Protocol summary
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Study aim
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Evaluation of safety and efficacy of IMPOHelzavid herbal compound on improving the symptoms and complications of patients with community acquired pneumonia
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Design
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This double-blind, phase 2 clinical trial is performed in 80 patients with community acquired pneumonia. Patients are randomly assigned to 40 blocks of 2 patients. Each patient in the block then receives herbal or placebo capsule with code A or B. So that 40 patients are given herbal compound and 40 people are given placebo. The duration of treatment is 7 days.
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Settings and conduct
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80 eligible patients with community acquired pneumonia referred to Shahid Beheshti Hospital will be selected and randomly divided into two groups of 40 each. The patients are given by nurse any of herbal or placebo capsule package for 7 days medication with an identification code of A or B. The package identification code are recorded in the patient's medical records. The physician, nurse, patients, data collector and who evaluate the outcome are unaware of the herbal and placebo group. Only the expert in charge of packaging knows the type of groups. Patients are unaware of the type of group they are in.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients infected with community acquired pneumonia
Age 20 to 70 years old who have the ability to take oral product
Exclusion criteria: patients with severe dyspnea require mechanical ventilation or hospitalization in intensive care units, and patients with treatment-resistant hypoxemia or those with severe underlying disease and pregnant women
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Intervention groups
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Intervention group: patients in this group receive two 500 mg capsules of herbal compound two times a day. Placebo group: patients in this group receive two 500 mg capsules of placebo two times a day.
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Main outcome variables
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Blood oxygen saturation; respiratory rate and lung inflammation.
General information
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Reason for update
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Due to the decrease in the number of hospitalized patients and those infected with covid-19, as well as the effectiveness of the IMPOHelzavid herbal compound on patients with pneumonia, this compound can be investigated on this category of patients.
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Acronym
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IMPOHelzavid
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IRCT registration information
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IRCT registration number:
IRCT20080901001157N18
Registration date:
2022-03-27, 1401/01/07
Registration timing:
prospective
Last update:
2022-07-17, 1401/04/26
Update count:
1
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Registration date
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2022-03-27, 1401/01/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-07-23, 1401/05/01
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Expected recruitment end date
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2022-11-16, 1401/08/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of safety and efficacy of IMPOHelzavid herbal compound on improving the symptoms and complications of patients with community acquired pneumonia
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Public title
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ٍEffects of herbal product IMPOHelzavid on improving patients with community acquired pneumonia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients infected with community acquired pneumonia
Age 20 to 70 years old who have the ability to take oral product
Personal desire to participate in the project and the signing of a written consent
Exclusion criteria:
Patients with severe dyspnea
Patients with reduced level of consciousness or need hospitalization in intensive care units
Patients with swallowing disorders or possibility of aspiration of food or unable to take the product orally
Patients with respiratory failure require mechanical ventilation
Patients with resistant hypoxemia
Patients with organ transplantation or malignant disease treated with corticosteroids or chemotherapy
Pregnant women
Patients with uncontrolled blood pressure, uncontrolled diabetes, cardiovascular disease and underlying respiratory disease
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Age
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From 20 years old to 70 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A random number table and block randomization method is used. In this method 80 eligible patients are assigned into 40 blocks of 2 patients. Then, each of the 2 patients in the block is randomly assigned to take herbal product or placebo, so that 40 patients assigned to each group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Package for herbal product and placebo is labeled with code B or A. Other specifications on the labels are identical. Physicians, nurses, patients, data collectors and those who evaluate the outcome are unaware of the drug and placebo group. Only the expert who has done the capsules packaging is aware of the contents of the packages or what is code A or B. Patients are aware that they are either in the herbal product or placebo groups, but they are not aware of the type of group they are in it.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-07, 1400/12/16
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Ethics committee reference number
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IR.KAUMS.REC.1400.061
Health conditions studied
1
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Description of health condition studied
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community acquired pneumonia
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ICD-10 code
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J14
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ICD-10 code description
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Pneumonia due to Hemophilus influenzae
2
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Description of health condition studied
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community acquired pneumonia
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ICD-10 code
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J13
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ICD-10 code description
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Pneumonia due to Streptococcus pneumoniae
3
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Description of health condition studied
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community acquired pneumonia
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ICD-10 code
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J15
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ICD-10 code description
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Bacterial pneumonia, not elsewhere classified
4
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Description of health condition studied
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community acquired pneumonia
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ICD-10 code
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J18.9
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ICD-10 code description
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Pneumonia, unspecified organism
Primary outcomes
1
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Description
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Blood oxygen saturation
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Timepoint
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At beginning and daily every 12 hours up to end of the study
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Method of measurement
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Pulse Oximeter
2
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Description
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Shortness of breath
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Timepoint
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At beginning and daily every 12 hours up to end of the study
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Method of measurement
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Scoring questionnaire
3
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Description
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Cough
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Timepoint
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At beginning and daily every 12 hours up to end of the study
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Method of measurement
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Scoring questionnaire
Secondary outcomes
1
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Description
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Fever
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Timepoint
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At beginning and then every 12 hours up to end of the study
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Method of measurement
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Termometer
2
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Description
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ALT
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
3
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Description
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Aspartate transaminase
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
4
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Description
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Alkaline phosphatase
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
5
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Description
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Creatinine
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
6
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Description
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BUN
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
7
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Description
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ESR
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
8
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Description
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CBC
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
9
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Description
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C-reactive protein
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
10
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Description
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Alanine transaminase
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Timepoint
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At beginning and end of the study
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Method of measurement
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Intravenous blood test
11
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Description
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Mortality rate
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Timepoint
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During the study
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Method of measurement
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Number
12
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Description
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Hospitalization
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Timepoint
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During the study
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Method of measurement
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Number
Intervention groups
1
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Description
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Intervention group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the herbal compound two times a day. The herbal capsule contains a mixture of medicinal plant extract powder and is manufactured by the ACECR Institute of Medicinal Plants. The herbal capsule is given as a supplement to patients for 7 days along with standard medications.
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Category
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Treatment - Drugs
2
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Description
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Control group: patients in this group in addition to receiving standard medications, take two 500 mg capsules of the placebo two times a day. The placebo capsule contains a toasted powder is manufactured by the ACECR Institute of Medicinal Plants. The placebo capsule is given as a supplement to patients for 12 days along with standard medications.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Research results are published in the form of articles
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Research results are published in the form of articles.
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When the data will become available and for how long
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The article will be published about six months after the completion of the project.
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To whom data/document is available
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There is no objection or prohibition for public use of the published article.
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Under which criteria data/document could be used
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The use of data with reference to the source is unrestricted.
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From where data/document is obtainable
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Vice Chancellor for Research, Kashan University of Medical Sciences
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What processes are involved for a request to access data/document
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To view the report of this research, after sending the request, the Vice Chancellor for Research of Kashan University of Medical Sciences will follow up and inform.
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Comments
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