Objectives: One of the most common respiratory diseases is Chronic obstructive pulmonary disease Which have periods of acute exacerbation. This study survey the effect of Thymus Vulgaris inhaling on respiratory status of these patients. Design: This study is a blind randomized clinical trial so that researchers (collectors of questionnaires) will be blind about allocation of patients to control and intervention groups. Setting and conduct: The sample includes 60 patients with acute exacerbation of chronic obstructive pulmonary disease referred to the emergency department of 22 Bahman hospital of Gonabad. The patients were selected by convenience sampling and they will be allocated alternately in control and intervention groups. Improvement in respiratory status will be measured by reduced respiratory rate, increase in arterial oxygen saturation and Wheezing decline in lung lobes. In the intervention group, one percent Thymus Vulgaris inhaling that has been made by Exir gole sorkh Company will be used as much as 5 ml for the duration of 15 minutes with a inhaling treatment mask. In control group, distilled water inhaling will be received by the patients in the same amount and in the same duration. After the intervention, Information on dependent variables: respiratory rate, arterial oxygen saturation and wheezing will be collected by a research assistant who is not aware of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020732436N1
Registration date:2017-06-11, 1396/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Elyas Hosseinzadeh
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 6083
Email address
e.hosseinzadeh@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2017-03-10, 1395/12/20
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Thymus Vulgaris inhaling on respiratory status in patients with exacerbation of Chronic Obstructive Pulmonary disease
Public title
The effect of Thymus Vulgaris inhaling on Chronic Obstructive Pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: No anatomic face problem; Agree to participate in the research; oriented in time, place and person; Age between 50 and 80 years; not being allergic to perfumes and essences.
Exclusion criteria: Pregnancy; Nausea and vomiting; Intolerance to the mask used for inhalation therapy.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Samples will be divided into two experimental and control groups based on permutation blocks (blocks of size 4). It will be listed according to six possible ways (AABB, ABAB, ...) randomly and the arrangment of receiving intervention will be determined accordingly. For blinding the questionnaire will be completed by a person who is not aware of the research unit in the control group or the experimental group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Next to the Asian Road
City
Gonabad
Postal code
Approval date
2016-08-06, 1395/05/16
Ethics committee reference number
IR.Gmu.REC.1395.51
Health conditions studied
1
Description of health condition studied
Exacerbation Of Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Primary outcomes
1
Description
Respiratory Rate
Timepoint
Before and after intervention
Method of measurement
Count chest movement during respiration
2
Description
Arterial blood oxygen saturation
Timepoint
Before and after intervention
Method of measurement
Finger Pulse Oximeter
3
Description
Wheezing
Timepoint
Before and after intervention
Method of measurement
Lung sounds ascultation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one percent Thymus Vulgaris inhaling will be used as much as 5 ml for the duration of 15 minutes through inhaling treatment mask at the time of patients’ admission who are suffering from chronic obstructive pulmonary disease exacerbation (just for one time).
Category
Treatment - Other
2
Description
Control group:Distilled water inhaling will be used as much as 5 ml for the duration of 15 minutes with inhaling treatment mask at the time of patients’ admission who are suffering from chronic obstructive pulmonary disease exacerbation (just for one time).