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IRCT20220115053713N4 IRCT 2023-07-16 Mashhad University of Medical Sciences To study the role of Ziziphus jujube, Ginseng, and punica in patients suffering from endometriosis Ameliorative effect of Ziziphus jujube, Ginseng, and punica in decreasing adhesion band formation in patients suffering from endometriosis 2023-09-01 anticipated 50 Complete https://irct.ir/trial/70573 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: It is a Block randomized trial in which the Random Allocation Software will be used for allocation concealment which is performed according to SNOSE (sequentially numbered, opaque, sealed envelopes) technique. Envelopes will be sealed and one of the executive member will put randomized number into pockets . Depending on the information inside the pocket, the applicant will be either in the control or the intervention group. Following providing written documentation of informed consent to participate the subjects will randomly pick up a pocket which will be divided into control or intervention group accordingly. Size of Blocks will be four in the study, Blinding description: In this clinical trial participants will be blinded to the study. Color, shape, and type of administration of the placebo is similar to the intervention, in order to provide blindness to the participants. Data collectors, Data analyzers will be blinded in this study. 2-3 Endometriosis of uterus. Intervention 1: Control group: The control group will receive placebo instead of Ziziphus jujuba, Ginseng, and punica. Color, time, Form of the placebo is similar to the intervention. Intervention 2: Intervention group: When patient is diagnosed with endometriosis, Ziziphus jujuba, Ginseng, and punica will be administered consecutively, each for 7 days. Administration dose of Ginseng, punica, and Ziziphus jujuba is 2 gram, 1 gram, and 30 gram respectively. Ginseng, punica, and Ziziphus jujuba will be given in capsule, capsule, and powder, respectively. Ginseng and Punica will be provided by the Goldaroo Company and powder of Ziziphus will be prepared by the Pharmacy School of the Mashhad University of Medical Sciences. Yes - There is a plan to make this available What will be shared: We will be ready to share all the collected de-identified paticipant data (IPD) to other researchers after the end of study. When: Sharing of all collected de-identified participants data (IPD) will be started immediately after publication. To whom: All collected de-identified participants data (IPD) will be shared to people working either in academic institutions or business companies upon their request. Conditions: The collected de-identified participants data (IPD) will be only shared to those recipients who commit themselves to use them only for patients. They also should commit themselves to share these data with other organization only after asking permission from the original source Where to obtain: Data/Documents will be obtainable by sending an e-mail to hasanianmehrm@mums.ac.ir How to obtain: The applicant who wish to have access to document/data files should send an e-mail to hasanianmehrm@mums.ac.ir commit him/herself to not to share these documents with others unless asking permission from the original source. Next, document/data will be sent to him/her by e-mail. Comments:
public Seyed Mahdi Hassanian Mehr
Azadi Sq.
Mashhad Iran (Islamic Republic of) 9197985174 +98 51 3800 2355 hasanianmehrm@mums.ac.ir Mashhad University of Medical Sciences scientific Seyed Mahdi Hassanian Mehr
Azadi Sq.
Mashhad Iran (Islamic Republic of) 9197985174 +98 51 3800 2355 hasanianmehrm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Women patient's diagnosed with endometriosis Aged 19 to 60 years Provide written documentation of informed consent to participate in the study. 18 years 49 years Female Patients that are pregnant or breastfeeding. Drug abuse Subjects with type I-II Diabetes Patients suffering from metabolic syndrome Obese participants with BMI ≥ 30 Patients suffering from cancer Subjects with blood clotting disorders N80.0 Endometriosis of uterus Placebo Treatment - Drugs Control group: The control group will receive placebo instead of Ziziphus jujuba, Ginseng, and punica. Color, time, Form of the placebo is similar to the intervention. Intervention group: When patient is diagnosed with endometriosis, Ziziphus jujuba, Ginseng, and punica will be administered consecutively, each for 7 days. Administration dose of Ginseng, punica, and Ziziphus jujuba is 2 gram, 1 gram, and 30 gram respectively. Ginseng, punica, and Ziziphus jujuba will be given in capsule, capsule, and powder, respectively. Ginseng and Punica will be provided by the Goldaroo Company and powder of Ziziphus will be prepared by the Pharmacy School of the Mashhad University of Medical Sciences. Amount of adhesion band. Timepoint: 1 to 3 months post-treatment. Method of measurement: Based on the rASRM scoring system. Pattern of menstruations cycle. Timepoint: 1 to 3 months post-treatment. Method of measurement: Analyzed by physician menstruations cycle including amenorrhea, hypomenorrhea, and dysmenorrhea. Mashhad University of Medical Sciences Approved 2023-02-04 Ethics committee of Medical School of Mashhad University of Medical Sciences Azadi Sq. Masshad Razavi Khorasan Iran (Islamic Republic of)