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IRCT20160306026938N10 IRCT 2022-07-11 Tehran University of Medical Sciences The Effect of Ajwain fruit and Melissa extract on Improvement of Irritable Bowel Syndrome (IBS) Symptoms Evaluation of the effectiveness of capsule containing dry extract of Trachyspermum ammi and Melissa officinalis in patients with irritable bowel syndrome (a clinical trial in phase 2B) 2022-07-23 anticipated 100 Complete https://irct.ir/trial/64661 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 100 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 50 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 100, 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. 2-3 Irritable Bowel Syndrome(IBS). Intervention 1: Intervention group: Oral prescription of a 100 mg capsule containing hydroalcoholic extract of Ajwain fruit, equal to 3 g of it and 100 mg of melissa officinalis 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 40 Irritable bowel syndrome patients, three times a day (morning-noon-evening), for a one-month period. 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 40 Irritable bowel syndrome patients, three times a day (morning-noon-evening), for a one month period. 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 organisations Conditions: ny type 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) Adherence to diagnostic criteria of Irritable Bowel Syndrome (IBS) including recurrent abdominal pain at least three days in a month during past three months and beginning of symptoms at least from six months ago plus at least two conditions of three pain alleviation conditions after defecation, variations in number of defecation times and changes in stool consistency. Age range of 18-70 years old Signing the informed consent 18 years 70 years Both Being afflicted with any underlying disease pregnancy Being allergic to Apiaceae family plants Bowel dysfunctions including abnormal colonoscopy observations Lactation period Consumption of medications for improvement of irritable bowel syndrome symptoms K58 Irritable bowel syndrome 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 100 mg of melissa officinalis 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 40 Irritable bowel syndrome patients, three times a day (morning-noon-evening), for a one-month period 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 40 Irritable bowel syndrome patients, three times a day (morning-noon-evening), for a one month period. Abdominal pain. Timepoint: After intervention (one month 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 (one month 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 (one month 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 (one month 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). Quality of life score. Timepoint: Before intervention, 2 weeks after intervention, 4 weeks after study being initiated, 2 weeks after termination of the intervention. Method of measurement: Completing 34-item questionnaire of life quality among IBS patients (IBS_QOL34) by the patient himself. Tehran University of Medical Sciences Approved 2022-07-02 Research Ethichs Committees of The Institute of Pharmaceutical Sciences- Tehran University Of Medica 16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219، Tehran Tehran Iran (Islamic Republic of)