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IRCT20250629066297N1 IRCT 2025-08-03 Yasouj University of Medical Sciences Investigating the effect of oral capsules containing hydroalcoholic extract of Rosa damascena petals on bowel function after cesarean section Investigating the effectiveness of administering oral capsules containing hydroalcoholic extract of Rosa damascena compared to routine care on bowel function after cesarean section in women who have undergone cesarean section. 2025-06-29 anticipated 88 Complete https://irct.ir/trial/84476 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Block randomization will be used to allocate subjects to study groups. The advantages of blocked randomization are that it ensures a balance of patient numbers in each group. The groups are defined as codes A and B. Each eligible person who applies will be assigned to one of the groups. To avoid the risk of predictably assigning people to different groups, blocks of different sizes (2,4,6,8) will be created, Blinding description: In this study, to blind the study, only the statistical analyst is blind to the groups. And the participants and the researcher are not blind to the intervention performed due to the difference in the form of medication and care. Only the statistical analyst is blind. 3 Condition 1: complications of the puerperium. Condition 2: functional intestinal disorders. Intervention 1: Intervention group: Receive capsules containing hydroalcoholic extract of rose petals. Oral capsule containing rose extract: First, rose petals are prepared and approved by a herbalist.The petals are separated and then dried and ground, and then 200 grams of powder is ground. The rose petals are mixed with 76% ethanol, and after 72 hours, they are mixed and strained into a container where they are poured, and in the next step, they are dried by a rotary machine at a temperature of 46 degrees Celsius until completely dry.It was then placed in the freezer and used in the required dosage when used in capsule making. The dose of ground rosehip extract is selected based on the conversion of animal dose to human dose. According to the research of Abbaszadeh et al. (2010), a dose of 180-190 mg per rosehip flower causes laxative production, and this dose is prepared according to the research of Nayyari et al. (2016).To check for sensitivity, the first capsule is tested on the research group and allergy symptoms are checked. The mother is also asked to inform the researcher if any allergy symptoms appear after the first use.In case of allergy, the participant will be excluded from the study and the drug will not be used and a specialist will be informed to treat the allergy. After cesarean section, no patient will be given oral or rectal bowel stimulants. In both intervention and control groups, all women were cared for with the same postoperative protocols.Oral intake of clear liquids and soft foods begins eight hours after the operation. After delivery, necessary training on how to care for the stitches, personal hygiene, nutrition, physical and sexual activity, and the frequency and method of taking the capsules, time and place of follow-up visits is provided equally to both groups by the researcher through face-to-face training.Patients are then treated with capsules starting 4 hours after surgery. At 4 hours after surgery, a capsule containing 500 mg of extract is administered, and then this dose is repeated three times at one-hour intervals. Participants are asked to record symptoms, complaints, and side effects (heartburn, diarrhea, abdominal cramps, etc.) as well as the time of drug administration on a report sheet and to inform the researcher if any problems occur.The researcher provides participants with a telephone number so that they can contact the researcher in case of problems or questions. All patients were asked to record the time of the first gas and the time of the first bowel movement and to inform the researcher. Information related to the first hour of bowel sound auscultation is reviewed and recorded by the researcher every hour until the time of sound auscultation. Intervention 2: Control group: Control group: The control group will be provided with all routine care similar to the intervention group, and starting eight hours after the cesarean section, 30 cc of magnesium hydroxide syrup will be given according to the hospital routine, starting with the start of supplementary feeding, and then it will continue every eight hours until symptoms of intestinal function appear.All patients were asked to record the time of the first gas and the time of the first bowel movement and to inform the researcher. Information regarding the first hour of bowel sound auscultation was reviewed and recorded by the researcher every hour until the time of sound auscultation. Yes - There is a plan to make this available What will be shared: Total data from informed consent forms in research designs and Total data from demographic information forms and Total data from the post-cesarean section symptom register and Total data entered into SPSS software When: The data will be kept by the corresponding author for at least five years. To whom: Competent individuals, such as editors of journals publishing study data reports Conditions: Reasonable request from competent persons while maintaining confidentiality and secrecy. Where to obtain: Dr. Fatemeh Godarzi Work address, Yasuj, Beach Park, towards Imam Sajjad Hospital (AS), Shahid Zarei Educational Campus, Faculty of Medicine Email: godarzi56@yahoo.com How to obtain: Send a message to godarzi56@yahoo.com and request the type of data. After reviewing the request, if it does not conflict with the principle of confidentiality and secrecy, the data will be sent to them as a PDF file within a maximum of one week, and if requested, the analysis data file will be sent to them as the results of the analysis in SPSS. Comments:
public Nasrin Tavakoli
No. 147 Baharestan Alley, Ahangaran Street, Kaveh Boulevard
Isfahan Iran (Islamic Republic of) 8138686946 +98 31 3339 1943 Tavakoli.nasrin.2015@gmail.com Yasouj University of Medical Sciences scientific Fatemeh Goodarzi
Shahid Zarei Educational Campus,Beach Park towards Imam Sajjad (AS) Hospital,Yasuj
