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IRCT20141230020486N5 IRCT 2023-10-14 Mashhad University of Medical Sciences Effect of propolis in pain of Endometriosis The effect of propolis supplementation in reducing pain in patients with Endometriosis 2023-10-23 anticipated 40 Complete https://irct.ir/trial/71379 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is according to the block method with various block sizes. A random chain of two groups includes treatment (T) and control (C) with a ratio of 1:1 in blocks of size 4 and 6 (7 blocks of 4 and 2 blocks of 6) with the help of www.sealedenvelope.com for 40 volunteers. Also, a 4-digit personal ID is created for each volunteer. To hide the random allocation, boxes of the same shape are used for the drug and placebo, and these boxes correspond to the random sequence of T and C with the drug or placebo, the row number 1 to 40 and the ID code are recorded on it. The steps of preparation and arrangement of the random sequence are only at the disposal of the epidemiologist of the study. The number box placed is provided to the admissions officer of the applicants. When every candidate enters the study, the box corresponding to the candidate's number is provided to him, Blinding description: All the study subjects, including the patients, the attending physician, and the project manager, are unaware of the allocation of patients to groups and the medicine they receive, and only the epidemiologist (responsible for randomization and final analysis of the data) is aware of the allocation method. The epidemiologist is neither involved in the prescription nor in the evaluation of the treatment and is only responsible for maintaining the codes and providing the numbered boxes containing the drug or placebo to the attending physician. On the boxes, only rows number 1 to 40 and the ID code are recorded, and the propolis or placebo tablets inside the box are exactly the same shape, size, and color. Therefore, it is not possible to identify the drug from the placebo for the patients, the attending physician, and the project manager. After taking the drug or placebo for 4 months, the patient is evaluated in the hospital clinic by the attending physician who does not know that he has received the drug or placebo and only knows about the ID code. Finally, the attending physician gives the evaluation results to the epidemiologist based on the code. 3 Condition 1: Endometriosis of pelvic peritoneum. Condition 2: Endometriosis of rectovaginal septum and vagina. Intervention 1: Intervention group: standard treatment (progesterone drugs) along with propolis tablets 500 mg twice a day for 4 months. These tablets are made by the pharmaceutical laboratory of the Mashhad Faculty of Pharmacy and look exactly like placebo tablets. Intervention 2: Control group: standard treatment (progesterone drugs) along with placebo tablets twice a day for 4 months. These tablets are made by the pharmaceutical laboratory of the Mashhad Faculty of Pharmacy and look exactly like propolis tablets. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: Starting 6 months after publication To whom: People working in academic institutions Conditions: Mention the source Where to obtain: Dr. Lili Hafizi Email: hafizil@mums.ac.ir Phone: 09153107633 How to obtain: Reply to email within a maximum of one week Comments:
public Leili Hafizi
Ebnesina Street, Imam Reza Hospital, Gynecology Department
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3802 2608 hafizil@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Leili Hafizi
Emam Reza Sq. Ebne-sina Ave, Emam Reza hosital
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2608 hafizil@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients with a definite diagnosis of endometriosis by imaging and have pain due to endometriosis Age between 20-45 years old Use of standard progesterone hormone treatments Not using NSAID medications Not refer for infertility treatment BMI between 18.5 to 27.5 Not taking food supplements Obtaining the patient's informed consent 20 years 45 years Female Use of hormonal contraception and IUD during the last 3 months Pregnancy or breastfeeding in the last 3 months The presence of any physical and mental disease Drug sensitivity to propolis N80.3 N80.4 Endometriosis of pelvic peritoneum Endometriosis of rectovaginal septum and vagina Treatment - Drugs Placebo Intervention group: standard treatment (progesterone drugs) along with propolis tablets 500 mg twice a day for 4 months. These tablets are made by the pharmaceutical laboratory of the Mashhad Faculty of Pharmacy and look exactly like placebo tablets. Control group: standard treatment (progesterone drugs) along with placebo tablets twice a day for 4 months. These tablets are made by the pharmaceutical laboratory of the Mashhad Faculty of Pharmacy and look exactly like propolis tablets. Endometriosis pain. Timepoint: Before the intervention and 4months after the intervention. Method of measurement: Visual Analogue Scale (VAS). Mashhad University of Medical Sciences Approved 2023-05-22 Ethics committee of Mashhad University of Medical Sciences Vice Chancellor for Research and Technology, Third floor of Ghoreshi building, Next to Hoveyzeh Cinema, Daneshgah Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)