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IRCT20230307057648N1 IRCT 2024-01-08 Tehran University of Medical Sciences Effect of Tabashir tablet in treatment of diabetes Evaluation of the effect of traditional Persian diabetes product (Tabashir tablet) on blood glucose level in patients with type 2 diabetes: a double-blind placebo-controlled clinical trial 2024-02-20 anticipated 106 Complete https://irct.ir/trial/69390 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Diabetic patients are randomly divided into two groups "control, intervention" after examination and if they meet the criteria to enter the trial. The random block method with blocks of four will be used by using online websites for random allocation. A numerical code is defined for the random sequence, and people receive the numerical code in the same order as they enter and are placed in the corresponding group according to the block, Blinding description: Medicine and placebo are prepared with a completely similar appearance. The patient enters the plan with his consent and receiving full explanations, but he does not know whether he has received a drug or a placebo, and the doctor is not aware of whether the product he is giving to the patient is a drug or a placebo. 3 diabetes. Intervention 1: Intervention group: One 500 mg Tabashir capsule three times a day. . Formulation (in w/w) Tabashir powder 13.2, licorice root solid extract 13.2, lettuce seed 26.5, purslane seed 20, Armenian bole 2.6, rose bud powder without sepals 6.6, Coriander leaf and stem powder 6.6, acacia extract powder 2.6, gum arabic powder 2.6, white sandal solid powder 2.6, gelnar solid powder 2.6, camphor solid powder 0.6. Intervention 2: Control group: Receiving 500 mg placebo capsules containing starch. Yes - There is a plan to make this available What will be shared: Confidentiality principles will be observed in publishing patient information. The method and results section will be mentioned in full in the article that will be written from this research. When: Information will be available from the time the article is published. To whom: Method information and results are mentioned in the article and will be available to the public Conditions: The information that is not published in the article will be provided to other researchers, if necessary, while maintaining privacy and confidentiality Where to obtain: The information published in the article will be available to the public. To obtain other documents, you should contact the project manager. How to obtain: Contact with the project manager is done via email. Then, the request is reviewed by the project manager and, if necessary, by the ethics committee, so that if there is no ethical problem, it is possible to access the documents. Comments:
public Mahbubeh Bozorgi
Khalij Fars Expressway, Shahed university
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5521 4060 mahboubehbozorgi@gmail.com Shahed University scientific Mahbubeh Bozorgi
Khalij Fars Expressway, Shahed university
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5521 4060 mahboubehbozorgi@gmail.com Shahed University Iran (Islamic Republic of) Uncontrolled type 2 diabetes Age 30-65 years HbA1c greater than 7 and lower than 8.5 Under treatment with oral diabetes medications (one or more drug groups) At least one month after increasing the dose of antidiabetic medicine or prescribing a new antidiabetic medicine 30 years 65 years Both Glomerular filtration rate, lower than 60 ml per minute Serum albumin, lower than 4 g/dL SGOT and SGPT, three times higher than normal level Pregnancy and breastfeeding or intention to become pregnant Taking insulin along with oral diabetes medications E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: One 500 mg Tabashir capsule three times a day. . Formulation (in w/w) Tabashir powder 13.2, licorice root solid extract 13.2, lettuce seed 26.5, purslane seed 20, Armenian bole 2.6, rose bud powder without sepals 6.6, Coriander leaf and stem powder 6.6, acacia extract powder 2.6, gum arabic powder 2.6, white sandal solid powder 2.6, gelnar solid powder 2.6, camphor solid powder 0.6 Control group: Receiving 500 mg placebo capsules containing starch Blood sugar. Timepoint: Blood sugar measurement at the beginning of the study (before the start of the intervention) and three months after taking the Tabashir capsule. Method of measurement: Blood test. Lipid profile. Timepoint: At the beginning and end of three months of study. Method of measurement: Blood test. Valiasr traditional medicine clinic (Dr.kordafshar clinic) Approved 2022-06-15 Ethics committee of Research Institute of Endocrine and Metabolism, Tehran university of medical sci ŮŽTehran, Persian Gulf Highway (Tehran-Qom), Shahed University Tehran Tehran Iran (Islamic Republic of)