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IRCT20160630028717N2 IRCT 2021-07-20 Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Comparing the effect of Fennelin and Dimethicone capsule on flatulence rate after cesarean section Comparing the effect of Fennelin and Dimethicone capsule on flatulence rate after cesarean section 2021-07-23 anticipated 80 Complete https://irct.ir/trial/57069 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, by the number of sample volumes required, block randomization with 4 and 6 block sizes will be used to randomize sample in the two groups of Fennelin and Dimethicone. Allocation of samples to groups will be done by online randomization service point Sealed Envelope Ltd. For allocation concealment will be used by Sequentially-Numbered, Opaque, Sealed Envelopes (SNOSE), Blinding description: In this study, the participants and investigator, person who evaluates the outcome will not be aware of the contents of the drug boxes. the shape of the box containing the capsules(Fennelin and Dimethicone) will be in a same color and size. Each box will be consists of 4, 30 mg of Fennelin capsules or 4 , 125 mg of dimethicone capsules. These boxes will be packed and tagged A and B letters by pharmacologist. Then these boxes will be delivered to investigator and she will be classified in two groups based on inclusion criteria and block randomization. Also the end of sampling, person who analyst will be aware which of the patients have taken which one of drugs. N/A flatulence rate after cesarean. Intervention 1: Intervention group: The Fennel group receive the box which has 4, 30 mg of Fennelin soft capsule. Each one of capsule consist of Foeniculum vulgare essential oil and standardized based on 27-21 mg of Anethole that made by Barij Essence Pharmaceutical Company. Participants take one Fennelin capsule every 6 hours for 24 hours with a glass of water. Intervention 2: Control group: : The Dimethicone group receive the box which has 4, 125 mg of Dimethicone soft capsulet(D-Gas). Each one of capsule consist of activated Dimethicone that made by Zahravi Pharmaceutical Company. Participants take one Dimethicone capsule every 6 hours for 24 hours with a glass of water. Yes - There is a plan to make this available What will be shared: The results of the data and the main consequences will be shared after the study in format of knowledge translation and exchange report to the university, presentation of reports in domestic or foreign conferences and seminars and publication of article in domestic or foreign scientific-research journals. When: It is possible to access the study results after the defense and scientific confirmation of the dissertation In a 3 months period To whom: if requested, results will be available to other academic investigators and Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Conditions: The collected data is confidential and will not be disclosed to other persons without the awareness of the Vice Chancellor for Research and Technology of the relevant university Where to obtain: To receive the documentation, send the email for update manager How to obtain: After the necessary checks, the desired documentary will be sent by email within one month period Comments:
public Parvaneh Rezasoltani
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan shahrak, Shahid Dr. Beheshti Ave., Rast, Guilan,Iran
Rasht Iran (Islamic Republic of) 41469-39841 0098 1333555056 0098 1333555058 00981333552088 rezasoltani49@gmail.com Nursing and Midwifery School of Shahid Dr. Beheshti scientific roja ghobadi
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN
Rasht Iran (Islamic Republic of) 41469-39841 0098 13 33555058, 0098 13 33555056 roja.ghobadi@gmail.com Shahid Beheshti School of Nursing and Midwifery Iran (Islamic Republic of) Willingness to participate to the study and sign a written informed consent form At least ability to read and write Feeling of flatulence Having gestational age of 37-42 weeks no limit no limit Female Having contraindication of Fennelin capsule like a history of asthma, seizures, liver disease, cancer, epilepsy and allergic reaction to to celery and Fennel according to the mother's declaration and patient file information History of intestinal disease according to the mother's declaration and patient file information R14 Flatulence and related conditions Treatment - Drugs Treatment - Drugs Intervention group: The Fennel group receive the box which has 4, 30 mg of Fennelin soft capsule. Each one of capsule consist of Foeniculum vulgare essential oil and standardized based on 27-21 mg of Anethole that made by Barij Essence Pharmaceutical Company. Participants take one Fennelin capsule every 6 hours for 24 hours with a glass of water. Control group: : The Dimethicone group receive the box which has 4, 125 mg of Dimethicone soft capsulet(D-Gas). Each one of capsule consist of activated Dimethicone that made by Zahravi Pharmaceutical Company. Participants take one Dimethicone capsule every 6 hours for 24 hours with a glass of water Rate of flatulence. Timepoint: Before taking each dose of capsules, and one hour after taking them, during 24 h. Method of measurement: Visual Analogue Scale (VAS). Vice Chancellor for Research and Technology of Guilan University of Medical Sciences Approved 2021-06-30 Ethics committee of Guilan University of Medical Sciences Deputy of Research and Technology of Gilan University of Medical Sciences, in front of 17 Shahrivar Hospital, Shahid Siadati Ave., Namjoo St. Rasht Guilan Iran (Islamic Republic of)