Evaluation and Comparison of the Therapeutic effect of Turpentine Van Oil and Van Raw Juice (Pistacia Atlantica sub. Cordica) in patients with Peptic ulcer

Evaluation and Comparison of the Therapeutic effect of Turpentine Van oil and Van raw juice in patients with Peptic ulcer

Clinical trial with control group ,parallel groups, triple blind, randomized, phase 3, on 275 patients.Random block using Random Allocation software is used for randomization.

Among all the peptic ulcer patients referred to Towhid Hospital and Dr.Sh.Esmaili's office in Sanandaj, 275 people are randomly selected.The studied population is divided into 5 groups: 1- receiving usual treatment of peptic ulcer plus placebo 2- usual treatment plus 2 capsules of Turpentine 3- usual treatment plus 4 capsules of Turpentine 4-usual treatment plus 2 capsules of raw Van juice 5 -usual treatment plus 4 capsules of raw Van juice.(all capsules are half milliliter And consumed daily).4-drug treatment is given for 2 weeks, then PPI is continued for another six weeks. In the intervention groups, turpentine or raw van juice is added to the usual treatment within two months.During the treatment, the patient's symptom checklist is filled every week. Endoscopy is performed twice after 1 and 2 months after starting treatment.The size, depth and induration of the ulcer are recorded in all 3 endoscopies. In this study, the researcher, participants and data analyst are blinded.

patients with peptic ulcer;underlying disease, pregnancy, continuous use of NSAIDS

1-Usual peptic ulcer treatment plus placebo2- Usual peptic ulcer treatment plus two capsules of Turpentine Van daily3- Usual peptic ulcer treatment plus four capsules of turpentine van daily4-Usual peptic ulcer treatment plus two capsules of raw Van juice daily5- Usual treatment for peptic ulcer plus four capsules of raw Van juice daily(all capsules are half milliliter)

size,depth and induration of Ulcer;clinical symptoms

The samples are determined by random block method according to the following order using Random Allocation software 1- A = patients in the first group (the group receiving the usual peptic ulcer treatment plus placebo) 2-B = patients of the second group (the group receiving the usual peptic ulcer treatment plus two capsules containing half a milliliter of turpentine vane) Daily( 3- C = patients of the third group (the group receiving the usual peptic ulcer treatment plus four capsules containing half a milliliter of turpentine) daily van 4- D - patients of the fourth group (receiving the usual peptic ulcer treatment plus two capsules containing half a milliliter of raw Ven juice daily) 5- E - patients of the fifth group (receiving the usual peptic ulcer treatment plus four capsules containing half a milliliter of raw Ven juice daily) After enrolling the patients in the study and obtaining consent for randomization, the patient's information is recorded and they are given codes through which the patient can be followed up, then the randomization list is prepared in closed envelopes that cannot be displayed (doctor, is not aware of that list and order) is given to the doctor, then the patient presents the envelope to the medicine distribution place Receives the relevant medicines.

In this study, all the patients participating in the study, all the people who are responsible for collecting the data and evaluating the results over time, the attending physician, the treatment personnel, the data analysts, the clinical caregivers, were kept blind to the allocation of the study groups. The only person who does not participate in any of the above roles and also the supervisor appointed through the ethics committee of the Kurdistan University of Medical Sciences is aware of the allocation of the groups. In coordination with the Van company, placebo, van raw juice and turpentine are all three in the form of capsules. They are similar in color, shape, size and all appearance features and cannot be distinguished from each other. The packaging is also completely similar. The only difference is the letter A, B or C on the label of the containers.

According to the request for a reasonable reason, the data that is not related to the personal information of the participants and has not been published directly will be provided to the researchers.(All individual participant data is potentially shareable after de-identification. The statistical analysis plan of the informed consent form and the clinical study report will be published in full.)

3 months after the publication of study results

Researchers working in academic and scientific institutions

Any use or analysis of the data must be done in coordination with the responsible author and after his approval.

Researchers can request documents or data files by sending an email to the person responsible for the scientific responsibility of the study. The exact response time is not known. The email and details of the person responsible for answering are mentioned in detail in the previous sections.

First, the researchers send an e-mail to the person responsible for the scientific response and specify which of the data they want. The information (except for the personal information of the participants) will be available to the said person after reviewing the request through e-mail.