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IRCT20200516047462N3 IRCT 2021-11-23 Kashan University of Medical Sciences The effect of Chelidonium majus and Hyoscyamus niger with Propolis on diabetic foot ulcers The effect of topical cream of Chelidonium majus and Hyoscyamus niger with Propolis on diabetic foot ulcers 2021-11-21 anticipated 88 Complete https://irct.ir/trial/59601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are divided into two groups by terminated block randomization method with blocks of 4 and 6, prescription drugs (intervention and placebo) are determined based on this method and a special number is assigned to them Physician and patient are unaware of drug or placebo receiving and there are codes that were registered on cream and only the epidemiologist informs as a plan executor, Blinding description: A cream that has an active ingredient with a cream that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the solution themselves do not differ in terms of color, and are completely indistinguishable. The important point is that the patient is told that the topical cream used for the patient may be medication or medication. Clinicians and patients will be blinded. 3 Diabetic food ulcers. Intervention 1: The intervention group is included 44 patients with diabetic foot ulcers. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 6 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. Intervention 2: The control group includes 44 patients with diabetic foot ulcers with Wegener 1, 2 and 3 and according to standard treatment receive medication along with placebo. Topical cream with no active ingredients is used for three weeks. The duration of use of each cream will be 6 days. The patient receives a maximum of 3 creams during the treatment period. 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: This access will be based on the treatment protocol in hospitalized patients and treatment results, and includes effective ingredients and how to make the privacy cream of the project implementers. 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) Patients with diabetes who take insulin and have diabetic foot ulcers and are in the age range of 18 to 85 years. Clinical judgment of the specialist physician based on receiving the product The patient's ability and its personal desire to fill out of personal consent form to enter the study 18 years 85 years Both Existence of any history of allergy to any herbal product Patients who need surgery for their wounds L97 Ulcer of lower limb, not elsewhere classified Treatment - Drugs Placebo The intervention group is included 44 patients with diabetic foot ulcers. During three weeks, topical cream containing 0.5 grams of Chelidonium majus and 0.5 grams of Hyoscyamus niger with 2 grams of Propolis is used. The duration of each cream will be 6 days and the treatment will be done once a day. The patient receives a maximum of 3 creams during the treatment period. The control group includes 44 patients with diabetic foot ulcers with Wegener 1, 2 and 3 and according to standard treatment receive medication along with placebo. Topical cream with no active ingredients is used for three weeks. The duration of use of each cream will be 6 days. The patient receives a maximum of 3 creams during the treatment period. Size and extent of wound. Timepoint: At the beginning of the study, 4 days after treatment and 7 days after treatment, 14 days after treatment, 21 days after treatment. Method of measurement: In millimeters. The infiltration of inflammatory cells, neutrophils, monocytes, synthesis and maturation of collagen, fibroblasts and keratinocytes and induction of angiogenesis. Timepoint: 21 days after treatment. Method of measurement: Tissue sample. Nuclear hypertrophy of endothelial cells, vacuoles, diabetic foot ulcer granulation and tissue fibrosis. Timepoint: Twenty one days after treatment. Method of measurement: Histology. The duration of treatment, the speed of recovery, the rate of symptoms reduction and the duration of disease recurrence. Timepoint: Twenty one days after treatment. Method of measurement: Check list. Kashan University of Medical Sciences Approved 2021-06-26 Ethics committee of Kashan University of Medical Sciences Ghotb Ravandi Blvd, Shahid Beheshti Hospital, University of Medical Sciences, Kashan, Iran. Kashan Isfehan Iran (Islamic Republic of)