Effect of Zofa (Nepeta bracteata Benth.) Product on Spirometric Parameters and Respiratory Symptoms in the Patients with Mild to Moderate Chronic Obstructive Pulmonary Disease
This is a double blind study, for assessing the effect of Zofa (Nepeta Bracteata Benth.)syrup and placebo on the treatment of Chronic Obstructive Pulmonary Disease. Qualified patients that fulfilled for inclusion criteria as the Mild to Moderate COPD, age of 18 and more, no allergy to the Lamiaceae family, no lactation or pregnancy, not having Diabetes and history of epilepsy and seizure. Patients in the exacerbation period are excluded. The sample size in each group is 30 (case and control). The dose of zofa (Nepeta Bracteata Benth.) syrup and placebo syrup is three times per day and each time 10 cc. The diagnosis is confirmed by a Pulmonologist through history and clinical examination. The patients are randomly divided to two groups of placebo and intervention by the random number table. Before entering the study, the required information is taken by the project agent and after receiving a written signed consent form and demographic questionnaire is filled. A standard questionnaire of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) includes constituent items such as cough, production of phlegm and chest tightness is filled before, two and four weeks after intervention.Spirometry will be done before and after four weeks of intervention. At the end of the study, relevant information is extracted and analyzed.
General information
Acronym
COPD (Chronic Obstructive Pulmonary Disease)
IRCT registration information
IRCT registration number:IRCT2015121925598N1
Registration date:2016-03-24, 1395/01/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-24, 1395/01/05
Registrant information
Name
Ali Abdolahinia
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9848
Email address
abdolahinia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research. Shahed University
Expected recruitment start date
2016-04-02, 1395/01/14
Expected recruitment end date
2016-08-10, 1395/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Zofa (Nepeta bracteata Benth.) Product on Spirometric Parameters and Respiratory Symptoms in the Patients with Mild to Moderate Chronic Obstructive Pulmonary Disease
Public title
Effect of Zofa (Nepeta bracteata Benth.) Product on Chronic Obstructive Pulmonary Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria:
Mild to Moderate Chronic Obstructive Pulmonary Disease; Age 18 and more; no allergy to the Lamiaceae family; no lactation or pregnancy; not having Diabetes and history of epilepsy and seizure
Excluding criteria: Exacerbation period
Age
From 18 years old to 139 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
No.1471, Between Forsat and Nosrat St, North Kargar Ave
City
Tehran
Postal code
-
Approval date
2016-02-09, 1394/11/20
Ethics committee reference number
IR.Shahed.REC.1394.84
Health conditions studied
1
Description of health condition studied
Chronic Obstractive Pulmonary Disease
ICD-10 code
J44.8
ICD-10 code description
Other specified chronic obstructive pulmonary disease
Primary outcomes
1
Description
Evaluation of quality of life of patients
Timepoint
The time of study inclusion and two and four weeks later.
Method of measurement
COPD Assessment Test (CAT) Questionnair
2
Description
Chenge of FEV1 (Forced Expiratory volume in 1 second)
Timepoint
Before treatment and four weeks after treatment
Method of measurement
Spirometry super Spiro, Micro medical company, England.
Secondary outcomes
empty
Intervention groups
1
Description
Zofa Product (Syrup),Oral, 10cc, Three times of day for four weeks
Category
Treatment - Drugs
2
Description
Placebo Product (Syrup), Oral. 10 cc, Three times a day for four weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Masih Daneshvari Hospital
Full name of responsible person
Ali Abdolahinia
Street address
End of Porebtehaj St, Darabad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahed University
Full name of responsible person
Dr. Mohsen Naseri
Street address
No.1471, Between Forsat and Nosrat St, North Kargar Ave
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahed University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Ali Abdolahinia
Position
MD.
Other areas of specialty/work
Street address
No.1471, Between Forsat and Nosrat St, North Kargar Ave