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The Joint Effects of Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, and Coriander seed for controlling asthma symptoms

Phase 1
Conditions
Asthma.
Asthma
Registration Number
IRCT20220614055167N5
Lead Sponsor
Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

One unplanned asthma-related visit to the emergency department or clinic in the past 12 months
One night hospitalization in the last 12 months
Disturbed sleep more than twice in the last month
Asthma symptoms =8 times in the last month
Use of a ß2 agonist =8 times in the past month
Receiving two short courses (3-7 days) of oral corticosteroids in the past 12 months
Funcional expiratory volume in the first second <80% predicted and use of inhalational corticosteroids (ICS) for at least 1 month prior to study entry
Women of childbearing potential must be sexually inactive or use effective birth control measures, as determined by the researcher, during the study period and have a negative pregnancy test at the beginning of the study

Exclusion Criteria

People with acute illness (such as colds and flu) within two weeks before the screening visit
Any history of systemic disease that the researcher believes would prevent the subject from participating in this study, including viral hepatitis, history of chronic obstructive pulmonary disease, emphysema or other chronic respiratory diseases, underlying kidney, liver, thyroid and diabetes and cardiovascular diseases, abnormal liver function (alanine aminotrasferase/aspartate aminotransferase (ALT/AST) and bilirubin more than 1.25 times the upper limit of normal), abnormal bone marrow function (White blood cells less than 4000/mm3, platelets less than 100,000/mm3 and hemoglobin less than 11 g/dL), abnormal kidney function (blood urea nitrogen (BUN) and creatinine more than 1.25 times the upper limit of normal), abnormal electrocardiogram, forced expiratory volume in 1 second (FEV1) <50% predicted
Participation in another experimental treatment study within 30 days prior to this study
History of alcohol or drug use
Pregnant or lactating women
Subjects treated with Omalizumab or immunotherapy for asthma
Use of other herbal compounds for the treatment of asthma in the last month before entering the study
History of allergy to one of the components of Boswellia serrata, Pimpinella anisum, Hyssopus officinalis, Eucalyptus, or Coriander seed

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Forced expiratory volume in 1 second. Timepoint: Days 30 and 90. Method of measurement: Spirometry.;Forced expiratory volume in 1 second to Forced vital capacity ratio. Timepoint: Days 30 and 90. Method of measurement: Spirometry.
Secondary Outcome Measures
NameTimeMethod
Symptoms of asthma. Timepoint: Days 30 and 90. Method of measurement: Asthma Control Test questionnaire.;Assessment of quality of life. Timepoint: Days 30 and 90. Method of measurement: Asthma quality of life questionnaire.;Assessment of sleep quality. Timepoint: Days 30 and 90. Method of measurement: Pittsburgh Sleep Quality Index.;Adverse events. Timepoint: Days 30 and 90. Method of measurement: Questionnaire.
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