Determining the effects of crocus sativus herbal product on the improvement of chronic fatigue syndrome in patients with chronic obstructive pulmonary disease.
Determining the effects of crocus sativus herbal product on improving the quality of life in patients with chronic obstructive pulmonary disease.
Design
A controlled, parallel groups, randomized, double 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. Patients and researchers are blinded to the study groups. Blinding was performed by the drug manufacturing company (Faran Shimi).
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 that they refer to the lung clinic of Masih Daneshvari Hospital.
Exclusion criteria for patients:
Pregnancy and breastfeeding
Rheumatoid diseases and osteoarthritis
electrolyte disorders
adrenal insufficiency
Obstructive sleep apnea disease
Patient with acute exacerbation in the last month
History of central nervous system disease
Taking any sleep-sedative drugs, stimulant drugs, antidepressants, anticoagulant drugs
Allergy to saffron or formulation components
Having any known neurological and mental illness
Intervention groups
Patients in the intervention group received capsules containing 30 mg of dry saffron extract (prepared by Faran Shimi company) twice a day for two months. In the control group, patients use placebo in the same way.
Main outcome variables
The effect of crocus sativus on chronic fatigue syndrome in COPD patients using Chronic Respiratory Questionnaire (CRQ) and Manchester COPD Fatigue Scale (MCFS) questionnaires
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N34
Registration date:2023-10-09, 1402/07/17
Registration timing:prospective
Last update:2023-10-09, 1402/07/17
Update count:0
Registration date
2023-10-09, 1402/07/17
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
2023-10-12, 1402/07/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effects of Crocus Sativus herbal product on Chronic Fatigue Syndrome in Patients with Chronic Obstructive Pulmonary Disease
Public title
Evaluating the effects of saffron on fatigue symptoms in patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old with chronic obstructive pulmonary disease and chronic fatigue syndrome at the same time
Exclusion criteria:
Pregnancy and breastfeeding
suffering from Rheumatoid diseases and osteoarthritis
Having electrolyte disorders
Suffering from adrenal insufficiency
Suffering from obstructive sleep apnea disease
Suffering from other lung diseases such as asthma, lung fibrosis
Patient with acute exacerbation of chronic obstructive pulmonary disease in the last month
History of central nervous system disease (stroke, epilepsy, tumor, history of neurosurgery)
Taking any sleep-sedative drugs, stimulant drugs, antidepressant and anticoagulant drugs
Allergy to saffron or formulation components
Having any known Nervous and mental illness
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
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 crocus sativus group and one patient to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients included to the study are randomized to two groups of drug and control (crocus sativus and placebo) by a randomizer according to the randomization list taken from www.sealedenvelope.com. The researcher and data analyst only receive the data in code and were not aware of patients' assignments to the two groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Pharmacy, Nursing and Midwifery Faculties Shahid Beheshti University
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2023-05-23, 1402/03/02
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.033
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
Investigating the effect of herbal product containing crocus sativus on chronic fatigue syndrome in patients with COPD
Timepoint
The beginning of the study, the end of the first month and the end of the second month
Method of measurement
Manchester COPD Fatigue Scale (MCFS) and Chronic Respiratory Questionnaire (CRQ) questionnaire
Secondary outcomes
1
Description
Investigating the effect of crocus sativus herbal product on the quality of life of patients with chronic obstructive pulmonary disease
Timepoint
The beginning of the study, the end of the first and second month
Method of measurement
St. George's Respiratory Questionnaire (SGRQ) questionnaire
2
Description
Investigating the effect of crocus sativus herbal product on the severity of shortness of breath in patients with COPD
Timepoint
The beginning of the study, the end of the first and second month
Method of measurement
Modified Medical Research Council (mMRC) and Body mass index, airflow Obstruction, Dyspnea, and Exercise capacity (BODE Index) score
Intervention groups
1
Description
Intervention group: Patients in the intervention group received capsules containing 30 mg of dry saffron extract (Duralife® prepared by Faran Shimi Company) twice a day for two months.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group received placebo capsules prepared by Faran Shimi Company twice a day for two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad.
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
f_dastan@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran 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
Reza Mahmoodian
Position
Resident
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
mahmoodian.reza@yahoo.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
Assisstant Professor
Latest degree
Specialist
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
Reza Mahmoodian
Position
Resident
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
mahmoodian.reza@yahoo.com
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)