Formulation development of a combined tablet of Rosa damascena, and investigating its effectiveness on the clinical symptoms of functional dyspepsia patients: a randomized. Double-blind controlled trial

Determining the effect of the combined product of Vard tablet on the clinical symptoms of patients with Functional dyspepsia

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. A computer random number table was used for randomization

Individuals referred to the Gastrointestinal Diseases Clinic of Rouhani Hospital, Babol University of Medical Sciences, who are diagnosed as functional dyspepsia with H.pylori infection by the gastroenterologist's opinion (based on Rome IV) and were introduced to the researcher and if they met the entry criteria and informed consent are included in the study. This clinical trial is conducted in a double-blind randomized manner, with two intervention groups of "Vard tablet" and "placebo" control. In each group, 35 participants are randomly assigned. Patients, health care workers, researchers and statistical analysts are not aware of the type of intervention. The code sequence is hidden, and the drug and placebo are placed in the same sealed containers

Inclusion criteria: patients aged 18 to 65 years with symptoms of indigestion, diagnosis based on ROME IV criteria by gastroenterologist, with H.pylori infection Exclusion criteria: endoscopy with pathological findings, underlying diseases, history of abdominal surgery; Any type of malignancy, history of chemotherapy and radiotherapy. Pregnancy and breastfeeding.NSAID use and any type of herbal medicine, smoking and alcohol, history of allergy to formulation components

Intervention group: Vard tablet product consisting of Vard tablet, licorice and valerian(in a ratio of 2-1-1) Placebo group: tablets prepared from corn starch mixed with 1% of Vard tablet powder

Severity of indigestion symptoms based on the total score of the GSRS questionnaire

First, patients are divided into two groups based on a computerized random number table. The statistics consultant provides a list of the order of assigning each number to two groups to the person preparing the drugs. In the labeling phase, the medicine containers are named only based on numbers. The list of numbers and groups will be given to the person who prepares the drugs to keep it confidential until the end of the study. In order to randomly allocate the two desired drugs, the quadruple drug blocking system is used at the time of drug administration for patients.

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

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