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IRCT20130911014630N11 IRCT 2023-08-30 Mazandaran University of Medical Sciences Formulation of "Aftimoon habb and homul" Based on Iranian Traditional Pharmacy, Development of Standardization Method and Evaluation of the effect of homul on improving pelvic pain, quality of life and ovarian cyst size in endometriosis patients. Evaluation of the Effects of Traditional Dosage form Called Hamol-e-Aftimone in Improving Pelvic Pain, Quality Of Life And Ovarian Cyst Size in Endometriosis Patients; A Double-Blind, Placebo-Controlled Clinical Trial 2024-02-20 anticipated 68 Complete https://irct.ir/trial/71360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation block method will be used. The number of considered blocks is 4. The list of random allocation of patients will only be at the disposal of the project methodologist. In order to hide the random allocation process, random 10-digit codes are written on the paper labels without a specific order and framework, which is the identification number of the relevant treatment and only the project methodologist will be aware of the relevant code. The labels will be stuck on the drug packages in order of the randomization list. Drug packages will be arranged in the order of the randomization list inside the box. When the doctor declares the eligibility of a patient, the methodologist will provide the patient with the package treatment plan. The person evaluating the intended outcomes is a third person who is unaware of the randomization process and the type of treatment performed, Blinding description: The drug and placebo, which have the same size, color, and smell, are provided in the same containers based on random allocation by both groups, so none of the patients were aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used. 3 Endometriosis. Intervention 1: Intervention group: Receiving Homul(Suppository) of Aftimoon. Intervention 2: Control group: Receiving Placebo. Yes - There is a plan to make this available What will be shared: Results from clinical trials When: 2 Month after publishing To whom: Allowed only with the mention of the source. Conditions: For traditional pharmacy researchers Where to obtain: Fateme Alizade 09387845915 How to obtain: Asking from the resercher Comments:
public Fateme Alizade
Num. 67, Laleh Complex, Next to MRI, Farabi Ave.
Babol Iran (Islamic Republic of) 4731719614 +98 11 3228 0252 ft.shamalizade@gmail.com Mazandaran University of Medical Sciences scientific Dr. Mohammad Azadbakht
Pharmacy College, Payambar Azam Complex, Sari, Mazandaran, Iran
Sari Iran (Islamic Republic of) 4847191971 +98 11 3354 2472 Mazadbakht@Mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Age between 20 to 45 Endometriosis patients with pelvic pain and ovarian cyst over two centimeters Absence of Müllerian anomaly, fibrosis, adenomyosis and myoma No medication except NSAIDs for endometriosis within 6 months before referral Presence of patient's consent to participate in the study 20 years 45 years Female pregnancy and lactation Sever and treatment resistant pain which candidates patient for surgary Absence of any acute and serious liver or kidney disease Absence of pap smear with intraepithelial pathological changes No history of any former or being treated malignancy N80 Endometriosis Treatment - Drugs Placebo Intervention group: Receiving Homul(Suppository) of Aftimoon Control group: Receiving Placebo Amount of pain. Timepoint: At the beginning of the study, then during the study on period days 3 times a day. Method of measurement: Visual Analog scale. Size of ovarian cyst. Timepoint: At the beginning of the study, after the first month and after the second month. Method of measurement: Trans-vaginal ultrasound. Patient quality of life. Timepoint: At the beginning of the study, after the first month and after the second month. Method of measurement: Quality of life Questionnaire EHP30. Painkiller consumption. Timepoint: At the beginning of the study, after the first month and after the second month. Method of measurement: Questionnaire. Mazandaran University of Medical Sciences Approved 2023-07-12 Ethics committee of Mazandaran University of Madical Sciences Payambar Azam University Complex, 17' Km of Farah Abad Road sari Mazandaran Iran (Islamic Republic of)