The effect of compound honey syrup on Functional Dyspepsia: a randomized double-blind placebo-controlled clinical trial

This study aimed to determine the effect of compound honey syrup in patients with functional dyspepsia

A clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 60 patients. Randomization prepared by Excel

Patients aged 18-60 years with Functional Dyspepsia are randomly divided into two groups according to ROME III criteria referred to the gastrointestinal clinic of Imam Hossein Hospital. Patients in the drug group use compound honey syrup. In the placebo group, placebo syrup is used. In the beginning, consent forms and questionnaires on the severity and frequency of symptoms and quality of life are completed. After two weeks, patients are followed up and In the fourth week, patients are re-visited and questionnaires of severity and frequency of symptoms and quality of life are completed.

Inclusion: Patients with Functional Dyspepsia aged between 18 and 60 years. Exclusion: Pregnancy؛ Breastfeeding؛ Active urinary tract infection History of seizure؛ Concomitant use of a chemical or other herbal medicine associated with symptoms of functional indigestion؛ Any possible severe drug-related side effects؛History of a gastrointestinal ulcer or reflux disease؛ Taking anticoagulants؛Irritable bowel syndrome؛ Surgery in the esophagus and stomach, and intestines؛ Serious organ diseases such as diabetes and cardiovascular disease؛ Consumption of any drug؛ Severe mental retardation The patient's unwillingness to continue the project؛ Failure to complete the consent form؛ Warning symptoms (severe weight loss, anemia, blood in the stool, dysphagia)

Group 1: Recipient of compound honey syrup Group 2: placebo

Early satiety; Heaviness; Vomiting; Burning epigastric area; Epigastric pain; bloating; Burp; Nausea; Severity of symptoms; Frequency of symptoms.

A table of random numbers will be created by rand Excel software. Before starting, we will determined the direction of selecting random numbers (for example from top to bottom). A series of random numbers will be selected from the table, and even numbers will be assigned to the control group and odd numbers to the intervention group. The codes will be then written on drug labels and kept secretly in an envelope. Containers containing coded drugs and placebo will be provided to the physician and research assistant. Patients start receiving from the smallest number of container to enter the plan. The first patient will be entered into the research will receive the intervention related to smallest code, and the last patient will receive the biggest code. Randomization unit: individual Randomization tool: Random number table

The syrups code will be written to the drugs lable. The Prescribing physician, assistant, and patient will not be aware of syrups' content. (Double-blind).