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Evaluating the effects of saffron on fatigue symptoms in patients with chronic obstructive pulmonary disease

Phase 3
Recruiting
Conditions
Chronic obstructive pulmonary disease.
Other chronic obstructive pulmonary disease
Registration Number
IRCT20151227025726N34
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
70
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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.;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.
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