The effect of aloolax Syrup on constipation during pregnancy in pregnant women referred to the midwifery clinic Qom city in 1399

Effect of aloolax on constipation during pregnancy in pregnant women

Clinical trial Randomized, parallel, phase 2-3 with drug and control groups with randomized groups Based on block randomization including 36 pregnant women with constipation

72 Volunteer patients referring to a clinic, with gestational age more than 14 weeks, with constipation, are selected and after obtaining informed consent randomly divided into experimental and control groups (36 people in each group). In both groups, routine training is provided in the national protocol for combating constipation, including mobility, consumption of high-fiber foods, and drinking fluids. In the case group, Aloolax syrup is also provided free of charge with written consent.Then at the end of each week the questionnaire is completed by the Patient.The duration of syrup consumption and its effect is one month.Excellent improvement is defined by a score of 21 and severe symptoms by a score of 7. Finally, the results before and after the study are compared.

Inclusion criteria: After the fourth month of pregnancy, No history of hemorrhoids and any internal disease, normal TSH, First pregnancy. Exclusion criteria: Smoking, employed.

Intervention group: Aloolax (Prunus domestica ,Sugar,Rosa damascena, Water) syrup consumption two spoons after breakfast and two spoons after dinner + national protocol routine training. Control group: only routine protocol training.

Intensity of constipation

The way to select groups is that they will be assigned to groups based on block randomization. Blocks of size 4 are considered. So we will have six blocks containing AABB, ABAB, BBAA, BABA, ABBA, BAAB. Each block will also be randomly selected using a dice throw. For example, if thrown dice is 3, the BBAA block is considered, and therefore the first two patients are assigned to treatment B and the next two patients to treatment A. The differentiation of each groups is a number extracted from the randomization list and provided to the executor as codes A and B.The dice will be thrown 20 times to complete the assignment of patients to the treatment groups.