The effect of Elaeagnus angustifolia cream on hemorrhoid symptoms in pregnant women

Evaluation of the effect of Elaeagnus angustifolia cram on hemorrhoid symptoms in pregnant women

Clinical trial with control group, parallel group, triple blind, randomized, phase3, on 100 pregnant women, use www.sealedenvelope.com for randomization.

This study will be conducted on 100 eligible pregnant women attending at Health Center No.1 in Mashhad. Participants will be randomly allocated to two group using a randomized block design. An independent pharmacist will be responsible for coding and the researcher, participants and statistician will remain blinded. Participants will be evaluated for symptoms at baseline,1 week and 2 weeks after the intervention.

Inclusion criteria: Able to read and write, Pregnancy women aged 18-45 years, Singleton pregnancy, Gestational age between14 and 34 weeks, Body mass index of less than 30, Willingness to participate in the study, Presence of grade 1 or 2 hemorrhoids; Exclusion criteria: Concurrent participation in another interventional study, History of hemorrhoid surgery in the last month, Presence of specific underlying diseases, obstetric complications, or other colorectal disorders, Allergy to Elaeagnus angustifolia, Use of anti-hemorrhoid drugs or systemic steroids during the two weeks before the study

Intervention group: Participants will receive lifestyle modification education and will apply 3 gram of cream containing 5 pecent hydroalcoholic extract of Elaeagnus angustifolia fruit topically every 12 hours for 2 weeks. Placebo group: Participants will receive lifestyle modification education and will apply 3 gram of base cream (without the extract) topically every 12 hours for 2 weeks.

Severity of hemorrhoid symptoms including pain, itching, swelling, bleeding, discomfort and the negative impact of hemorrhoids on wellbeing.

Participants will be randomly allocated to two groups using a randomized block design. The blockrand package will be employed through the website www.sealedenvelope.com. In the specified function, the number of treatment groups will be set to 2 and the block size to 4. The generated allocation sequence will be random with ablock size of four, and participants will be assigned to the intervention and control groups based on this sequence.

This study is designed as a triple-blind randomized controlled trial. The researcher, participants, and statistician will be blinded to group allocation( intervention vs. control). An independent pharmacist( no involvement in sample allocation, intervention, or patient assessment) will be responsible for coding. Tubes containing the active cram and placebo will be labeled as A and B.The data provided to the statistician will be coded to ensure the group identity remains undisclosed.