Efficacy evaluation of a formulation containing dried hydroalcoholic extract of Trachyspermum ammi (Ajwain) fruit in patients with Helicobacter pylori-associated gastric or duodenal ulcer

The Effect of Ajwain fruit extract in improving of Symptoms among Peptic ulcer caused by Helicobacter pylori patients and Its Comparison with Control Group

Clinical trial with control and parallel groups, single-blinded, randomized, in 2-3 phases, has been conducted on 84 patients. RAND function in Excel software has been used for randomization purposes

The Clinical trial has been conducted in 2-3 phase on 84 patients with Peptic ulcer caused by Helicobacter pylori referring to gastroenterology clinic of Imam Khomeini Hospital. Signing the informed consent .At the end of treatment, the participants were required to score items on a 0-10 Likert Scale in terms of any observed improvement on the symptoms. The study is single-blinded and only the subjects have been put blind.

Age range of 18-70 years; Informed consent form; Confirmation of disease by ROME III criteria. Exclusion criteria: suffering from IBS and IBD; Having underlying diseases; Pregnancy or Breastfeeding; Allergy to product components; History of arbitrary use of antibiotics in the last 6 monthsک History of cancer.

Oral prescription of a 100 mg capsule containing hydroalcoholic extract of Ajwain fruit and 400 mg of excipients, made in Pharmacognosy laboratory, implemented on 42 Peptic ulcer caused by Helicobacter pylori patients, three times a day for 2 weeks, Control group: Oral prescription of a 400 mg capsule containing excipients of the main medicine, including lactose powder, corn starch, sodium lauryl sulfate and talc powder, made in Pharmacognosy laboratory, implemented on 42 Peptic ulcer patients, three times a day for 2 weeks.

Abdominal pain, Diarrhea, Constipation, Bloating

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.

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.

Demographic specification of patients, would be published, except their names and address. Primary outcome of the patients would be published, too.

Data would be available 6 months after publishing the results.

Data would be available for researchers in academic and scientific organisation.

Any types of usage of data is allowable, except using for manufacturing a product.

Sending an E. mail to mehdivazirian@gmail.com

After receiving E. mail, data would be sent within a week.