Comparison of the Effect of Herbal Laxative (Goleghand) and PEG Syrup in Functional Constipation on children referred to medical centers of Fasa University of Medical Sciences( A single-blind randomized Controlled clinical trial study)

Determining and comparing the effect of Golqand herbal laxative and PEG Dribost syrup on children's performance

A clinical trial with the control group, with parallel groups, single-blind, randomized, phase 2 on 96 patients. A randomized block was used for randomization.

The current study is a single-blind randomized clinical trial that is conducted in the medical centers of Fasa University of Medical Sciences. The research population includes children from 2 to 15 years old with constipation. 96 children are divided into groups in a blind manner. In case of any problem such as diarrhea, parents should inform the attending physician and they will be allowed to reduce the amount of PEG and Goleghand to ⅔ of the initial dose. If signs of fecal impaction are observed, additional laxatives such as paraffin will be administered at the rate of 1 to 3 cc/kg. Also, the form "satisfaction with the drug", Bristol consistency and side effects will be filled. At the end of the study (end of 8 weeks), all children are visited and forms are collected

Inclusion criteria 1. Children aged 2-15 years with constipation that has non-organic causes based on Rome IV criteria Exclusion criteria 1- Unwillingness to continue studying 2. Receiving treatment for constipation within 2 weeks before entering the study

Group (group A): PEG 4000 in the form of syrup with a dose of 0.7 g/kg twice a day Group (group B): Goleghand Barij Majun with a dose of 0.5 g/kg once a day, in the morning fasting Group (group C): Goleghand Barij Majun with a dose of 0.5 g/kg three times a day Group (group D): control group of usual treatments

Examining stool shape using the Bristol scale to determine the effect of drugs, evaluating and comparing satisfaction with drugs, evaluating and comparing side effects of drugs

The required samples will be selected from the patients referred to the pediatric department of Hazrat Wali Asr Fasa Hospital using the available method. The samples will be assigned to three study groups using the random block method of 6. In this way, 12 blocks of 6 are made as follows. The sequence of blocks is written on a card. The sequences are then enveloped and placed in a container. The participant is asked to choose one of the envelopes. The order written on the card inside the envelope determines the status of 6 participants in the groups. Then the next person chooses a block. It should be noted that the selection of envelopes is done by placement And this action will be repeated 16 times.

This study will be done as one-way blinding, so that in this study, for blinding, the researcher will divide the groups with the names A (PEG) and B (Goleghand once a day), C (Goleghand twice a day) and D (control) and the patient will not know the type of medicine assigned to him.

After the end of the study, the analyzed data can be shared in the form of articles and thesis files.

The access period starts 6 months after the results are published.

All researchers working in universities of medical sciences.

Data analysis based on statistical software

Dr Elham Kebryaei

Application submission, ethics committee approval, data submission