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IRCT20221121056570N1 IRCT 2022-12-29 Ahvaz University of Medical Sciences Investigating the effect of adding traditional medicine treatments (honey and frankincense extract) to common treatments on polyuria in patients with diabetes insipidus Investigating the effect of adding traditional medicine treatments (honey and frankincense extract) to common treatments on hyperuria in patients with diabetes insipidus in the intensive care unit -a preliminary study 2023-02-20 anticipated 30 Complete https://irct.ir/trial/67310 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups is done individually. All patients who have polyuria caused by diabetes insipidus in the intensive care unit will be included in the study after obtaining written informed consent if they meet the inclusion criteria and do not have the exclusion criteria. The patient is entered into one of the intervention 1, intervention 2 or control groups according to the order of entering the department, based on the blocks (n=6) of random numbers that were previously prepared by the statistical consultant with the software. The statistician who made the random blocks did not know how to assign treatment groups (control, intervention 1 or intervention 2), Blinding description: In this study, the participants (patient and his family), nurses, principal investigator, data collectors and outcome assessors are unaware of study group allocation. Allocating the control or intervention group to the cases and drawing the drug in the syringe is done by a person who is not among the researchers or nurses taking care of the patient. 2 neurogenic diabetes insipidus due to brain diseases or head injury. Intervention 1: Intervention group 1: a group of patients who, receive traditional medicine including honey and frankincense extract as gavage every 12 hours for 48 hours in addition to classical treatments for diabetes insipidus, (10 ml of honey and 500 mg of frankincense extract dissolved in 20 ml of distilled water). Conventional treatments for diabetes insipidus include replacing the deficit of fluids with intravenous or oral solutions with minimal sodium (half saline, dextrose 5% or water) with a daily volume of approximately 4 ml per kilogram of body weight and reducing the volume of urine through the administration of Desmopressin (synthetic analogue of vasopressin) nasal spray 1-2 puff (10-40 microgram) every 12 hours and the treatment of primary brain disease. Intervention 2: Intervention group 2 : a group of patients who, receive traditional medicine every 12 hours for 48 hours including a combination of honey and ginger extract as gavage, in addition to the classical treatments for diabetes insipidus, (10 ml of honey and 500 mg of ginger extract dissolved in 20 ml of distilled water). Conventional treatments for diabetes insipidus include replacing the deficit of fluids with intravenous or oral solutions with minimal sodium (half saline, dextrose 5% or water) with a daily volume of approximately 4 ml per kilogram of body weight and reducing the volume of urine through the administration of Desmopressin (synthetic analogue of vasopressin) nasal spray 1-2 puff (10-40 microgram) every 12 hours and the treatment of primary brain disease. Intervention 3: Control group: a group of patients who only received classic treatments for diabetes insipidus, including replacement of body fluids through intravenous (half-saline fluid) and oral root at the rate of 4 ml per kilogram of body weight in 24 hours and desmopressin nasal spray (a synthetic analogue of vasopressin) under the brand of Minirin), 1 to 2 puffs (10 to 40 mg) every 12 hours. As a placebo, the patient receives a syringe containing 30 cc of water every 12 hours for 48 hours. 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 Due to the fact that sampling of patients has not been done yet, we have not made a decision to publish the data.
public Mohsen Savaie
Farvardin Street, Golestan
Ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3311 0000 drsavaie@gmail.com Ahvaz University of Medical Sciences scientific Mohsen Savaie
Esfand Street, Golestan
ahvaz Iran (Islamic Republic of) 15794 - 61357 +98 61 3311 0000 drsavaie@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Hospitalization in the intensive care unit Having diagnostic criteria for diabetes insipidus Signing the informed consent form by the patient's family Establishment of enteral nutrition Not having drug interactions with the drugs received by the patient based on the opinion of traditional medicine pharmacist colleagues 18 years no limit Both Discontinuation of enteral feeding for any reason Death of the patient due to various causes Patient discharge Declaration of non-consent by the patient's family to continue the plan The occurrence of drug interactions with the drugs received by the patient based on the opinion of traditional medicine pharmacist colleagues E23.2 Diabetes insipidus Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: a group of patients who, receive traditional medicine including honey and frankincense extract as gavage every 12 hours for 48 hours in addition to classical treatments for diabetes insipidus, (10 ml of honey and 500 mg of frankincense extract dissolved in 20 ml of distilled water). Conventional treatments for diabetes insipidus include replacing the deficit of fluids with intravenous or oral solutions with minimal sodium (half saline, dextrose 5% or water) with a daily volume of approximately 4 ml per kilogram of body weight and reducing the volume of urine through the administration of Desmopressin (synthetic analogue of vasopressin) nasal spray 1-2 puff (10-40 microgram) every 12 hours and the treatment of primary brain disease. Intervention group 2 : a group of patients who, receive traditional medicine every 12 hours for 48 hours including a combination of honey and ginger extract as gavage, in addition to the classical treatments for diabetes insipidus, (10 ml of honey and 500 mg of ginger extract dissolved in 20 ml of distilled water). Conventional treatments for diabetes insipidus include replacing the deficit of fluids with intravenous or oral solutions with minimal sodium (half saline, dextrose 5% or water) with a daily volume of approximately 4 ml per kilogram of body weight and reducing the volume of urine through the administration of Desmopressin (synthetic analogue of vasopressin) nasal spray 1-2 puff (10-40 microgram) every 12 hours and the treatment of primary brain disease. Control group: a group of patients who only received classic treatments for diabetes insipidus, including replacement of body fluids through intravenous (half-saline fluid) and oral root at the rate of 4 ml per kilogram of body weight in 24 hours and desmopressin nasal spray (a synthetic analogue of vasopressin) under the brand of Minirin), 1 to 2 puffs (10 to 40 mg) every 12 hours. As a placebo, the patient receives a syringe containing 30 cc of water every 12 hours for 48 hours. Patient's urine volume during 24-hour. Timepoint: 24-hour urine volume measurement at the beginning of the study (before the start of the intervention) and 24 and 48 and 72 hours after the administration of placebo, honey-frankincense or honey-ginger combination. Method of measurement: 24-hour urine volume measurement by graduated urine bags connected to the patient's Foley catheter daily (every 24 hours). Serum sodium level. Timepoint: Serum sodium level measurement at the beginning of the study (before the start of the intervention) and 24 and 48 and 72 hours after the administration of placebo, honey-frankincense or honey-ginger combination. Method of measurement: Laboratory measurement on blood sample by biochemistry autoanalyzer. Ahvaz University of Medical Sciences Approved 2022-10-18 Ethics Committee in Golestan Hospital Research Ahvaz, Golestan, Golestan Hospital ahvaz Khouzestan Iran (Islamic Republic of)