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IRCT20221209056758N1 IRCT 2023-01-01 Babol University of Medical Sciences Gho­­rs-Gol-Mohammadi in functional dyspepsia 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 2023-02-04 anticipated 70 Complete https://irct.ir/trial/67360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Functional dyspepsia. Intervention 1: Intervention group: Intervention group: GHors-Golmohammadi tablet consisting of R. damascena petals and dried licorice and N. jatamansi rhizomes, with a dose of 500 mg, three times a day (after meals) for 4 weeks. The drug is prepared by a specialist pharmacist in the pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. In order to prepare medicine, in each plant is dried and ground into powder. Rose, licorice and jatamansi plant powders are mixed in a weight ratio of 2:1:1 and mixed with suitable excipients and natural polymers. Then, the powder is moistened and granulated for a short time by means of a certain ratio of wetting agents. After drying and disinfecting, the granules are ground again, then, tablets are pressed. The tablet is determined by the amount of gallic acid and glycyrrhizic acid, and physicochemical and microbial control tests are performed. Intervention 2: Control group: placebo. 3 times a day, for 4 weeks. Both groups are received standard treatments. The placebo is prepared by a specialist pharmacist in the pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. For the preparation of placebo, corn starch is used. In order to make its smell similar to the original medicine, it is mixed with the powder of Ghors-Gol-mohammadi at a ratio of 1%. Also, allowed and standard coloring agent is used to simulate the color of the original tablet. Each tablet contains 500 mg of powder. microbial limit tests are performed. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Nader Behgam
GanjAfrooz St
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4728 Behgam98@gmail.com Babol University of Medical Sciences scientific Zahra Memariani
GanjAfrooz St
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4728 memarianiz@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Patients with complaints of Functional dyspepsia Diagnosis of functional dyspepsia based on ROME IV criteria by gastroenterologist Helicobacter pylori infection positive test 18 years 65 years Both History of peptic ulcer or reflux disease Endoscopy with specific pathological findings The presence of underlying diseases including heart failure, high blood pressure, kidney failure and uremic disease, cirrhosis History of abdominal surgery Any type of malignancy, history of chemotherapy and radiotherapy or exposure to radioactive radiation Pregnancy and breastfeeding Helicobacter pylori infection negative test NSAIDs or any herbal medicine use Smoking and alcohol consumption History of any sensitivity to formulation components K30 Functional dyspepsia Treatment - Drugs Placebo Intervention group: Intervention group: GHors-Golmohammadi tablet consisting of R. damascena petals and dried licorice and N. jatamansi rhizomes, with a dose of 500 mg, three times a day (after meals) for 4 weeks. The drug is prepared by a specialist pharmacist in the pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. In order to prepare medicine, in each plant is dried and ground into powder. Rose, licorice and jatamansi plant powders are mixed in a weight ratio of 2:1:1 and mixed with suitable excipients and natural polymers. Then, the powder is moistened and granulated for a short time by means of a certain ratio of wetting agents. After drying and disinfecting, the granules are ground again, then, tablets are pressed. The tablet is determined by the amount of gallic acid and glycyrrhizic acid, and physicochemical and microbial control tests are performed. Control group: placebo. 3 times a day, for 4 weeks. Both groups are received standard treatments. The placebo is prepared by a specialist pharmacist in the pharmacy laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences. For the preparation of placebo, corn starch is used. In order to make its smell similar to the original medicine, it is mixed with the powder of Ghors-Gol-mohammadi at a ratio of 1%. Also, allowed and standard coloring agent is used to simulate the color of the original tablet. Each tablet contains 500 mg of powder. microbial limit tests are performed. The effect of «Ghors-Gol-mohammadi» on the severity of Functiona dyspepsia symptoms based on the total score of the GSRS questionnaire. Timepoint: At the beginning of the study, the second, fourth, sixth and eighth weeks from the beginning of the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale questionnaire. The effect of "Ghors-Gol-mohammadi" on the severity of gastrointestinal symptoms in each of the 5 subgroups of symptoms of the Gastrointestinal Symptom Rating Scale questionnaire and the symptoms related to postprandial distress syndrome. Timepoint: Before starting the intervention, the second, fourth, and eighth following weeks. Method of measurement: Gastrointestinal Symptom Rating Scale. Score of quality of life. Timepoint: before the starting the intervention and at the eighth week. Method of measurement: Persian Nepean Quality of Life Questionnaire (NDI-10). Helicobacter pylori infection. Timepoint: Before the starting of the study and at the sixth week. Method of measurement: Urea breath test. Babol University of Medical Sciences Approved 2022-11-27 Research Ethics Committee, Health Research Institute, Babol University of Medical Sciences GanjAfrooz St; Babol University of Medical Sciences, Babol Babol Mazandaran Iran (Islamic Republic of)