Determining the efficacy of IMPOHelzavid herbal compound on mortality rate of hospitalized patients with community acquired pneumonia.
Design
This triple-blind, phase 2 clinical trial will be conducted in 60 patients with community-acquired pneumonia. Patients are randomly assigned in 15 blocks of 4 patients. Then each patient in the block receives a herbal or placebo capsule coded A or B. In this way, 30 patients will be received a herbal combination and 30 a placebo. The duration of treatment is 3 days.
Settings and conduct
This study will be carried out in Kowsar hospital affiliated to Semnan University of Medical Sciences. The intervention group received the herbal combination of impohelzavid IMPOHelzavid herbal compound in addition to conventional treatment and the control group received placebo in addition to conventional treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with community acquired pneumonia Age 40 to 80 years of age 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 severe underlying diseases and pregnant women.
Intervention groups
The intervention group received 500 mg of the IMPOHelzavid herbal compound as 2 capsules every 12 hours for up to 72 hours. The control group received two capsules of the same color containing breadcrumbs every 12 hours for 72 hours. To equalize the smell and taste of the capsules in each of the two groups, 2 milligrams of bitter watermelon powder and 5 milligrams of beet extract powder are added to each 1 gram of drug content or placebo.
Main outcome variables
Duration of hospitalization, need for mechanical ventilation, and mortality.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N18
Registration date:2023-08-22, 1402/05/31
Registration timing:prospective
Last update:2023-08-22, 1402/05/31
Update count:0
Registration date
2023-08-22, 1402/05/31
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing of efficacy of IMPOHelzavid herbal compound on mortality of hospitalized patients with community-acquired pneumonia
Public title
Effect of IMPOHelzavid herbal compound on hospitalized patients with community-acquired pneumonia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pneumonia
Exclusion criteria:
Patients admitted in ICU
Patients with uncontroled diabetes, hypertension and cardiovascular, respiratory, hepatic and renal underlying diseases
Age
From 40 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.SEMUMS.REC.1402.082
Health conditions studied
1
Description of health condition studied
Community acquired pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified organism
Primary outcomes
1
Description
Blood oxygen saturation
Timepoint
At beginning and daily every 6 hours up to end of the study
Method of measurement
Pulse Oximeter
2
Description
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
3
Description
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)
Secondary outcomes
1
Description
Hospitalization
Timepoint
During the study
Method of measurement
Number of hospitalization day
2
Description
Need to mechanical ventilation
Timepoint
During the study
Method of measurement
If mechanical ventilation is required, the patient will be excluded from the study.
3
Description
Mortality
Timepoint
During the study
Method of measurement
The number of expired patients
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: They will receive two capsules, containing breadcrumbs every 12 hours for 72 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Fatemeh Taghavi Raeisi
Street address
Amin Avenue
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
F_taghavi759@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Basij Blvd.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Farhad Malek
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pulmonology
Street address
Amin Avenue
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
farhadmalek42@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Farhad Malek
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amin Avenue
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
farhadmalek42@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researchman
Latest degree
Bachelor
Other areas of specialty/work
Epidemiology
Street address
Amin Avenue
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2120
Email
mehrdadzahmatkesh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Research results are published in the form of articles.
When the data will become available and for how long
The article will be published about six months after the completion of the study.
To whom data/document is available
There is no objection or prohibition for public use of the published article.
Under which criteria data/document could be used
The use of data with reference to the source is unrestricted.
From where data/document is obtainable
Vice Chancellor for Research, Semnan University of Medical Sciences of direct contact with person responsible for scientific inquiries.
What processes are involved for a request to access data/document
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.