Evaluating the effects of Garlic supplementation on clinical outcomes and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD)
Determination of the effects of Garlic supplementation on clinical outcomes and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD)
Design
A controlled, parallel groups, randomized, single blinded and phase 3 clinical trial on 70 patients
Settings and conduct
This study is conducted on 70 patients referred to Masih Daneshvari hospital clinic. Researchers are blinded to the study groups. Blinding was performed by the nurse.
Participants/Inclusion and exclusion criteria
Inclusion criteria for patients: People over 18 years of age with chronic obstructive pulmonary disease and chronic fatigue syndrome (based on IOM criteria) at the same time who are referred to the lung clinic of Masih Daneshvari Hospital.
Exclusion criteria for patients: Pregnancy and breastfeeding, Taking any anticoagulant drugs, Allergy to garlic or formulation components, AIDS and Asthma.
Intervention groups
Patients in the intervention group received capsules containing ۵۰۰ mg of garlic extract (prepared by Goldaru company) twice a day for two months. Patients in the control group will not receive garlic supplementation.
Main outcome variables
The effect of garlic supplementation on the quality of life in COPD patients using SGRQ questionnaires
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N36
Registration date:2024-04-15, 1403/01/27
Registration timing:prospective
Last update:2024-04-15, 1403/01/27
Update count:0
Registration date
2024-04-15, 1403/01/27
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-05, 1403/02/16
Expected recruitment end date
2025-05-06, 1404/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of Garlic supplementation on clinical outcomes and quality of life in patients with Chronic Obstructive Pulmonary Disease (COPD)
Public title
Evaluating the effects of herbal Garlic supplementation on clinical outcomes and quality of life inpatients with Chronic Obstructive Pulmonary Disease (COPD)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are diagnosed with COPD. Diagnosis is based on FEV1/FVC ratio less than 0.7.
Exclusion criteria:
Allergy to garlic
Patients who need surgery
Pregnant and lactating patients
Cancer patients
Patients with thyroid malignancy
Asthma
Patients who take anticoagulant drugs
AIDS patients
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used. Thirty five block including 2 patients generated with the help of the online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, one patient is assigned to the garlic group and one patient to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher is unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical sciences
Street address
Vali_e Asr Ave.,Niayesh junction,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
14155-6153
Approval date
2024-01-15, 1402/10/25
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.233
Health conditions studied
1
Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Evaluating the effects of Garlic supplementation on clinical outcomes and quality of life in patients with Chronic Obstructive Pulmonary Disease
Timepoint
Beginning of the study, End of the first month, End of the second month
Method of measurement
mMRC, BODE and SGRQ questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group received capsules containing 500mg of garlic extract (prepared by Goldaru company) twice a day for two months.
Category
Treatment - Drugs
2
Description
Control group: patients in the control group will not received garlic supplementation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Daar-Abad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
fzh.dastan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zargh
Street address
Tehran-Valiasr Street intersection Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Samin Iranikhah
Position
Studen
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
City
Tehran
Province
Tehran
Postal code
19569-44413
Phone
+98 21 2712 2227
Email
samin98ir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 2712 2227
Email
f_dastan@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valiasr st, shahid beheshti university, faculty of pharmacy, clinical pharmacy department
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 912 270 5933
Fax
Email
f_dastan@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
All potential data can be shared after blinding.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
For research purposes and meta-analysis studies.
From where data/document is obtainable
Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document
Official letter to the researchers through Email (fzh.dastan@gmail.com)