1. Home
  2. Approved trials
  3. » فارسی

Investigation of safety and efficacy of GLARTA herbal syrup on improving the symptoms and complications of patients with pneumonia

Protocol summary

Study aim
Finding an effective and safe herbal medicine in improving the symptoms and complications of pneumonia
Design
This double-blind phase 2 clinical trial is performed in 60 patients with pneumonia. Patients by block randomization method are randomly assigned to 30 blocks of 2 patients. Each patient in the block then receives herbal or placebo syrup with code A or B. So that 30 patients are given herbal syrup and 30 people are given placebo. The duration of treatment is 6 days.
Settings and conduct
60 eligible patients with pneumonia will be selected and randomly divided into two groups of 30 each. The patients are given by nurse any of herbal or placebo syrup package for 6 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.
Participants/Inclusion and exclusion criteria
Patients infected with 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 Patients with severe dyspnea; Patients with reduced level of consciousness or need hospitalization in intensive care units; 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 and diabetes, cardiovascular disease and underlying respiratory disease
Intervention groups
Intervention group: patients in this group take one tablespoon of herbal syrup every 12 hours for 6 days. Control group: patients in this group take a tablespoon of placebo syrup every 12 hours for 6 days.
Main outcome variables
Shortness of breath; Cough; Blood oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001157N19
Registration date: 2022-12-26, 1401/10/05
Registration timing: registered_while_recruiting

Last update: 2022-12-26, 1401/10/05
Update count: 0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Hasan Fallah Huseini
Name of organization / entity
Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26 3476 4010
Email address
fallah@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-29, 1401/09/08
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of safety and efficacy of GLARTA herbal syrup on improving the symptoms and complications of patients with pneumonia
Public title
Effects of herbal product GLARTA on improving the symptoms of patients with penomenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with pulmonary infection aged 20 to 70 years who have the ability to take oral medication. Personal desire to participate in the project and the signing of a written consent
Exclusion criteria:
Patients with severe dyspnea, swallowing disorder, or the possibility of aspiration of food and patients who are unable to take medicine orally. Patients with refractory hypoxemia, decreased level of consciousness, hemodynamic instability, hypercapnia, or respiratory fatigue who require hospitalization in special care units. Patients with respiratory failure requiring mechanical ventilation Patients with immunodeficiency, including patients treated with corticosteroids, chemotherapy, malignancies, organ transplants, HIV patients Patients with underlying diseases including cardiovascular disease, uncontrolled blood pressure, uncontrolled diabetes, BMI > 40 pregnant women
Age
From 20 years old to 70 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
A random number table and block randomization method is used. In this method 60 eligible patients are assigned into 30 blocks of 2 patients. Then, each of the 2 patients in the block is randomly assigned to take herbal product or placebo, so that 30 patients assigned to each group. There is no significant difference between the patients in each group in terms of chest X-ray findings.
Blinding (investigator's opinion)
Double blinded
Blinding description
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 capsule 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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics Committees of Islamic Azad University, Shahrood Branch
Street address
Islamic Azad University, Shahrood Branch
City
Shahrood
Province
Semnan
Postal code
3619943189
Approval date
2022-11-26, 1401/09/05
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1401.051

Health conditions studied

1

Description of health condition studied
Acute upper respiratory infections of multiple and unspecified sites
ICD-10 code
J06
ICD-10 code description
Acute upper respiratory infections of multiple and unspecified sites

2

Description of health condition studied
Acute bronchiolitis
ICD-10 code
J21
ICD-10 code description
Acute bronchiolitis

3

Description of health condition studied
community acquired pneumonia
ICD-10 code
J14
ICD-10 code description
Pneumonia due to Hemophilus influenzae

4

Description of health condition studied
community acquired pneumonia
ICD-10 code
J13
ICD-10 code description
Pneumonia due to Streptococcus pneumoniae

5

Description of health condition studied
community acquired pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified organism

Primary outcomes

1

Description
Shortness of breath
Timepoint
At beginning and daily every 12 hours up to end of the study
Method of measurement
Modified Medical Research Council (MMRC)

2

Description
Cough
Timepoint
At beginning and daily every 12 hours up to end of the study
Method of measurement
simplified cough scale

3

Description
Blood oxygen saturation
Timepoint
At beginning and daily every 12 hours up to end of the study
Method of measurement
Pulse Oximeter

Secondary outcomes

1

Description
Fever
Timepoint
At beginning and then every 12 hours up to end of the study
Method of measurement
Termometer

2

Description
ALT
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

3

Description
Aspartate transaminase
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

4

Description
Alkaline phosphatase
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

5

Description
Creatinine
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

6

Description
BUN
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

7

Description
ESR
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

8

Description
CBC
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

9

Description
C-reactive protein
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

10

Description
Alanine transaminase
Timepoint
At beginning and end of the study
Method of measurement
Intravenous blood test

11

Description
Mortality rate
Timepoint
During the study
Method of measurement
Number

12

Description
Hospitalization
Timepoint
During the study
Method of measurement
Number

Intervention groups

1

Description
Intervention group: In addition to receiving standard medicines, patients of this group take one tablespoon of herbal syrup containing crude extracts of Artemisia, Licorice, Hyssop and natural sweetener stevia every 12 hours. The herbal syrup contains a mixture of medicinal plant extract powder and is manufactured by the ACECR Institute of Medicinal Plants. The herbal syrup is given as a supplement to patients for 6 days(20 cc daily and 120 cc in total) along with standard medications.
Category
Treatment - Drugs

2

Description
Control group: patients in this group in addition to receiving standard medications, take one tablespoon of placebo every 12 hours. The placebo syrupis given as a supplement to patients for 6 days along with standard medications. The placebo syrup contains all the components of the syrup except for the active ingredients (crude extract of medicinal plants) and the allowed edible color, which is formulated in the ACECR Institute of Medicinal Plants.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam ol-anbia hospital
Full name of responsible person
Nasrin Razavianzadeh
Street address
University Blvd, Khatam al-Anbia hospital with 1000 Patient Beds
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 912 173 1846
Email
nasrinrazavianzadeh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahebali Manafi
Street address
Shahrood University blvd, Islamic Azad University, Shahrood branch
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 23 3239 4279
Email
ali_manafi2005@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Nasrin Razavianzadeh
Position
Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
University Blvd, Khatam al-Anbia hospital
City
Shahrood
Province
Semnan
Postal code
3619943189
Phone
+98 23 3223 1442
Fax
+98 23 3233 1876
Email
nasrinrazavianzadeh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Homapharmed Company
Full name of responsible person
Mohammadreza Gholibeikian
Position
R & D
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 26, Nader Alley, North Jamalzadeh St, Enghelab Square
City
Tehran
Province
Tehran
Postal code
1418635643
Phone
+98 21 6276 9000
Fax
+98 21 6690 8071
Email
mgholibeikian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
university of Golestan
Full name of responsible person
Amirhosein Firouzi
Position
Ph.D candidate of Phytochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Phytochemistry
Street address
Shahid Beheshti St, Golestan university
City
Gorgan
Province
Golestan
Postal code
15759-49138
Phone
32254168 – 32254164 – 32254163 - 017
Fax
+98 17 3222 9068
Email
Amirhosein.firouzi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Research results are published in the form of articles
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be 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 project.
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
Nasrin Razavianzadeh University Blvd, Khatam al-Anbia hospital with 1000 Patient Beds, Shahrood Postal code: 3619943189 Phone: 09121731846 Email: nasrinrazavianzadeh@gmail.com
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 Islamic Azad University, Shahrood branch will follow up and inform.
Comments
Loading...