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IRCT20231008059650N1 IRCT 2023-10-31 Institute of Medical History, Islamic and Complementary Medicine Studies Evaluation of the effectiveness of a herbal product containing Rhus Coriaria L. (Sumac) and Pimpinella Anisum (Anise) in patients with Gastroesophageal Reflux compared to placebo GERD Evaluation of the effectiveness of a herbal product containing Rhus Coriaria L. (Sumac) and Pimpinella Anisum (Anise) in patients with Gastroesophageal Reflux compared to placebo: A double-blind Randomized Clinical Trial 2023-11-06 anticipated 70 Complete https://irct.ir/trial/73127 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method and in this two-group clinical trial, we will have 4 blocks. For each person who enters the study, a code is obtained from the software and it is determined which group (intervention or control) it belongs to. We use specialized random Allocation concealment, this method is such that before the allocation of the individual, the allocated group is not known, in this way, by using non-transparent envelopes sealed with a random sequence, which in In this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box. Blocking and preparation of envelopes is done by a person not involved in data sampling and analysis, in this way, the person who collects, the person who analyzes and the person who participates in the type of intervention received and what each person in They do not know about the placed group, Blinding description: Patients participating in the study and doctors or researchers do not know the type of control or intervention group. 3 Gastroesophageal Reflux. Intervention 1: Intervention group: In the medicine group, we put 3 grams of medicine (1.5 grams of brown sumac and 1.5 grams of anise) as a mixture, divided into 6 capsules of 500 mg and 2 tablets are prescribed after each meal for 4 weeks. The drug is made by professors specializing in Iranian medicine in the traditional pharmacy laboratory of the Faculty of Iranian Medicine, Iran University of Medical Sciences. Intervention 2: Control group: Toasted bread flour in 500 mg capsules is prescribed 2 times after each meal for 4 weeks. The medicine is made by professors specializing in Iranian medicine in the traditional pharmaceutical laboratory of the Faculty of Iranian Medicine, Iran University of Medical Sciences. 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 Malihe zaman Momeniha
School of Iranian Medicine, No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5515 2191 momenihamalihezaman@gmail.com Iran University of Medical Sciences scientific Somayeh Mahroozade
School of Iranian Medicine, No 847, Behesht St. South Side of Shahr Park, Vahdat-e-Islami St., Hasan Abad Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1114733311 +98 21 5515 2191 Dr.mahroozade@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patients who have gastroesophageal reflux symptoms at least once a week (Heartburn and Regurgitation) Patients who do not complication from gastroesophageal reflux disease. People who have been diagnosed with reflux disease and have not taken medicine in the last 2 weeks and want to start anti-reflux treatment again. 20 years 60 years Both Patients with regular glucocorticoid intake Pregnancy Breastfeeding The presence of signs and symptoms of danger in the patient's history, such as weight loss of more than 10% during the last three months Patients with a history of Barrett's disease History of esophageal, stomach, or intestinal cancer Patients with coagulation disorders Patients with acute peptic ulcer or its complications K20-K31 Diseases of oesophagus, stomach and duodenum Treatment - Drugs Placebo Intervention group: In the medicine group, we put 3 grams of medicine (1.5 grams of brown sumac and 1.5 grams of anise) as a mixture, divided into 6 capsules of 500 mg and 2 tablets are prescribed after each meal for 4 weeks. The drug is made by professors specializing in Iranian medicine in the traditional pharmacy laboratory of the Faculty of Iranian Medicine, Iran University of Medical Sciences. Control group: Toasted bread flour in 500 mg capsules is prescribed 2 times after each meal for 4 weeks. The medicine is made by professors specializing in Iranian medicine in the traditional pharmaceutical laboratory of the Faculty of Iranian Medicine, Iran University of Medical Sciences. Severity of heartburn based on (QOLRAD) (FSSG). Timepoint: Severity of Heartburn before the start of the intervention, 2 and 4 weeks after the start of the intervention;. Method of measurement: Severity of Heartburn based on (FSSG) frequency scale for the symptoms of GERD و (QOLRAD) Quality Of Life in Reflux and Dyspepsia. Frequency of Heartburn based on (QOLRAD) (FSSG). Timepoint: Frequency of Heartburn before the intervention, 2 and 4 weeks after the intervention;. Method of measurement: Frequency of Heartburn based on (FSSG) frequency scale for the symptoms of GERD و (QOLRAD) Quality Of Life in Reflux and Dyspepsia. Severity of Regurgitation based on (QOLRAD) (FSSG). Timepoint: Severity of Regurgitation before the start of the intervention, 2 and 4 weeks after the start of the intervention;. Method of measurement: Severity of Regurgitation based on (FSSG) frequency scale for the symptoms of GERD و (QOLRAD) Quality Of Life in Reflux and Dyspepsia. Frequency of Regurgitation based on (QOLRAD) (FSSG). Timepoint: Frequency of Regurgitation before the intervention, 2 and 4 weeks after the intervention;. Method of measurement: Frequency of Regurgitation based on (FSSG) frequency scale for the symptoms of GERD و (QOLRAD) Quality Of Life in Reflux and Dyspepsia. Stomach temperament in terms of coldness, warmth, dryness and humidity. Timepoint: Before the start of the intervention and 4 weeks after the start of the intervention. Method of measurement: Stomach temperament questionnaires. Drug side effects. Timepoint: Week 2 and 4 after the intervention. Method of measurement: Medication side effects questionnaire. Institute of Medical History, Islamic and Complementary Medicine Studies Approved 2023-10-07 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)