Investigating the effect of Herbal Laxative Capsule on Postoperative Constipation of patients undergoing orthopedic surgery

Determining the effect of Herbal Laxative Capsule on Postoperative Constipation of patients undergoing orthopedic surgery

A clinical trial with a control group, a randomized, and triple blinds. The sample size is 32 in the experimental group and 32 in the control group

Consumption of Herbal Laxative Capsule for one week in the experimental group and placebo capsule in the control group. The study site is Beheshti Hospital in Kashan . Patients are not aware of being in the experimental or control group.

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

Consumption of Herbal Laxative Capsule in the intervention group and taking placebo capsule in the control group

Constipation score and the appearance of stool

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.

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.

All data is sharable when unrecognizable

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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

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