Evaluation of the effect of Thyme oxymel on respiratory symptoms and spirometry test results in patients with cystic fibrosis
Design
Randomized, parallel clinical trial with control group, triple blinded, phase 3 on 50 patients. Excel software rand function was used for randomization.
Settings and conduct
Samples will be selected among cystic fibrosis (CF) referrals to the CF clinic of Akbar Hospital in Mashhad. The drug or placebo is added to the main drug of the selected patients for 8 weeks by a pediatric pulmonologist. Changes in clinical signs, spirometry parameters, and Impedance Ocsillometry (IOS) results are measured in patients. Patients, the physician who assigns samples to groups, and the data analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Cystic fibrosis patients aged 5-18 who have been diagnosed with cystic fibrosis by a specialist doctor and are being treated at home; Exclusion criteria: History of allergy to thyme, vinegar, or honey; consumption of systemic corticosteroid by the patient; Patients needing hospitalization
Intervention groups
Thyme oxymel syrup containing aqueous extract of honey, vinegar and thymus volgaris twice a day, 5 ml twice per day for 8 weeks is added to the common treatments of patients. The control group also received sugar syrup with the same color and consistency as the patients in the intervention group.
Main outcome variables
The effect of the drug on the clinical symptoms of patients based on the cystic fibrosis quality of life questionnaire; The effect of the drug on the patients' spirometry parameters; The effect of the drug on the result of patients' IOS results.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059345N1
Registration date:2024-05-28, 1403/03/08
Registration timing:registered_while_recruiting
Last update:2024-05-28, 1403/03/08
Update count:0
Registration date
2024-05-28, 1403/03/08
Registrant information
Name
Fatemeh Sajedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 940 0716
Email address
sajedirf94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-24, 1402/09/03
Expected recruitment end date
2024-06-23, 1403/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Thyme oxymel on clinical symptoms and spirometry parameters of patients with cystic fibrosis
Public title
The effect of Thyme oxymel on patients with cystic fibrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cystic fibrosis
Age above 5 years
Outpatients
Exclusion criteria:
Patients less than 5 years old
Hospitalization for any reason during treatment
History of allergy to thyme, vinegar or honey
Taking systemic corticosteroids by the patient
Occurrence of special medical conditions and not using the medicine by the patient
Age
From 5 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method in this study will be block-randomization. each block has four numbers. The sequence produced by the https://www.sealedenvelope.com/ will be provided to the researchers by the project methodologist and will be placed in sealed, opaque, and numbered envelopes. The project researcher opens one of the envelopes when each patient enters the clinic and the patient will be assigned to the group mentioned in the envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo and druge _same packaged_ marked by specified code and consumption instruction. patient and attentive and analyzer are blind ,at the end of study outcomes decode by researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Mashhad University of Medical Sciences - Biomedical Research Ethics Committee
Street address
Azadi Squair- Kalantary Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2024-04-27, 1403/02/08
Ethics committee reference number
IR.MUMS.REC.1403.028
Health conditions studied
1
Description of health condition studied
Cystic Fibrosis
ICD-10 code
E84.0
ICD-10 code description
Cystic fibrosis with pulmonary manifestations
Primary outcomes
1
Description
Changes in patients' clinical symptoms
Timepoint
At the beginning and 8 weeks after the drug intervention
Method of measurement
Cystic fibrosis quality of life questionnaire
2
Description
Changes in respiratory test results
Timepoint
At the beginning and 8 weeks after the drug intervention
Method of measurement
Spirometry
3
Description
Changes in respiratory test results
Timepoint
At the beginning and 8 weeks after the drug intervention
Method of measurement
IOS (Impedance Ocsillometry)
Secondary outcomes
1
Description
Changes in patients' quality of life
Timepoint
First and 8 weeks after drug intervention
Method of measurement
Cystic fibrosis quality of life questionnaire
Intervention groups
1
Description
Intervention group: Patients receive 10 ml of thyme oxymel syrup, including aqueous extract of thymus vulgaris, vinegar, and honey, divided into two parts in the morning and evening for 8 weeks. This syrup is formulated and produced under standard conditions by the research team in the pharmaceutical laboratory of the School of Persian and Complementary Medicine of Mashhad University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: Patients receive 15 ml of placebo syrup, including simple sugar, divided into two parts in the morning and evening for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cystic fibrosis Clinic of Akbar Hospital
Full name of responsible person
Dr Seyed Javad Sayedi
Street address
Azadi Square, Kalantary Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
SayediJ@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Deputy of Research and Technology, Ghoreishi Building, Daneshgah St, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3881 4043
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Fatemeh Sajedi
Position
PhD students
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, Kalantary Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
sajedif991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Alireza Derakhshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, Kalantary Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
DerakhshanAR@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Sajedi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Azadi Square, Kalantary Street, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
sajedif991@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
After the end of the study, the results will be published in the form of an original paper in an international journal and will be available to other researchers. Access to raw data collected in this study will be possible after obtaining permission from the original researchers and the corresponding author. Using the data of this project to carry out research or publish a new article requires written permission from the person responsible for scientific inquiries in this research.
When the data will become available and for how long
Access starts from the time the article is published until one year later.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Access to raw data collected in this study will be possible after obtaining permission from the original researchers and the corresponding author. Using the data of this project to carry out research or publish a new article requires written permission from the person responsible for scientific inquiries in this research.
From where data/document is obtainable
Applicants can communicate with the person who is scientifically responsible for this research via email.
What processes are involved for a request to access data/document
Send the request via the mentioned email and explain the reason for the request and the applicant's details and a description of possible uses Accepting or rejecting the request from the main researcher of the research by email.