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IRCT20221129056657N2 IRCT 2023-01-25 Hossein Niktale - the inventor of medicine Investigating the effect of organosulfur compounds on children's lung infections The effectiveness of oral compounds derived from Organosulfur as the treatment in pediatrics with pneumonia. 2023-01-20 anticipated 70 Complete https://irct.ir/trial/67955 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual simple randomization Random number table randomization tool using www.randomization.com Allocation Concealment method: envelopes closed In this method, first, a random sequence is created, then based on the size of the research sample, a number of envelopes with aluminum wrappers (in order to avoid the clarity of the contents of the envelopes), are prepared and each of the generated random sequences is recorded on a card, and the cards are inside The letter envelopes are placed in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: For blinding, ICU nurses, ICU doctors, patient treatment physicians, laboratory experts, radiology experts, statistical consultants, and data analysts were unaware of the patient's randomization and placement in the therapy group. 3 Pneumonia. Intervention 1: Intervention group: Capsules derived from organosulfur (Nicovid capsules are ordered by Surin Salamat Sabz Tehran Company and produced by Esveh Pharmaceutical Company. Each capsule contains standardized organosulfur of garlic extract based on: Allicin, L-Cysteine, L-Methionine, Maltodextrin, and Vanilla.), containing 0.25 mg of the active ingredient, for children three to seven years old every 12 hours for 7 days and for children over 7 years old every 8 hours Duration of 7 days. Intervention 2: Control group: Administration of placebo (capsules similar to those of the intervention group with neutral implementation and maltodextrin combination) for children three to seven years old every 12 hours for 7 days and for children over 7 years old every 8 hours for 7 days. Yes - There is a plan to make this available What will be shared: Part of the data related to the main outcomes When: Six months after the results are published To whom: Academic institutions Conditions: For the purpose of research for the academic community Where to obtain: Dr. Gholamreza Khademigh Khademigh@mums.ac.ir How to obtain: The request will be sent by email to Dr. Gholamreza Khademi after correspondence about two weeks after the registration of the data request. Comments:
public Gholamreza Khademi
Akbar Children's Hospital-Shahid Kaveh Boulevard - Mashhad
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3189 1780 khademigh@mums.ac.ir Mashhad University of Medical Sciences scientific Gholamreza Khademi
Akbar Hospital, Shahid Kaveh Boulevard, Mashhad
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3871 3801 khademigh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient age 3 to 16 years The patient does not need a ventilator A patient with pneumonia and hospitalized in the special care, infectious and lung department 3 years 16 years Both History of allergy to allicin-L-cysteine History of allergy to garlic and onion Patients with a history of hypotension or gastrointestinal bleeding Low blood pressure of the patient at the beginning of the study (below 120/80) Immune compromised patients - under chemotherapy, organ and bone marrow transplantation, and patients with autoimmune diseases The patient's inability to swallow oral medication that is not embedded in the NGtube or other delivery method. J18.0 Bronchopneumonia, unspecified organism Treatment - Drugs Placebo Intervention group: Capsules derived from organosulfur (Nicovid capsules are ordered by Surin Salamat Sabz Tehran Company and produced by Esveh Pharmaceutical Company. Each capsule contains standardized organosulfur of garlic extract based on: Allicin, L-Cysteine, L-Methionine, Maltodextrin, and Vanilla.), containing 0.25 mg of the active ingredient, for children three to seven years old every 12 hours for 7 days and for children over 7 years old every 8 hours Duration of 7 days. Control group: Administration of placebo (capsules similar to those of the intervention group with neutral implementation and maltodextrin combination) for children three to seven years old every 12 hours for 7 days and for children over 7 years old every 8 hours for 7 days. Fever. Timepoint: The first day of the study before the start of the intervention and the seventh day of the study (the last day of the intervention). Method of measurement: Digital thermometer. Blood oxygen (SpO2). Timepoint: The first day of the study before the start of the intervention and the seventh day of the study (the last day of the intervention). Method of measurement: Pulse Oximeter. Erythrocyte Sedimentation Rate (ESR). Timepoint: The first day of the study before the start of the intervention and the seventh day of the study (the last day of the intervention). Method of measurement: Westergren method. Blood pressure. Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Mercury sphygmomanometer. Heart beat. Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Pulse oximeter. Blood gases. Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Blood gas measuring device. C reactive protein. Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Taking blood samples and laboratory kits. Lactate dehydrogenase. Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Electrophoresis method. D-dimer. Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Using Vidas laboratory kit. Complete blood count(CBC). Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Blood cell counting machine. Ferritin. Timepoint: At the beginning of the study (before the start of the intervention) and on the seventh day after the start of the intervention. Method of measurement: Use of ELISA laboratory kit(Enzyme-linked immuno_sorbent assay). Hossein Niktale Approved 2022-11-22 Committee on Ethics in Research, Faculty of Medicine, Mashhad University of Medical Sciences Qurashi BuildingŲŒ Daneshgah Street,Mashhad. Mashhad Razavi Khorasan Iran (Islamic Republic of)