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IRCT20151020024625N18 IRCT 2023-08-22 Semnan University of Medical Sciences Effect of IMPOHelzavid herbal compound on hospitalized patients with community-acquired pneumonia Assessing of efficacy of IMPOHelzavid herbal compound on mortality of hospitalized patients with community-acquired pneumonia 2023-09-23 anticipated 60 Complete https://irct.ir/trial/72157 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random assignment to intervention and control groups is done by block randomization (four blocks) in Excel software. In this software, treatment and control groups are placed as every other one at first column. Four blocks are placed in the next column. Finally, the random numbers created by the random number generation software are placed. Then we will arrange the numbers based on the block and random numbers columns, Blinding description: The herbal combination of IMPOHelzavid and placebo are packaged in identical packages with A or B code labels and are provided to the clinical care provider for administration. The doctor, nurse, patient, those responsible for data collection and those who evaluate the outcome are unaware of the drug and placebo groups. Only the expert in charge of the formulation who did the packaging knows the contents of the packages or the code code A or B. 2 Community acquired pneumonia. Intervention 1: Intervention group: They will receive 500 mg of the IMPOHelzavid herbal compound as 2 capsules every 12 hours for up to 72 hours. IMPOHelzavid contains a mixture of medicinal plants, including Wormwood (aerial parts), Marzangu (aerial parts), Drimia (root), Licorice (root), Hedge nettle (aerial parts), Withania somnifera (root) and Dianthus (flower). Extraction, lyophilization, encapsulation and packaging have been carried out in the Medicinal Plants Research Institute affiliated to The Academic Center for Education,Culture and Research (ACECR) under the supervision of the Food and Drug Organization. Intervention 2: Control group: They will receive two capsules, containing breadcrumbs every 12 hours for 72 hours. Yes - There is a plan to make this available What will be shared: Research results are published in the form of articles. When: The article will be published about six months after the completion of the study. To whom: There is no objection or prohibition for public use of the published article. Conditions: The use of data with reference to the source is unrestricted. Where to obtain: Vice Chancellor for Research, Semnan University of Medical Sciences of direct contact with person responsible for scientific inquiries. How to obtain: To view the report of this research, after sending the request, the Vice Chancellor for Research of Semnan University of Medical Sciences will follow up and inform. Comments:
public Farhad Malek
Amin Avenue
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 farhadmalek42@yahoo.com Semnan University of Medical Sciences scientific Farhad Malek
Amin Avenue
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 farhadmalek42@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with pneumonia 40 years 80 years Both Patients admitted in ICU Patients with uncontroled diabetes, hypertension and cardiovascular, respiratory, hepatic and renal underlying diseases J18.9 Pneumonia, unspecified organism Treatment - Drugs Placebo Intervention group: They will receive 500 mg of the IMPOHelzavid herbal compound as 2 capsules every 12 hours for up to 72 hours. IMPOHelzavid contains a mixture of medicinal plants, including Wormwood (aerial parts), Marzangu (aerial parts), Drimia (root), Licorice (root), Hedge nettle (aerial parts), Withania somnifera (root) and Dianthus (flower). Extraction, lyophilization, encapsulation and packaging have been carried out in the Medicinal Plants Research Institute affiliated to The Academic Center for Education,Culture and Research (ACECR) under the supervision of the Food and Drug Organization. Control group: They will receive two capsules, containing breadcrumbs every 12 hours for 72 hours. Blood oxygen saturation. Timepoint: At beginning and daily every 6 hours up to end of the study. Method of measurement: Pulse Oximeter. Cough. Timepoint: At beginning and daily every 12 hours up to end of the study. Method of measurement: Cough evaluating questionnaire based on Visual Analog Scales. Dyspnea. Timepoint: At beginning and daily every 12 hours up to end of the study. Method of measurement: Shortness of Breath with Daily Activities questionnaire (SOBDA). Hospitalization. Timepoint: During the study. Method of measurement: Number of hospitalization day. Need to mechanical ventilation. Timepoint: During the study. Method of measurement: If mechanical ventilation is required, the patient will be excluded from the study. Mortality. Timepoint: During the study. Method of measurement: The number of expired patients. Semnan University of Medical Sciences Approved 2023-07-31 Ethics committee of Semnan University of Medical Sciences Basij Blvd. Semnan Semnan Iran (Islamic Republic of)