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IRCT20191017045139N1 IRCT 2022-08-02 Kashan University of Medical Sciences The Effect of Herbal Laxative Capsule on Postoperative Constipation Investigating the effect of Herbal Laxative Capsule on Postoperative Constipation of patients undergoing orthopedic surgery 2022-08-20 anticipated 62 Complete https://irct.ir/trial/65062 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to match the intervention and control groups, the random allocation method will be used, and the participants will be divided into two intervention (herbal laxative capsule) and control (placebo capsule) groups with a 1:1 allocation ratio using random block design with a block size of four. will get By assigning the letter A to the intervention group and the letter B to the control group, 6 states (ABAB, BAAB, BBAA, AABB, BABA, ABBA) are obtained, which are written on separate cards and placed inside a black bag. will be thrown Then randomly one of the cards will be taken out of the bag and the combination of letters on it will be written on a note sheet (AABBABABBBAA...) and that card will be thrown into the container again (selection by placement). Since the sample size in this study was estimated to be 64) participants, the selection will be repeated 16 times and each time the combination written on each removed sheet will be inserted in the sequence of the written order of said sheet. Then, each letter will be assigned a number from 1 to 64 in the order of the letters noted one after the other (A1A2B3B4... B92) and each letter will be placed in an envelope (same shape, same size and same color). And the number of that letter will be written on the envelope [code1=(A), code2=(A), code3=(B), code4=(B), ... code64=(B)]. Inside the envelopes, according to the letter, a combined herbal capsule or placebo will be placed. The envelopes are opened in the order in which the subjects entered the study by the research co-worker and the letter inside the envelope is recorded (the letter A means that the patient is in the intervention group and the letter B means that the patient is in the control group) and then the capsule inside the envelope is Participants will be delivered for one week's use, Blinding description: This study will be designed and conducted in a triple blinded design (Blinding include the participants, the Epidemiologist [data analyst] and the research co-worker [collaborator collecting information]; they will not know about the allocation of participants and the type of intervention applied. If a participant complains of constipation after orthopedic surgery and this person needs intervention from the doctor's point of view, this person will be referred to the research co-worker. The main researcher has allocated the participants based on the order of the codes that have been determined in advance and the envelope number (envelope code 1 = containing herbal capsules, code 2 = containing placebo capsules, … and envelope code 62 = containing herbal capsules), which should be given to the participants by the research co-worker and then recorded their information. The research co-worker does not know the type of intervention and only gathers information. 2 Postoperative Constipation. Intervention 1: Intervention group: 520 mg Herbal Laxative Capsule (containing 100 mg of Senna alexandrina powder (leaf), 100 mg of Foeniculum vulgare (seed), 100 mg of Aloe Vera L (gum), 100 mg of Carum carvi L. powder(seed) , 100 mg of Coriandrum sativum L. powder (fruit) , 14 mg of Avisel and 6 mg of magnesium stearate. Two capsules should be taken daily (the first 30 minutes before breakfast and the second 30 minutes before lunch) for one week. This capsule is made by Ghaem Daroo Pharmaceutical Company. Intervention 2: Control group: Capsules containing 500 mg of starch powder, 14 mg of Avicel and 6 mg of magnesium stearate made by Ghaem Daroo Pharmaceutical Company.Two capsules should be taken daily (the first 30 minutes before breakfast and the second 30 minutes before lunch) for one week. Those are similar in color and appearance to Herbal Laxative Capsule. Yes - There is a plan to make this available What will be shared: All data is sharable when unrecognizable When: 1400 To whom: all researcher Conditions: to related research Where to obtain: Kashan, Kashan University of Medical Sciences, Vice President of Research and Technology of Kashan University of Medical Sciences, Mr. Dr. Gholam Ali Hamidi, phone number: 03155589399, fax: 03155589338 How to obtain: Submit a written request via fax to receive documents to the Vice President of Research and Technology of Kashan University of Medical Sciences and after a maximum of one month, receive information about the research Comments:
public Mohammadreza Zarei
Kashan University of Medical Sciences, Pezeshk Blvd, Kilometer 3 Qotbe-Ravandi Road, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5510 3143 mohammad.zarei3113@yahoo.com Kashan University of Medical Sciences scientific Mohammadreza Zarei
Kashan University of Medical Sciences, Pezeshk Blvd, Kilometer 3 Qotbe-Ravandi Road, Kashan
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5510 3143 mohammad.zarei3113@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 70 years People who had a normal bowel movement the day before the operation Do not have a problem that prevents cognitive, emotional or verbal communication (ability to communicate with the researcher). Candidate for major orthopedic surgery such as hip joint replacement, hip and proximal hip fractures, etc. Willingness to participate in the study The same drug and food regimen in the two study groups 18 years 70 years Both Irregular consumption of capsules Long-term use of drugs such as Narcotic pain relievers, antidepressants, Anti-convulsants, Iron and calcium supplements, Calcium channel blockers, Ibuprofen, and diuretics. Patient discharge earlier than 3 days Having delirium after surgery Incomplete completion of the questionnaire Receiving laxatives The appearance of symptoms of allergy to medicinal plants K59.0 Constipation Treatment - Drugs Placebo Intervention group: 520 mg Herbal Laxative Capsule (containing 100 mg of Senna alexandrina powder (leaf), 100 mg of Foeniculum vulgare (seed), 100 mg of Aloe Vera L (gum), 100 mg of Carum carvi L. powder(seed) , 100 mg of Coriandrum sativum L. powder (fruit) , 14 mg of Avisel and 6 mg of magnesium stearate. Two capsules should be taken daily (the first 30 minutes before breakfast and the second 30 minutes before lunch) for one week. This capsule is made by Ghaem Daroo Pharmaceutical Company. Control group: Capsules containing 500 mg of starch powder, 14 mg of Avicel and 6 mg of magnesium stearate made by Ghaem Daroo Pharmaceutical Company.Two capsules should be taken daily (the first 30 minutes before breakfast and the second 30 minutes before lunch) for one week. Those are similar in color and appearance to Herbal Laxative Capsule. Constipation score. Timepoint: Examining the constipation score after taking the drug on the first, third, fifth, and seventh days after surgery. Method of measurement: Using the Constipation Assessment Scale [CAS]. Stool appearance. Timepoint: Examining the stool appearance after taking the drug on the first, third, fifth, and seventh days after surgery. Method of measurement: Using the Bristol Stool Scale. Kashan University of Medical Sciences Approved 2022-05-08 Research Ethics Committees of Faculty of Medicine & Faculty of Dentistry- Kashan University of Medic Kashan University of Medical Sciences, Pezeshk Blvd, Kilometer 3 Qotbe-Ravandi Road, Kashan Kashan Isfehan Iran (Islamic Republic of)