The effect of saffron on pulmonary function and serum levels of Interleukin-6 and Tumor Necrosis Factor-α in patients with Chronic Obstructive Pulmonary Disease
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General information
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Adding variables to the study
Adding variables to the study
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افزودن متغیرهای مورد مطالعه
افزودن متغیرهای مورد مطالعه
Ethics committees
#1
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2019-11-03, 1398/08/12
2019-11-03 00:00:00
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IR.ARUMS.REC.1398.428
IR.ARUMS.REC.1398.428
Primary outcomes
#1
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Total oxidant status (TOS)
Total oxidant status (TOS)
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وضعیت کل اکسیدانت
وضعیت کل اکسیدانت
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Beginning of study and 12 weeks after intervention
Beginning of study and 12 weeks after intervention
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شروع مطالعه و 12 هفته بعد از مداخله
شروع مطالعه و 12 هفته بعد از مداخله
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Laboratory
Laboratory
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آزمایشگاهی
آزمایشگاهی
#2
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Total antioxidant capacity (TAC)
Total antioxidant capacity (TAC)
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ظرفیت کلی آنتی اکسیدانت
ظرفیت کلی آنتی اکسیدانت
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Beginning of study and 12 weeks after intervention
Beginning of study and 12 weeks after intervention
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شروع مطالعه و 12 هفته بعد از مداخله
شروع مطالعه و 12 هفته بعد از مداخله
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Laboratory
Laboratory
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آزمایشگاهی
آزمایشگاهی
#3
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Nuclear factor kappa B (NF-κB)
Nuclear factor kappa B (NF-κB)
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فاکتور هسته ای کاپا سلول ب
فاکتور هسته ای کاپا سلول ب
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Beginning of study and 12 weeks after intervention
Beginning of study and 12 weeks after intervention
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شروع مطالعه و 12 هفته بعد از مداخله
شروع مطالعه و 12 هفته بعد از مداخله
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Laboratory
Laboratory
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آزمایشگاهی
آزمایشگاهی
Protocol summary
Study aim
Evaluation of the saffron effects on serum levels of interleukin-6 and tumor necrosis factor-alpha in chronic obstructive pulmonary disease (COPD).
Design
A randomized, double-blind with parallel groups in placebo-controlled clinical trial.
Settings and conduct
COPD patients referred to pulmonary clinic of Imam Khomeini Hospital in Ardabil, who fulfilled inclusion criteria, were invited to participate in this study. Demographic data (age, height, weight, body mass index, exacerbation rate, smoking history), MMRC (modified Medical Research Council) dyspnea scale and COPD assessment test (CAT) are completed by patients. Then, spirometry, pulse-oximetry, and 6-minute walk distance tests are administered. Blood sample is drawn for serum IL-6 and TNF-α levels analysis. Coded pockets containing saffron and placebo (A or B codes) are randomly assigned by a medical physician to the patients and the control groups.
Then, 30 mg saffron tablets and the placebo are prescribed once daily for 12 weeks. After 4 weeks of intervention complete examination and drug side effects are conducted by physician. At the end of the 12th weeks, physical examination, spirometry, pulse-oximetry, CAT questionnaire, 6-minute walk distance test and blood sampling for serum IL-6 and TNF-α levels will be conducted.
Participants/Inclusion and exclusion criteria
Inclusion criteria: COPD patients; Age between 40-85 years; Clinically stable disease in previous 8 weeks; Acceptance of study design by patients. Exclusion Criteria: History of malignancy, Diabetes, Cardiac disease, Chronic inflammatory disease, Liver disease.
Intervention groups
Intervention group: Efficacy of saffron on pulmonary function and inflammatory markers in Chronic Obstructive Pulmonary Disease.
Control group: Receiving placebo in patients with Chronic Obstructive Pulmonary Disease.
