Ameliorative effect of Ziziphus jujube, Ginseng, and punica in decreasing adhesion band formation in patients suffering from endometriosis

To study the ameliorative effect of Ziziphus jujube, Ginseng, and punica in decreasing adhesion band formation in patients suffering from endometriosis

This is a phase II-III clinical trial. Participants will be divided into control versus intervention group receiving Ziziphus jujuba, Ginseng, and Punica. This is a superiority, parallel, double blinded, randomized study with 50 participants.

This is a clinical study on endometriosis which will be performed in Hospitals of Mashhad University of Medical Sciences. In the intervention group, along with standard treatment, Ziziphus jujuba, Ginseng, and Punica will be administered consecutively, each for 7 days. This is a double-blinded study in which both participants and data collectors will be blind to the study.

Inclusion criteria: Women patient's diagnosed with endometriosis, Aged 19 to 60 years old, Exclusion criteria: 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.

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 sachet, respectively. The control group will receive placebo instead of Ziziphus jujuba, Ginseng, and punica. Color, time, Form of the placebo is similar to the intervention

Frequency of fibrotic adhesion bands formation, Pattern of menstruations cycle

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.

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.

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.