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3323 5153 godarzi56@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Age between 18-45 years Candidate for elective cesarean section with local spinal anesthesia Fasting for at least 8 hours before cesarean section surgery Cooperation and consent to participate in the study Signing a written informed consent form Gestational age 38 to 42 weeks Good vital signs in mother and baby (maternal vital signs within normal limits and infant signs within normal limits for the infant) 18 years 45 years Female Use of anticoagulant drugs Use of painkillers and sedatives Unusual complications during surgery Having medical or gynecological disorders, such as hypothyroidism, diabetes, or neuromuscular disorders History of irritable bowel syndrome and idiopathic constipation Diarrhea, vomiting, or bloating in the past 48 hours Patients with postoperative complications such as uterine atony Patients with intraoperative complications (severe adhesions, excessive bowel manipulation, excessive blood loss or transfusion, and damage to the bowel or bladder) Patients whose surgery lasts more than 90 minutes Those who receive heavy doses of sedation during surgery Cesarean section above four O90.8 K59.8 Other complications of the puerperium, not elsewhere classified Other specified functional intestinal disorders Diagnosis Diagnosis Intervention group: Receive capsules containing hydroalcoholic extract of rose petals. Oral capsule containing rose extract: First, rose petals are prepared and approved by a herbalist.The petals are separated and then dried and ground, and then 200 grams of powder is ground. The rose petals are mixed with 76% ethanol, and after 72 hours, they are mixed and strained into a container where they are poured, and in the next step, they are dried by a rotary machine at a temperature of 46 degrees Celsius until completely dry.It was then placed in the freezer and used in the required dosage when used in capsule making. The dose of ground rosehip extract is selected based on the conversion of animal dose to human dose. According to the research of Abbaszadeh et al. (2010), a dose of 180-190 mg per rosehip flower causes laxative production, and this dose is prepared according to the research of Nayyari et al. (2016).To check for sensitivity, the first capsule is tested on the research group and allergy symptoms are checked. The mother is also asked to inform the researcher if any allergy symptoms appear after the first use.In case of allergy, the participant will be excluded from the study and the drug will not be used and a specialist will be informed to treat the allergy. After cesarean section, no patient will be given oral or rectal bowel stimulants. In both intervention and control groups, all women were cared for with the same postoperative protocols.Oral intake of clear liquids and soft foods begins eight hours after the operation. After delivery, necessary training on how to care for the stitches, personal hygiene, nutrition, physical and sexual activity, and the frequency and method of taking the capsules, time and place of follow-up visits is provided equally to both groups by the researcher through face-to-face training.Patients are then treated with capsules starting 4 hours after surgery. At 4 hours after surgery, a capsule containing 500 mg of extract is administered, and then this dose is repeated three times at one-hour intervals. Participants are asked to record symptoms, complaints, and side effects (heartburn, diarrhea, abdominal cramps, etc.) as well as the time of drug administration on a report sheet and to inform the researcher if any problems occur.The researcher provides participants with a telephone number so that they can contact the researcher in case of problems or questions. All patients were asked to record the time of the first gas and the time of the first bowel movement and to inform the researcher. Information related to the first hour of bowel sound auscultation is reviewed and recorded by the researcher every hour until the time of sound auscultation. Control group: Control group: The control group will be provided with all routine care similar to the intervention group, and starting eight hours after the cesarean section, 30 cc of magnesium hydroxide syrup will be given according to the hospital routine, starting with the start of supplementary feeding, and then it will continue every eight hours until symptoms of intestinal function appear.All patients were asked to record the time of the first gas and the time of the first bowel movement and to inform the researcher. Information regarding the first hour of bowel sound auscultation was reviewed and recorded by the researcher every hour until the time of sound auscultation. Time interval from first bowel movement to cesarean section. Timepoint: From four hours after the cesarean section, every hour until 24 hours after the cesarean section. Method of measurement: All patients were asked to record the time of their first bowel movement and report it to the researcher or record it on the postoperative evaluation form. The interval between the first gas release and the time of cesarean section. Timepoint: From four hours after the cesarean section, every hour until 24 hours after the cesarean section. Method of measurement: All patients were asked to record the time of the first gas release and inform the researcher. Time interval from the time of first bowel sound to cesarean section. Timepoint: Information regarding the first hour of bowel sound auscultation is reviewed and recorded by the researcher every hour until the sound is auscultated. Method of measurement: Information regarding the first hour of bowel sound auscultation is reviewed and recorded by the researcher every hour until the sound is auscultated. Length of hospital stay. Timepoint: Length of hospital stay after cesarean section in hours. Method of measurement: From the time of cesarean section to discharge in hours. Yasouj University of Medical Sciences Approved 2025-06-28 Ethics Committee of Yasuj University of Medical Sciences Shahid Motahari Blvd., Yasuj University of Medical Sciences Headquarters Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)