Main outcome variables
The level of IL-6, TNF-α, Pulmonary Function Test
General information
Reason for update
Adding variables to the study
Acronym
IRCT registration information
IRCT registration number:IRCT20110109005579N2
Registration date:2019-09-17, 1398/06/26
Registration timing:prospective
Last update:2020-01-11, 1398/10/21
Update count:1
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Hassan Ghobadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 1401
Email address
h.ghobadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of saffron on pulmonary function and serum levels of Interleukin-6 and Tumor Necrosis Factor-α in patients with Chronic Obstructive Pulmonary Disease
Public title
Saffron effect in Chronic Obstructive Pulmonary Disease (COPD).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic Obstructive Pulmonary Disease
Age between 40-85
Clinically stable disease in previous 8 weeks
Acceptance of study design by patients
Exclusion criteria:
Active infectious disease
Bronchiectasis
Chronic inflammatory diseases
Active liver and kidney diseases
Cancer patients
Cardiac disease (myocardial infarction and unstable angina in previous 6 months)
Sensitivity to saffron
Age
From 40 years old to 85 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be recruited from patients that referred to the pulmonary clinic of Ardabil Imam Khomeini Hospital. Patients will be evaluated and in the case of satisfying inclusion criteria, they will be referred to the clinics nurse. A per-defined list will be utilized for subject's enrollment. The list consists two groups of trial and placebo (each 45 subjects) which was prepared by Excel using Randbetween function. Patients will be allocated in two groups by simple randomization. 45 "A" labeled and 45 "B" labeled sealed envelopes will be used by nurse to provide medicine and placebo to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, patient care student and outcome evaluator, person responsible for data collection don't aware from pocket contents.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences Ethic Committe
Street address
Internal Medicine Department, Emam Khomeini Hospital, Shahid Noe-Aghdam Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
56196-47531
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.ARUMS.REC.1397.279
2
Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences Ethic Committe
Street address
Internal Medicine Department, Emam Khomeini Hospital, Shahid Noe-Aghdam Street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
56196-47531
Approval date
2019-11-03, 1398/08/12
Ethics committee reference number
IR.ARUMS.REC.1398.428
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.8
ICD-10 code description
Other specified Chronic Obstructive Pulmonary Disease
Primary outcomes
1
Description
Serum Level of IL-6
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Laboratory
2
Description
Tumor Necrosis factor alpha (TNF-α)
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Laboratory
3
Description
Pulmonary Function Test
Timepoint
beginning of study and 12 weeks after intervention
Method of measurement
Laboratory (Spirometry Device)
4
Description
Total oxidant status (TOS)
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Laboratory
5
Description
Total antioxidant capacity (TAC)
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Laboratory
6
Description
Nuclear factor kappa B (NF-κB)
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Laboratory
Secondary outcomes
1
Description
COPD Assessment Test (CAT)
Timepoint
Beginning of study and 12 weeks after intervention
Dyspnea scale: Modified Medical Research Council (MMRC) questionnaire
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Modified Medical Research Council (MMRC) questionnaire
3
Description
Exercise scale: Six Minute Walk Distance (6MWD)
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Six Minute Walk Distance (6MWD) questionnaire
4
Description
Oxygen saturation of arterial blood
Timepoint
Beginning of study and 12 weeks after intervention
Method of measurement
Pulse oximetry
5
Description
Saffron side effects
Timepoint
4 weeks and 12 weeks after intervention
Method of measurement
Record of adverse effect in checklist
Intervention groups
1
Description
"Intervention group:" Patients with Chronic Obstructive Pulmonary Disease will be receive standard treatments based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline and 30mg/day Saffron Tablets for 12 weeks (Produced by: BuAli Institute of Pharmaceutical Sciences, Pharmaceutical Product Development Center, Sina Pharmaceutical Company, Reg. No. 48674).
Category
Treatment - Drugs
2
Description
"Control group:" Patients with Chronic Obstructive Pulmonary Disease will be receive standard treatments based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline and 30mg/day Saffron Placebo Tablets for 12 weeks (Produced by: BuAli Institute of Pharmaceutical Sciences, Pharmaceutical Product Development Center, Sina Pharmaceutical Company, Reg. No. 48674).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital, Ardabil
Full name of responsible person
Hassan Ghobadi
Street address
Internal Medicine Department, Emam Khomeini Hospital, Shahid Noe-Aghdam Street, Ardabil