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IRCT20190806044456N1 IRCT 2019-12-08 Ghoum University of Medical Sciences Comparison of the effects of herbal capsule Govarcin and Metoclopramide on Treatment of functional dyspepsia Comparison of the effects of herbal capsule SOE HAZEMEH (Govarcin) and Metoclopramide on the quality of life in patients with functional dyspepsia 2019-09-23 anticipated 60 Complete https://irct.ir/trial/41369 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 patients with functional dyspepsia will be randomly divided into two groups. The way to select groups is that they will be assigned to groups based on block randomization. Blocks of size 4 are considered. So we will have six blocks containing AABB, ABAB, BBAA, BABA, ABBA, BAAB. Each block will also be randomly selected using a dice throw. For example, if thrown dice is 3, the BBAA block is considered, and therefore the first two patients are assigned to treatment B and the next two patients to treatment A. The dice will be thrown ten times to complete the assignment of patients to the treatment groups, Blinding description: SOE HAZEMEH (Govarcin) is poured into the shell in powder form. Metoclopramide tablets are also poured into the shell and filled with inert filler. The two drugs are packaged in the same form.The differentiation of each drug is a number extracted from the randomization list and provided to the executor as codes A and B. 3 dyspepsia. Intervention 1: Intervention group consisted of vegetable indigestion capsule (Govarcin). This capsule contains Nigella sativa (20%), Satureja hortensis(10%), Thymus vulgaris(20%), Trachyspermum copticum(20%), Plantago major(10%), Rosa damascena (10%), Pistacia vera(10%).Dosage: Half an hour before a meal. The duration of use of this drug is four weeks. This drug is made by pharmaceutical company Booali Daroo. Its weight is 725 mg. Intervention 2: Control group: The control group consisted of metoclopramide 10 mg. Dosage: Half an hour before each meal is a single dose. It takes four weeks. This tablet is made by Oswah Pharmaceutical Company. It is a tablet that is placed in the capsule and add Microcrystalline cellulose to blind the study. 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 No more information
public Ahmad Hormati
Shahid Lavasani St. - Qom University of Medical Sciences
Qom Iran (Islamic Republic of) 3713649373 +98 25 3612 2058 hormatia113@gmail.com Ghoum University of Medical Sciences scientific Ahmad Hormati
Qom University of Medical Sciences and Health Services, Shahid Lavasani street
Qom Iran (Islamic Republic of) 3713649373 +98 25 3612 2058 hormatia113@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Patients 14 to 65 years of age with any of the symptoms of functional dyspepsia normality of upper gastrointestinal endoscopic results normal abdominal ultrasound Satisfaction with research collaboration 14 years 65 years Both Taking antipsychotic drugs Use of antidepressants Sensitivity to Metoclopramide K30 Functional dyspepsia Treatment - Drugs Treatment - Drugs Intervention group consisted of vegetable indigestion capsule (Govarcin). This capsule contains Nigella sativa (20%), Satureja hortensis(10%), Thymus vulgaris(20%), Trachyspermum copticum(20%), Plantago major(10%), Rosa damascena (10%), Pistacia vera(10%).Dosage: Half an hour before a meal. The duration of use of this drug is four weeks. This drug is made by pharmaceutical company Booali Daroo. Its weight is 725 mg. Control group: The control group consisted of metoclopramide 10 mg. Dosage: Half an hour before each meal is a single dose. It takes four weeks. This tablet is made by Oswah Pharmaceutical Company. It is a tablet that is placed in the capsule and add Microcrystalline cellulose to blind the study. Postprandial fullness. Timepoint: Before taking the drug and 4 weeks after starting medication. Method of measurement: ROM III questionnaire. Early Satiety. Timepoint: Before taking the drug and 4 weeks after starting medication. Method of measurement: ROM III questionnaire. Abdominal pain. Timepoint: Before taking the drug and 4 weeks after starting medication. Method of measurement: Determination of epigastric pain according to VAS criteria and questionnaire ROM III. Heartburn. Timepoint: Before taking the drug and 4 weeks after starting medication. Method of measurement: ROM III questionnaire. Quality of Life. Timepoint: Before taking the drug and 4 weeks after starting medication. Method of measurement: ROM III questionnaire. BooaliDaro Pharmaceutical company Approved 2019-07-30 Ethics Committee of Qom University of Medical Sciences No. 83, No. 4 Alley, 1/1 Alley, Saffashahr street Qom Ghoum Iran (Islamic Republic of)