect of topical cream containing processes of Chelidonium majus and hyoscyamus niger with propolis on leishmaniasis : Randomized and double-blind clinical trial 2022-04-21 anticipated 150 Complete https://irct.ir/trial/62765 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: The sample is divided into two groups using the Terminated Block Randomization method with blocks of 4 and 6. Prescription drugs (intervention and control) are determined based on this method and a special number is assigned to them. The doctor and the patient do not know about receiving the drug or placebo. Codes have been recorded on the worm and only the epidemiologist as one of the plan's executors knows about it. In the second phase of the study, the doctor knows the type of prescription and the patients are randomly entered into the study, and the topical cream as the main drug will be compared with routine drugs. The first phase of the study is double blind and the second phase of the study is unblinded, Blinding description: Intervention and control creams (Amphotericin B cream) are completely the same in terms of shape and container size. These creams also have no differences in terms of color and are completely unrecognizable. The important point is that the patient is told, which this topical cream used for patient may be a medicine or a control medicine. In blinding, both the doctor and the patient will be blinded. N/A Cutaneous leishmaniasis. Intervention 1: Intervention group: The intervention group includes 75 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 gr of Hyoscyamus niger along with 2 gr of propolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Intervention 2: Control group: The control group includes 75 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotrypsin b is prepared and provided to the patients in the same tube as the intervention group. Yes - There is a plan to make this available What will be shared: Information about participants such as age, gender, level of education and employment will be reported. The treatment protocol and the duration of treatment process will be reported. Therapeutic results of the product and possible side effects will be reported. When: The start of the access period will be 6 months after patent presentation or 12 months after article publication. To whom: The data will be available to researchers working in academic and scientific institutes. Conditions: The data printed in the article is accessible. Where to obtain: Moderator: Morteza Kosari Email address: kosarimorteza12@gmail.com How to obtain: We will try to respond to researchers as soon as possible. Comments:
public Morteza Kosari
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 2999 kosarimorteza12@gmail.com Kashan University of Medical Sciences scientific Morteza Kosari
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 2999 kosarimortza12@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged at least 12 years of both sexes Positive leishmania smear Real time PCR 12 years 85 years Both Pregnancy and breastfeeding The number of lesions more than 10 B55.1 Cutaneous leishmaniasis Treatment - Drugs Treatment - Drugs Intervention group: The intervention group includes 75 patients with cutaneous leishmaniasis. Topical cream containing 0.5 grams of Chelidonium majus and 0.5 gr of Hyoscyamus niger along with 2 gr of propolis is used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Control group: The control group includes 75 patients with cutaneous leishmaniasis. Topical treatment with amphotericin b used for three weeks. The duration of the use of each cream will be 7 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Amphotrypsin b is prepared and provided to the patients in the same tube as the intervention group. Complete healing of the lesion. Timepoint: On arrival or day zero, 2, 4, 7, 14 and 21 days after treatment. Method of measurement: Based on measuring the diameter of the induration of the lesion using a caliper. Kashan University of Medical Sciences Approved 2022-02-09 Ethics committee of Kashan University of Medical Sciences 5th of Qotb –e Ravandi Blvd. P.O.Box: 8715981151, Kashan, IRAN. Tel: +98-31-55548883. Fax: +98-31-55548883. Kashan Isfehan Iran (Islamic Republic of)