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IRCT20200303046677N5 IRCT 2021-01-16 Shahid Beheshti University of Medical Sciences Effect of traditional medicine product based on Rosa damascena on gastroesophageal reflux disease (GERD) Effect of traditional medicine product based on Rosa damascena on gastroesophageal reflux disease (GERD): a double-blind clinical trial 2021-02-19 anticipated 70 Complete https://irct.ir/trial/51975 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomization table was created with the Excel software rand option. It was already clear that the process of reading random numbers was from top to bottom. Therefore, 35 random codes were assigned to the drug group and written on the drug, and the next 35 codes were written on the placebo, and the codes were kept confidential for use at the time of conclusion. The drugs were packed in the same containers, coded, and given to the researcher and the physician in an identical. Patients randomly received one of the containers of medication or placebo. Randomization unit: individual Randomization tool: Random number table, Blinding description: Randomization is done by Excel software and by a researcher who has no involvement in the study. The codes are then written on the same container of medicine and placebo and will be kept confidentially in an envelope until the end of the study. The prescribing physician, assistant, And the patient will not be aware of the capsules' contents until the end of the study (double-blind). 3 gastroesophageal reflux. Intervention 1: Control group: Placebo, this capsule is prepared in Tuba Green Gold Pharmaceutical Company and medicinal corn starch is used as a placebo, which is filled in capsules of the same color and size of the drug and packed in similar containers. Patients take one capsule 3 times a day after each meal for 4 weeks. Intervention 2: Intervention group: Rose capsule, this capsule is prepared in Tuba Green Gold Pharmaceutical Company. It contains 10 units of rose (petals), 2 units of licorice (dry extract), valerian (root) and 1 part of turpentine (gum) each. The drug components are ground and filled in 500 mg capsules. Quality control of product components, microbial and fungal tests of components and the final product are performed based on valid pharmacopoeias. Patients take one rose capsule 3 times a day after each meal for 4 weeks. 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
Valiasr
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rchoopani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) With reflux at the age of 18 to 80 years 18 years 80 years Both Having a history of Barrett's esophagus History of esophageal or gastric surgery History of esophageal, gastric or abdominal cancer Having coagulation problems that prevent them from stopping their medication Patients receiving regular glucocorticoids and nonsteroidal anti-inflammatory drugs more than three days a week for the past 28 days Receiving sucralfate three days before enrollment Take aspirin daily at a dose of more than 150 mg Acute peptic ulcer or its complications Receive antibiotic treatment to eradicate Helicobacter Pylori in the last 28 days Smoking or Alcohol K21 Gastro-esophageal reflux disease Placebo Treatment - Drugs Control group: Placebo, this capsule is prepared in Tuba Green Gold Pharmaceutical Company and medicinal corn starch is used as a placebo, which is filled in capsules of the same color and size of the drug and packed in similar containers. Patients take one capsule 3 times a day after each meal for 4 weeks. Intervention group: Rose capsule, this capsule is prepared in Tuba Green Gold Pharmaceutical Company. It contains 10 units of rose (petals), 2 units of licorice (dry extract), valerian (root) and 1 part of turpentine (gum) each. The drug components are ground and filled in 500 mg capsules. Quality control of product components, microbial and fungal tests of components and the final product are performed based on valid pharmacopoeias. Patients take one rose capsule 3 times a day after each meal for 4 weeks. Heartburn. Timepoint: On arrival, the second week and fourth week. Method of measurement: Questionnaire. Reflux throat. Timepoint: On arrival, the second week and fourth week. Method of measurement: Questionnaire. Pain in the middle and upper stomach. Timepoint: On arrival, the second week and fourth week. Method of measurement: Questionnaire. Nausea. Timepoint: On arrival, the second week and fourth week. Method of measurement: Questionnaire. Difficulty in falling asleep due to reflux symptoms. Timepoint: On arrival, the second week and fourth week. Method of measurement: Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-10-11 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 , Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)