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IRCT20220115053713N3 IRCT 2023-01-14 Mashhad University of Medical Sciences Ziziphus jujuba, Ginseng, and famotidine, against post-surgical abdominal adhesion To determine therapeutic potency of administration of Ziziphus jujuba, Ginseng, and famotidine, against post-surgical adhesion bands in patients with abdominal surgery 2023-02-04 anticipated 50 Complete https://irct.ir/trial/67871 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 . Following providing written documentation of informed consent to participate the subjects will 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: This is a double-blind clinical trial in which participants and data analyzers will be blinded to the study. It worth noting that participants are aware that they might be randomly categorized either in the treatment or control group. Principal investigator is responsible for safety of the project, assessing results, and for writing the manuscript is not blinded to final outcomes. Data collectors, Data analyzers will be blinded in this study. Data Safety and Monitoring Board are not blind to data. 2-3 Intestinal adhesions [bands] with obstruction (postprocedural) (postinfection). Intervention 1: Control group: The control group will receive routine surgery process and placebo of Ziziphus jujuba, Ginseng, and famotidine will be given to them. Time, Form, and dose of placebo is based on the intervention group, which is explained in below. Intervention 2: Intervention group: Following abdominal surgery, Ziziphus jujuba, Ginseng, and famotidine will be administered consecutively, each for 10 days. Administration dose of Ginseng, famotidine, and Ziziphus jujuba is 2 gram, 40 mg, and 30 gram respectively. Ginseng, Fmotidine, and Ziziphus jujuba will be given in capsule, tablet, and sachet, respectively. 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 immediately. Comments:
public Seyed Mahdi Hassanian Mehr
Azadi Sq.
Mashhad Iran (Islamic Republic of) 9197985174 +98 51 3800 2353 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 2353 hasanianmehrm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Male or female aged 19 to 60 years Subjects candidate for two-stage planned operation Provide written documentation of informed consent to participate in the study. 19 years 60 years Both Female patients that are pregnant or breastfeeding. Subjects suffering from intra-abdominal abscess Participants suffering from peritoneum bacterial infection Drug abuse Participants with Previous abdominal surgery history Subjects with type I-II Diabetes Patients suffering from metabolic syndrome Obese participants with BMI ≥ 30 K56.5 Intestinal adhesions [bands] with obstruction (postprocedural) (postinfection) Placebo Treatment - Drugs Control group: The control group will receive routine surgery process and placebo of Ziziphus jujuba, Ginseng, and famotidine will be given to them. Time, Form, and dose of placebo is based on the intervention group, which is explained in below. Intervention group: Following abdominal surgery, Ziziphus jujuba, Ginseng, and famotidine will be administered consecutively, each for 10 days. Administration dose of Ginseng, famotidine, and Ziziphus jujuba is 2 gram, 40 mg, and 30 gram respectively. Ginseng, Fmotidine, and Ziziphus jujuba will be given in capsule, tablet, and sachet, respectively. Comparing frequency of adhesion bands in the presence and absence of the treatment. Timepoint: Between the 1st and the 2nd surgery. Method of measurement: Based on Zuhlke scoring system. Comparing thickness of adhesion bands in the presence and absence of treatment. Timepoint: Between the 1st and the 2nd surgery. Method of measurement: Based on Zuhlke scoring system. Comparing angiogenesis of adhesion bands in the presence and absence of treatment. Timepoint: Between the 1st and the 2nd surgery. Method of measurement: Based on Zuhlke scoring system. Bowel obstruction due to adhesion band formation. Timepoint: Between the 1st and the 2nd surgery. Method of measurement: Macroscopic evaluation by surgeon. Any side effect in the intervention group. Timepoint: Between the 1st and the 2nd surgery. Method of measurement: Analyzed by lab results and clinical outcomes. Need to re-surgery. Timepoint: Within a year post-operation. Method of measurement: Clinical symptoms. Rate of mortality post-surgery. Timepoint: Within a year post-operation. Method of measurement: Surgeon evaluation. Presence of infection, abscess, and sepsis post-surgery. Timepoint: Within a year post-operation. Method of measurement: Analyzed by lab results and clinical outcomes. Mashhad University of Medical Sciences Approved 2022-09-13 Ethics committee of Medical School of Mashhad University of Medical Sciences Azadi Sq. Mashhad Razavi Khorasan Iran (Islamic Republic of)