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

Determining the effectiveness of a herbal product containing Sumac and Anise in patients with Gastroesophageal Reflux compared to placebo

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. Random Allocation software is used for randomization.

His research environment is the Colorectal Research Center of Iran University of Medical Sciences Medicine and placebo for blinding are given to patients in 500 mg capsules, so the patients participating in the study and the doctor do not know the type of control or intervention group. The medicine or placebo for each of the two groups is prescribed for 4 weeks. Then, in the 2nd and 4th week, the patient's condition is recorded by questionnaires. The sampling method is done as Balanced Block Randomization.

Inclusion criteria: Patients who have symptoms of reflux at least once a week and do not have complications in the field of reflux. 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. Exclusion criteria: Pregnancy and breastfeeding, the presence of signs and symptoms of danger.

We put 3 grams of medicine (brown sumac and anise) as a mixture in a 500 mg capsule, and 2 pills are prescribed after each meal for 4 weeks. The placebo group was prescribed 500 mg of roasted bread flour in the same way. Reflux measures based on the clinical manual of reflux in Iranian medicine will be given to all patients participating in the project.

Severity and Frequency of Heartburn, Severity and Frequency Regurgitation; Stomach temperament; Drug Complications

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.

Patients participating in the study and doctors or researchers do not know the type of control or intervention group.