To determine therapeutic potency of administration of Ziziphus jujuba, Ginseng, and famotidine, against post-surgical adhesion bands in patients with abdominal surgery

To determine therapeutic potency of administration of Ziziphus jujuba, Ginseng, and famotidine, against post-surgical adhesion bands in patients with abdominal surgery

This is a phase II-III clinical trial. Participants will be divided into control versus intervention group receiving Ziziphus jujuba, Ginseng, and famotidine. This is a superiority, parallel, double blinded, randomized study with 100 participants.

This is a clinical study on abdominal surgery which will be performed in Hospitals of Mashhad University of Medical Sciences. Following surgery, Ziziphus jujuba, Ginseng, and famotidine will be administered consecutively, each for 10 days. This is a double-blinded study in which both participants and data collectors will be blind to the study.

Inclusion criteria: Male or female aged 19 to 60 years who are candidate for two-stage planned operation and provide written documentation of informed consent to participate in the study. Exclusion criteria: Female patients that are pregnant or breastfeeding. Subjects suffering from intra-abdominal abscess. Participants suffering from peritoneum bacterial infection. Drug abuse patients. Participants with Previous abdominal surgery history. Subjects with type I or II Diabetes. Patients suffering from metabolic syndrome. Obese participants with BMI ≥ 30

Following abdominal surgery, Ziziphus jujuba, Ginseng, and famotidine will be administered consecutively, each for 10 days

Frequency of fibrotic adhesion bands formation post abdominal surgery

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.

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.

We will be ready to share all the collected de-identified paticipant data (IPD) to other researchers after the end of study.

Sharing of all collected de-identified participants data (IPD) will be started immediately after publication.

All collected de-identified participants data (IPD) will be shared to people working either in academic institutions or business companies upon their request.

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

Data/Documents will be obtainable by sending an e-mail to hasanianmehrm@mums.ac.ir

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.