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IRCT20200303046677N6 IRCT 2021-02-14 Shahid Beheshti University of Medical Sciences The effect of compound honey syrup on Functional Dyspepsia The effect of compound honey syrup on Functional Dyspepsia: a randomized double-blind placebo-controlled clinical trial 2021-02-18 anticipated 60 Complete https://irct.ir/trial/52650 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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). 3 Functional Dyspepsia. Intervention 1: Intervention group: Compound honey syrup is produced by NIAK Pharmaceutical Company with the license of the Food and Drug Administration of the Ministry of Health and Medical Education, license number 0425-94-S. This syrup contains ingredients of honey, cinnamon, ginger, saffron, cardamom, kholnjan, mastaki, jozboa and basbaseh, and the instructions for making the medicine according to the manufacturer's instructions are: 1- Honey with 2 times its amount, water poured into the container and mixed. It becomes. 2- The resulting mixture is placed at a temperature of 55 to 60 ° C and under a vacuum of 50 to 70 mm Hg to find the appropriate concentration and its volume reaches two thirds of the total initial volume. 3- From the very beginning of the heat, the semi-finished medicines of ginger, cinnamon, saffron, cardamom, kholnjan, mastaki, jozboa and basbase are poured into cotton bags and hung in a container containing a mixture of water and honey for 24 hours. 4- Then the bag is taken out and the resulting material is smoothed. 5. The resulting solution is packaged in 200 cc bottles. 6- There are 2 grams of cinnamon, 2 grams of cinnamon, 2 grams of cardamom, 1 gram of ginger, 1 gram of sage, 1 gram of saffron and 1 gram of mastic, 1 gram of gooseberry and 1 gram of basil in every 100 cycles of compound honey syrup. 7- Finally, tests of physical characteristics, pH, density, viscosity, dry weight of the extract, microbial and fungal control are performed by NIAK Pharmaceutical Company on the final product. Intervention 2: Control group: Placebo syrup is also prepared by NIAC Pharmaceutical Company, which is packaged in bottles very similar to compound honey syrup. The placebo will contain water, 0.1% sodium benzoate, 0.1% saccharin and food coloring and the required amount of carboxymethylcellulose. 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 more information
public Rasool Choopani
No.8, Valiasr Ave., Shams Ali
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rchoopani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Rasool Choopani
No.8, Valiasr Ave., Shams Ali
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rchoopani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-60 years Patients with functional dyspepsia 18 years 60 years Both 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 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 type of 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) K30 Functional dyspepsia Treatment - Drugs Placebo Intervention group: Compound honey syrup is produced by NIAK Pharmaceutical Company with the license of the Food and Drug Administration of the Ministry of Health and Medical Education, license number 0425-94-S. This syrup contains ingredients of honey, cinnamon, ginger, saffron, cardamom, kholnjan, mastaki, jozboa and basbaseh, and the instructions for making the medicine according to the manufacturer's instructions are: 1- Honey with 2 times its amount, water poured into the container and mixed. It becomes. 2- The resulting mixture is placed at a temperature of 55 to 60 ° C and under a vacuum of 50 to 70 mm Hg to find the appropriate concentration and its volume reaches two thirds of the total initial volume. 3- From the very beginning of the heat, the semi-finished medicines of ginger, cinnamon, saffron, cardamom, kholnjan, mastaki, jozboa and basbase are poured into cotton bags and hung in a container containing a mixture of water and honey for 24 hours. 4- Then the bag is taken out and the resulting material is smoothed. 5. The resulting solution is packaged in 200 cc bottles. 6- There are 2 grams of cinnamon, 2 grams of cinnamon, 2 grams of cardamom, 1 gram of ginger, 1 gram of sage, 1 gram of saffron and 1 gram of mastic, 1 gram of gooseberry and 1 gram of basil in every 100 cycles of compound honey syrup. 7- Finally, tests of physical characteristics, pH, density, viscosity, dry weight of the extract, microbial and fungal control are performed by NIAK Pharmaceutical Company on the final product. Control group: Placebo syrup is also prepared by NIAC Pharmaceutical Company, which is packaged in bottles very similar to compound honey syrup. The placebo will contain water, 0.1% sodium benzoate, 0.1% saccharin and food coloring and the required amount of carboxymethylcellulose. Early satiety. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Heaviness. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Vomit. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Burning epigastric area. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Epigastric pain. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Bloat. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Burp. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Nausea. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Severity of symptoms. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Frequency of symptoms. Timepoint: At the beginning and end of two weeks and four weeks. Method of measurement: questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-09-26 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)