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IRCT20200128046291N1 IRCT 2020-03-09 Babol University of Medical Sciences The effect of the “Ghors-e-Vard” ‎on functional dyspepsia Evaluation of the effect of the traditional poly-herbal preparation, “Ghors-e-Vard”, ‎on clinical symptoms of patients with functional dyspepsia 2020-04-03 anticipated 70 Complete https://irct.ir/trial/45377 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by permuted block randomization. And medicines will be randomly allocated to patients in blocks with size four. Blinding will be double-blinded in the study. Patients will not be aware of their placement in the two groups and medications will be provided in identical forms for both groups. The researcher responsible for collecting baseline information and outcomes will also not be aware of the type of medication the patient is taking, Blinding description: The drug and placebo are both prepared in identical non-transparent capsules and in completely similar cans and packages and coded according to the random table. None of the participants, principal investigator, health care personnel (physicians, nurses, etc.) responsible for patient care (etc.), data collectors and statistical analysts, will not be aware of patient received package and the coding. 3 Functional dyspepsia. Intervention 1: Intervention group: 35 patients with functional dyspepsia take 30 capsules of "Ghorse- vard" 3 times a day for 30 days after a meal. For small-lab-scale preparation of Ghors-Vard, in the cleanroom of the Traditional Pharmacy Lab of the Faculty of Traditional Medicine of Babol, under laboratory conditions, each of the dried herbs are individually milled, powdered, and passed through 60 mesh sieve. Then, according to traditional medicine sources, the required weight ratio of the powders is carefully mixed together and poured into mortar. The powder is then briefly moistened and granulated and then passed through a 40 mesh sieve. After drying and disinfecting the resulting granule in microwave in three 1 minute steps, the granules are re-milled and passed through sieve 60. After microbial control tests and quantification of phenolic compounds, the powder is filled by a capsule filler in 500 mg capsules. Both drug and control groups receive the standard treatment as well. Intervention 2: Control group: 35 patients with functional dyspepsia take 30 capsules of placebo 3 times a day for 30 days after a meal. For placebo preparation, in the clean room of the Traditional Pharmacy Lab of Babol Faculty of Traditional Medicine, under laboratory conditions, corn starch is disinfected by microwave in three minute steps, then is mixed with 1% of the Ghors-Vard powder mixed until the smell is a bit similar to the Ghors-Vard product. After microbial control tests, the powder is filled by a a manual capsule filling machine in 500 mg capsules. Yes - There is a plan to make this available What will be shared: The data will be included in the thesis after being unrecognizable When: After completing the examinations, it will be fully inserted into the thesis To whom: All researchers will have access to the central library of Babol University of Medical Sciences Conditions: Once inserted in the thesis it will be applicable Where to obtain: Refer to the library of Babol University of Medical Sciences and after providing information How to obtain: Refer to the library of Babol University of Medical Sciences and after providing information Comments:
public Hossein Kerdarian
No. 47745-47176, Ghasemi st.
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9592 Hosseinkerdarian@yahoo.com Babol University of Medical Sciences scientific Zahra Memariani
No. 47745-47176 , Ghasemi st.
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9592 z.memariani@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with Functional dyspepsia Ages 18 to 65 years 18 years 65 years Both History of gastrointestinal ulcer or reflux disease with natural endoscopy with no specific pathologic findings, Underlying diseases including heart failure, hypertension, renal failure and uremic disease, cirrhosis History of abdominal surgery Any malignancy NSAIDs Use Having a history of chemotherapy and radiotherapy or exposure to radioactive radiation. Use of any other herbal medicine Pregnancy and lactation Positive urea breath test for Helicobacter pylori infection Treatment - Other Treatment - Other Intervention group: 35 patients with functional dyspepsia take 30 capsules of "Ghorse- vard" 3 times a day for 30 days after a meal. For small-lab-scale preparation of Ghors-Vard, in the cleanroom of the Traditional Pharmacy Lab of the Faculty of Traditional Medicine of Babol, under laboratory conditions, each of the dried herbs are individually milled, powdered, and passed through 60 mesh sieve. Then, according to traditional medicine sources, the required weight ratio of the powders is carefully mixed together and poured into mortar. The powder is then briefly moistened and granulated and then passed through a 40 mesh sieve. After drying and disinfecting the resulting granule in microwave in three 1 minute steps, the granules are re-milled and passed through sieve 60. After microbial control tests and quantification of phenolic compounds, the powder is filled by a capsule filler in 500 mg capsules. Both drug and control groups receive the standard treatment as well. Control group: 35 patients with functional dyspepsia take 30 capsules of placebo 3 times a day for 30 days after a meal. For placebo preparation, in the clean room of the Traditional Pharmacy Lab of Babol Faculty of Traditional Medicine, under laboratory conditions, corn starch is disinfected by microwave in three minute steps, then is mixed with 1% of the Ghors-Vard powder mixed until the smell is a bit similar to the Ghors-Vard product. After microbial control tests, the powder is filled by a a manual capsule filling machine in 500 mg capsules. Changes in clinical symptoms of functional dyspepcia. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS). Epigastric pain. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS). Heart burn. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS). Early satiety. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS). Feeling fullness after meals. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS). Nausea. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS). Burp. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS). Flatulence. Timepoint: In days 0,14,30,60. Method of measurement: Gastrointestinal Symptom Rating Scale(GSRS). Quality of Life. Timepoint: In days 0,30. Method of measurement: Quality of Life Questionnaire (SF36). Babol University of Medical Sciences Approved 2020-01-22 Ethics committee of Babol University of Medical Sciences No. 47745-47176 , Ghasemi st. Babol Mazandaran Iran (Islamic Republic of)