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IRCT20191015045124N1 IRCT 2020-02-17 Mashhad University of Medical Sciences Evaluation of viabet capsule, a herbal formulation, as an adjuvant treatment for diabetes mellitus type 2 Evaluation of viabet capsule, a herbal formulation, as an adjuvant treatment for diabetes mellitus type 2 2020-01-07 anticipated 30 Complete https://irct.ir/trial/44033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With the help of a randomization list provided by randomization.com site, patients will receive code 1 or 2 and will be included in placebo or medication group, Blinding description: The viabet and placebo formulations will be packaged by the manufacturer in identical-looking bottle and delivered to medicine specialist. Patients who meet the inclusion criteria are selected by medicine specialist to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by an medicine specialist and a pharmacy student. Data collection and analysis are performed by the pharmacy student and clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis. 3 Type 2 diabetes. Intervention 1: Intervention group: viabet 500 mg three times a day for 3 months. Intervention 2: Control group: viabet placebo three times a day for 3 months. Yes - There is a plan to make this available What will be shared: The information will be published as an article When: The article will be available through Infinite Journal To whom: Anyone who needs them can access Conditions: The data not published in this article will be provided in coordination with all project partners and research assistants of Mashhad University of Medical Sciences Where to obtain: Send an Email to Scientific Officer How to obtain: The consent of all research associates of Mashhad University of Medical Sciences should be obtained Comments:
public Omid Tanzifi Roodi
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 tasnifio9331@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Vakilabad Boulevard; Ferdowsi University; Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetes according to the 2019 ADA Guideline Only take metformin tablets BMI between 25 - 32 40 years 75 years Both Pregnancy and lactation Sensitivity to drug Taking other diabetes medications except metformin taking drugs that affect blood sugar such as glucocorticoids Other serious illnesses such as heart failure Stomach or duodenal ulcer Use of anticoagulants such as heparin E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: viabet 500 mg three times a day for 3 months Control group: viabet placebo three times a day for 3 months Fasting blood sugar. Timepoint: Starting Study; One month later; Two months later; End of study. Method of measurement: Measurement of serum level in the laboratory. Hemoglobin A1C. Timepoint: Starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Serum creatinine. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Blood Urea Nitrogen. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Aspartate aminotransferase. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Alanine aminotransferase. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Triglyceride. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Cholesterol. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Low-density lipoprotein. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. High-density lipoprotein. Timepoint: starting Study; End of study. Method of measurement: Measurement of serum level in the laboratory. Weight. Timepoint: Starting Study; One month later; Two months later; End of study. Method of measurement: by scale. Blood pressure. Timepoint: Starting Study; One month later; Two months later; End of study. Method of measurement: By manometer. Pharmaceutical Company Essential Oil Dr Soleimani Mashhad University of Medical Sciences Pharmaceutical Company Essential Oil Dr Soleimani Approved 2019-10-02 Ethics committee of Mashhad University of Medical Sciences daneshgah street; Qureshi Building mashhad Razavi Khorasan Iran (Islamic Republic of)