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IRCT20241208063983N1 IRCT 2024-12-25 Babol University of Medical Sciences The effect of Rosa damascena combined tablet on functional dyspepsia 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 2025-01-11 anticipated 70 Complete https://irct.ir/trial/80623 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Functional dyspepsia. Intervention 1: Intervention group:combined vard tablet consisting of rose and dried rhizomes of licorice and valerian, with a dose of 500 mg, three times a day (after meals) for four 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. The powders obtained of Rose, Licorice and Valerian plants are mixed in a ratio of 2:1:1 by weight and combined with suitable excipients and natural polymers. Then, the powder is moistened and granulated for a short time using a specific ratio of wetting agents. After drying and disinfection, the granules are ground again and then the tablets are pressed. The tablet is determined by the gallic acid and glycyrrhizic acid amount, and physicochemical and microbial control tests are performed. Intervention 2: Control group:Placebo Three pills a day (after meals) for four weeks. Both groups also receive standard treatment. Preparation of the placebo in the pharmaceutical laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences is prepared by a specialist pharmacist. For the preparation of placebo, corn starch is used. In order to make its smell similar to the original drug, it is mixed with the powder of vard tablets at a ratio of 1%. Also, permitted and standard food coloring is used to simulate the color of the original tablet. Each tablet contains 500 mg of powder. Microbial contamination control tests are performed. Placebo is a normal formulation that does not contain polymer components. Because the formula of the herbal tablet, in addition to the presence of the plant extract, is also examined in terms of the release mechanism of the extract. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Behnam Danesh
Ganj Afrooz St
babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4730 beh.danesh@gmail.com Babol University of Medical Sciences scientific Zahra Memariani
Ganj Afrooz St
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4730 memarianiz@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 65 years with complaints of indigestion Diagnosis of functional dyspepsia based on IV Rome criteria by specialist digestion Positiveness of Helicobacter pylori infection 18 years 65 years Both History of peptic ulcer Endoscopic with specific pathological findings 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 exposed to radioactive radiation, Pregnancy and breastfeeding, Negative test for Helicobacter pylori infection Use of NSAIDs and any type of herbal medicine Smoking and alcohol use, History of any allergy to product components. K30 Functional dyspepsia Treatment - Drugs Placebo Intervention group:combined vard tablet consisting of rose and dried rhizomes of licorice and valerian, with a dose of 500 mg, three times a day (after meals) for four 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. The powders obtained of Rose, Licorice and Valerian plants are mixed in a ratio of 2:1:1 by weight and combined with suitable excipients and natural polymers. Then, the powder is moistened and granulated for a short time using a specific ratio of wetting agents. After drying and disinfection, the granules are ground again and then the tablets are pressed. The tablet is determined by the gallic acid and glycyrrhizic acid amount, and physicochemical and microbial control tests are performed. Control group:Placebo Three pills a day (after meals) for four weeks. Both groups also receive standard treatment. Preparation of the placebo in the pharmaceutical laboratory of the Faculty of Traditional Medicine of Babol University of Medical Sciences is prepared by a specialist pharmacist. For the preparation of placebo, corn starch is used. In order to make its smell similar to the original drug, it is mixed with the powder of vard tablets at a ratio of 1%. Also, permitted and standard food coloring is used to simulate the color of the original tablet. Each tablet contains 500 mg of powder. Microbial contamination control tests are performed. Placebo is a normal formulation that does not contain polymer components. Because the formula of the herbal tablet, in addition to the presence of the plant extract, is also examined in terms of the release mechanism of the extract. The effect of "Rosa Damascena tablet" on the severity of indigestion symptoms based on the total score of the Gastrointestinal Symptom Rating Scale (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: GSRS Questionnaire. The effect of "Rosa Damascena tablet "on the symptoms of early satiety and heart fullness from the Rome III Persian questionnaire. Timepoint: At the beginning of the study, the second, fourth, sixth and eighth weeks from the beginning of the intervention. Method of measurement: Farsi version of Rome III diagnostic questionnaire. Severity of gastrointestinal symptoms in each of the 5 subgroups of symptoms of the Gastrointestinal Symptom Rating Scale questionnaire and symptoms related to postprandial pain syndrome. Timepoint: Before the start of the intervention, the second, fourth, and eighth weeks after the start. Method of measurement: GSRS questionnaire for the severity of gastrointestinal symptoms. Sleep quality score. Timepoint: The beginning of the study, the fourth week, the eighth week. Method of measurement: Pittsburgh Sleep Quality Questionnaire (PSQI). Babol University of Medical Sciences Approved 2024-03-16 Research Ethics Committee, Health Research Institute, Babol University of Medical Sciences Ganj Afrooz St Babol Mazandaran Iran (Islamic Republic of)