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IRCT20220304054179N1 IRCT 2022-04-13 Shiraz University of Medical Sciences The efficacy of an iranian traditional herbal compound in treatment of dyspepsia Study the efficacy of an iranian traditional herbal compound in treatment of functional dyspepsia, add-on double blind randomized controlled trial 2022-03-12 anticipated 150 Complete https://irct.ir/trial/62308 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is an add-on double blind randomized controlled trial study, and only statisticians know which code is drug or placebo and the questioner and patient are blinded. randomized allocation is done using block randomization; In blocking, variables such as age and sex and routine drug use and severity of symptoms will be considered. Random Sequence generation will also be done using Randomizer software. After the patient enters, the necessary explanations about the plan are provided to him and then his consent is received in the form of consent and his registration is done, based on the variables related to blocking (such as age, sex and routine medication) He is assigned, and from the codes in that block, a code is randomly assigned to the patient and the sachet with that code is delivered to the patient, Blinding description: Participants & Questioner are blinded by the end of the project. The pharmacologist is aware of the contents of the sachets (drug or placebo). The statistician who prepares the blocks and tables of random numbers is aware of the content of the codes (drug or placebo). 3 Dyspepsia. Intervention 1: Intervention group: This group receives the drug, which contains a traditional herbal composition. the components of the product include the seeds of the anise plant and the seeds of the fennel plant and the seeds of the Trachyspermum plant and the seeds of the caraway plant, which are grinded and placed in 8-gram sachets by traditional medicine pharmacist in the drug manufacturing center located in Emam Reza Clinic. Each patient is given 28 sachets. The method of taking the medicine is one sachet in the morning before breakfast and one sachet at night at bedtime, which is consumed with half a glass of water, and the treatment period is two weeks. Intervention 2: Control group: The group that receives placebo. The placebo includes corn starch, wheat bran and barley flakes and 10% of the herbal composition of the drug (to simulate the appearance of the drug), which is prepared by a traditional medicine pharmacist in the drug manufacturing center located in Emam Reza Clinic in Shiraz and placed in 8 gram sachets. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals. When: Access period starts 6 months after the results are published. To whom: All researchers can apply for data or other study documentation. Conditions: Any use of the data, analysis or copying must be done with the permission of the researcher and with respect to his intellectual rights. Where to obtain: Soodabeh Samimi, 09177921159, samimisoodabeh@sums.ac.ir How to obtain: The review and response to the applicant will take a maximum of one month. Comments:
public Soodabeh Samimi
Zand Ave., School of Medicine, 7th Floor, Department of Iranian Traditional Medicine
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶ - ۷۱۳۴۸ ۳۲۳۴۵۱۴۵-۰۷۱ samimisoodabeh@sums.ac.ir Shiraz University of Medical Sciences scientific Majid Nimroozi
Zand Ave.
Shiraz Iran (Islamic Republic of) ۱۴۳۳۶ - ۷۱۳۴۸ ۳۲۳۴۵۱۴۵-۰۷۱ mnimruzi@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 years old Men and women Patients with one of the symptoms of ROME4 dyspepsia. 18 years 65 years Both Dyspepsia with organic causes Pregnant women, having plan to conceive through the study duration Lactating women Positive history of chronic liver diseases, renal diseases, diabetes and malignancies Taking anticoagulants including warfarin, Plavix, aspirin and other chemical agents, and herbal remedies that may be considered as confounding factors for this study. Positive history of allergic reaction to "Anise", "Fennel", "Trachyspermum", "Caraway" and "Placebo composition"(Corn and wheat and barley). K30 Functional dyspepsia Treatment - Drugs Treatment - Drugs Intervention group: This group receives the drug, which contains a traditional herbal composition. the components of the product include the seeds of the anise plant and the seeds of the fennel plant and the seeds of the Trachyspermum plant and the seeds of the caraway plant, which are grinded and placed in 8-gram sachets by traditional medicine pharmacist in the drug manufacturing center located in Emam Reza Clinic. Each patient is given 28 sachets. The method of taking the medicine is one sachet in the morning before breakfast and one sachet at night at bedtime, which is consumed with half a glass of water, and the treatment period is two weeks. Control group: The group that receives placebo. The placebo includes corn starch, wheat bran and barley flakes and 10% of the herbal composition of the drug (to simulate the appearance of the drug), which is prepared by a traditional medicine pharmacist in the drug manufacturing center located in Emam Reza Clinic in Shiraz and placed in 8 gram sachets. Postprandial fullness. Timepoint: 2 weeks. Method of measurement: Gastrointestinal Symptoms Severity Questionnaire. Epigastric pain&burning sensation. Timepoint: 2 weeks. Method of measurement: Gastrointestinal Symptoms Severity Questionnaire. Shiraz University of Medical Sciences Approved 2022-01-17 Research Ethics Committee of Shiraz University of Medical Sciences Zand Ave. Shiraz Fars Iran (Islamic Republic of)