Evaluation of the effect of‏‎ the poly-herbal preparation, “Gho­­rs-Gol-Mohammadi”, ‎on clinical symptoms of patients with functional dyspepsia with H. pylori infection: a ‎double-blind randomized controlled trial

Determining the effect of "Gho­­rs-Gol-Mohammadi" on clinical symptoms of patients with functional dyspepsia with Helicobacter pylori

A controlled, double-blind, randomized, trial with parallel groups, phase 3, 70 patients. A computer random number table was used for randomization.

Participants referred to Gastrointestinal Diseases Clinic of Ayatollah Rouhani Hospital, Babol University of Medical Sciences, diagnosed with functional dyspepsia with Helicobacter pylori by the gastroenterologist (based on Rome IV), are introduced to researcher and if they met the inclusion criteria and informed consent are included in the study. This is a randomized double-blind clinical trial with two intervention groups of "Gors-Gol-Mohammadi pills" and "placebo" control. In each group, 35 participants are randomly allocated. Patients, health care providers, main researcher and statistical analyst are not aware of the type of intervention. The code sequence is hidden and the drug and placebo in the same dosage form are placed in the same sealed containers.

Inclusion: patients aged 18 to 65 years with symptoms of functional dyspepsia, diagnosis based on ROME IV criteria by gastroenterologist, with Helicobacter pylori infection. Exclusion: endoscopy with pathological findings, underlying diseases, history of abdominal surgery; malignancy. Pregnancy and breastfeeding. NSAIDs, herbal medicine, alcohol usage, smoking, history of allergy to formulation components

Drug: Gho­­rs-Gol-Mohammadi preparation consisting of Rosa damascena, licorice and Nardostachys jatamansi (2-1-1); placebo: tablets of corn starch mixed with 1% of Gho­­rs-Gol-Mohammadi powder

Severity of functional dyspepsia symptoms based on the total score of the GSRS questionnaire

First, based on the computerized random number table, the statistical consultant provides a list of numbers to the person preparing the drugs. After completing the drug preparation process, in the labeling stage, the containers are coded according to the series of numbers, and the list of numbers and groups is kept confidentially by the person preparing the drug until the end of the study. Permuted blocks of 4 are used to randomly allocate participants in two interventions groups, and the preparations are placed in envelopes in the order of random allocation created.

The participants, the main researcher, the health care personnel who are responsible for the care of the patients, as well as the statistical analyzer, are blinded to the allocation of the two intervention groups to the drug or placebo. In this way, they are not aware of random codes, random allocation method and product type. Both products are prepared with the same dosage form and are placed in the same completely sealed containers.