Determining the effect of hybrid herbal powder on asthma symptoms and spirometric indices
Design
A clinical trial with a control group, a randomized, and triple blinds. The sample size is 51 in the experimental group and 51 in the control group
Settings and conduct
Consumption of combined herbal powder for one month in the experimental group and placebo powder in the control group. The study site is the clinic of Amir Al-Momenin Hospital in Arak. Patients are not aware of being in the experimental or control group.
Participants/Inclusion and exclusion criteria
Diagnosis of asthma, absence of other chronic obstructive pulmonary diseases, absence of respiratory infection in a recent month, no smoking and drugs
Intervention groups
Consumption of combined herbal powder in the intervention group and taking placebo powder in the control group
Main outcome variables
Asthma symptoms, spirometry indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170501033751N4
Registration date:2022-03-19, 1400/12/28
Registration timing:registered_while_recruiting
Last update:2022-03-19, 1400/12/28
Update count:0
Registration date
2022-03-19, 1400/12/28
Registrant information
Name
rezvan ghafarzadegan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3426 2226
Email address
rghafarzadegan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-07-11, 1401/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined herbal powder on the severity of symptoms (couph and dyspnea) and spirometery indexes in patients with asthma
Public title
The effect of combined herbal powder on asthmatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
desire to participate in the study
Age 18 to 65 years
Asthma at the diagnosis of a pulmonologist
Absence of other respiratory diseases including bronchitis, chronic obstructive pulmonary disease
Exclusion criteria:
Evidence of respiratory infection in a recent month
Recent exacerbation of clinical symptoms of asthma
Unwanted side effects of herbal medicine
Reluctance to cooperate in any of the stages of research
Do not use herbal medicine as directed Herbal capsules provided)
Change of standard drugs used by the patient during the study
Perform surgery and general anesthesia during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected based on purpose and will be randomly assigned in two groups of intervention and control by balanced block randomization method.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be conducted in a three-blind design so that the participants, physician and treatment team of the respiratory clinic and the researcher based in the clinic will not have information about the allocation of individuals and the type of intervention applied to the participant.After a person who is eligible to participate in the study is introduced to the researcher by the clinic physician, the researcher informs the coordinating center of the relevant person by phone; In the coordinator center, the researcher is assigned based on the order of pre-determined codes and the envelope number that must be given to the person is notified. The number written on the envelopes is a random and irregular three-digit number. These numbers and codes for each person will be kept on confidential forms on the Coordination Center. The team based at the Coordination Center will not have direct contact with the participants and will not interfere in the collection of information and analysis of study data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Khomein School of Medical Sciences
Street address
Basij square
City
khomein
Province
Markazi
Postal code
3881857573
Approval date
2022-03-05, 1400/12/14
Ethics committee reference number
ir.khomein.rec.1400.020
Health conditions studied
1
Description of health condition studied
asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthma symptoms and spirometry indicators
Timepoint
Before the intervention and one month after the start of the use of herbal powder
Method of measurement
Using an asthma symptom questionnaire and a spirometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:500 mg mixed plant powder (containing 1000 mg of ocimum basilicum seeds. 1000 mg of plantago seeds • 1000 mg of plantago ovata forssk seeds • 1000 mg of Salvia macrosiphon seeds • 1000 mg of alyssum alyssoides seeds) orally at a rate of two sachets per day (to For a month). This powder is made by Ghaem Daroo Pharmaceutical Company.
Category
Treatment - Drugs
2
Description
Control group: Consumption of sachets containing 5000 mg of toasted bread powder, which is similar in color and appearance to herbal powder, in the amount of two sachets per day orally (for one month). Placebo powder is made by Ghaem Daroo Pharmaceutical Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital in Arak
Full name of responsible person
rezvan ghafarzadegan
Street address
Basij square
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
rghafarzadegan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Street address
Basij Square
City
khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
hamid52us@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
rezvan ghafarzadegan
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij square
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
rghafarzadegan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamid Momeni
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Square
City
Khomein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
hamid52us@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
rezvan ghafarzadegan
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Square
City
Khimein
Province
Markazi
Postal code
3881743364
Phone
+98 86 4622 1534
Email
rghafarzadegan@gmail.com
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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is sharable when unrecognizable
When the data will become available and for how long
1400
To whom data/document is available
all researcher
Under which criteria data/document could be used
to related research
From where data/document is obtainable
khomein medical university.Deputy of Education and Research. Mr. Hamid Momeni. Phone number: 08646221534. Fax: 08646224143
What processes are involved for a request to access data/document
Submit a written request via fax to receive documents to the Vice Chancellor for Education and Research of Khomein School of Medical Sciences and after a maximum of one month, receive information about the research