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IRCT20160306026938N17 IRCT 2023-08-27 Tehran University of Medical Sciences The Effect of Ajwain fruit extract on Peptic Ulcer Efficacy evaluation of a formulation containing dried hydroalcoholic extract of Trachyspermum ammi (Ajwain) fruit in patients with Helicobacter pylori-associated gastric or duodenal ulcer 2023-09-06 anticipated 84 Complete https://irct.ir/trial/64704 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be done using graphpad.com and assigning letters A or B to the treatment or placebo groups and randomly distributing 84 people to the receiving group A or B. The software randomly assigns the letter A to 42 of the 84 numbers and the letter B to the 42 numbers. The people assigned to letter A will receive the medicine containing the extract of women and group B will receive the placebo, Blinding description: In this study, only the participants were not informed about receiving either treatment/placebo capsules. Thus, the study is a single-blinded one. The subjects in this study were not either relatives or friends, thus they couldn't compare the impacts of receiving placebo/treatment. In addition, the appearance of the capsules and their containing package was exactly similar in both Intervention/control group and is not differentiated. All the study subjects received a good deal of information regarding the research plan and have been presented to them .After being randomized through the use of statistical software package, treatment/placebo has been provided for them. 2 Peptic Ulcer. Intervention 1: Intervention group: Oral prescription of a 100 mg capsule containing hydroalcoholic extract of Ajwain fruit, equal to 3 g of it and 400 mg auxiliary ingredients including lactose powder, corn starch, and talc powder and sodium lauryl sulfate, made in Pharmacognosy laboratory of Tehran's University of Medical Science, administered on 42 patients, three times a day (morning-noon-evening), for a 14 days. Intervention 2: Control group: Oral prescription of a capsule containing 400 mg of excipients of the main medicine including 350 mg lactose powder, 25 mg corn starch, 10 mg sodium lauryl sulfate and 15 mg talc powder, prepared in pharmacognosy laboratory of Tehran's University of Medical Science, administered in 42 patients, three times a day (morning-noon-evening), for a 14 days. Yes - There is a plan to make this available What will be shared: Demographic specification of patients, would be published, except their names and address. Primary outcome of the patients would be published, too. When: Data would be available 6 months after publishing the results. To whom: Data would be available for researchers in academic and scientific organisation. Conditions: Any types of usage of data is allowable, except using for manufacturing a product. Where to obtain: Sending an E. mail to mehdivazirian@gmail.com How to obtain: After receiving E. mail, data would be sent within a week. Comments:
public Mahdi Vazirian
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6412 1223 Vazirian_m@tums.ac.ir Tehran University of Medical Sciences scientific Mahdi Vazirian
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6412 1223 Vazirian_m@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age range of 18-70 years Signing the informed consent Suffering from gastric and duodenal ulcers caused by Helicobacter pylori 18 years 70 years Both Being afflicted with any underlying disease pregnancy Being allergic to Apiaceae family plants. Lactation periode Being afflicted with Irritable Bowel Syndrome and Inflammatory Bowel Disease. Have a history of arbitrary use of antibiotics for the treatment of peptic ulcers in the last 6 months. Have a history of cancer K27 Peptic ulcer, site unspecified Treatment - Drugs Placebo Intervention group: Oral prescription of a 100 mg capsule containing hydroalcoholic extract of Ajwain fruit, equal to 3 g of it and 400 mg auxiliary ingredients including lactose powder, corn starch, and talc powder and sodium lauryl sulfate, made in Pharmacognosy laboratory of Tehran's University of Medical Science, administered on 42 patients, three times a day (morning-noon-evening), for a 14 days. Control group: Oral prescription of a capsule containing 400 mg of excipients of the main medicine including 350 mg lactose powder, 25 mg corn starch, 10 mg sodium lauryl sulfate and 15 mg talc powder, prepared in pharmacognosy laboratory of Tehran's University of Medical Science, administered in 42 patients, three times a day (morning-noon-evening), for a 14 days. Abdominal pain. Timepoint: After intervention. Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms(0=no improvement; 10= complete improvement). Bloating. Timepoint: After intervention. Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms(0=no improvement; 10= complete improvement). Diarrhea. Timepoint: After intervention. Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms(0=no improvement; 10= complete improvement). Constipation. Timepoint: After intervention. Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms(0=no improvement; 10= complete improvement). Tehran University of Medical Sciences Approved 2022-07-06 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Imam Khomeini Hospital Complex، Tohid Squrre، Tehran، Iran. Tehran Tehran Iran (Islamic Republic of)