Evaluation of the oral formulation of pomegranate peel extract efficacy for the treatment of cystitis

Evaluating the effectiveness of oral extract of pomegranate peel in accelerating the improvement of symptoms in patients with cystitis

Clinical trial with a control group, triple-blind design, phase three, is conducted on 40 patients, and randomization is performed using the randomization site for the purpose of randomization.

In this study, 40 patients with cystitis at Dr.Tavanaee 's clinic receive 250 milligrams of pomegranate peel extract thrice daily for seven days. A control group is also included, with randomization conducted using randomization software. The study is triple-blinded, with the patient, data analyst, and researcher all being blinded.

Inclusion criteria: 1. Women aged between 18-65 years 2. Suffering from acute uncomplicated cystitis based on clinical symptoms and U/A 3. Signing a written informed consent Non-inclusion criteria: 1. Simultaneous use of phenazopyridine 2. Taking cranberry and probiotic supplements 3. History of allergy to pomegranate and its derivatives 4. Taking warfarin or cyclosporine and tacrolimus 5. History of severe constipation or hemorrhoids

The intervention group will receive a capsule containing 250 mg of pomegranate peel extract three times a day for one week, and the control group will receive a placebo capsule containing lactose three times a day with the exact instructions as the drug group.

Primary Outcome: Assessing the severity of the Symptom Score ACSS questionnaire at the study's outset and on the third, fifth, and seventh days if symptoms persist. Secondary Outcome: Examining potential side effects by the physician and pharmacy student evaluator during visits. Comparing dysuria resolution day and urination frequency between the two comparison groups based on patient self-reports.

This study will use the block randomization method to generate a sequence of random numbers. In this method, eight blocks of size 4 and 4 blocks of size two are randomly selected from the combination of letters A and B with a table of random numbers. The list of blocks of size two is 1:AB, 2:BA, and the list of blocks of size four is: 1:AABB, 2:ABBA, 3:BBAA, 4:BAAB, 5:BABA, 6:ABAB. To select blocks of size 2, 4 numbers are randomly selected from the table of random numbers. If this number is from 0 to 4, the first block is selected, and if the number is from 5 to 9, the second block is selected. To select blocks of size 4, 8 numbers between 1 and 6 are randomly selected from the table of random numbers. Then, if this number is 1, the first block of size 4, and if the chosen number is 2, the second block and so on are selected.

In this study, the method of triple blinding includes the participants themselves, the outcome assessor (including the pharmacist), and the clinical supervisor (specialist doctor). The people mentioned in this study do not know about the type of medicine, either placebo or medicinal substance. The person who prepares the study's draft (pharmacist) needs to learn the nature of the substance used.

The findings will be published in an article. Study protocol and statistical analysis will be used for article publication.

One year after the end of the study it will be published and available in databases.

The findings will be available for researchers, clinicians, and scientific centers if the funding sponsor allows.

The other researchers can use our findings in their review articles and meta analysis.

For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir

After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks.