1. Home
  2. Approved trials
  3. » فارسی

The effect of hydro – alcoholic extracts of Zataria multiflora on patients with chronic obstructive pulmonary disease

Protocol summary

Summary
Objective: The effect of hydro – alcoholic extracts of Zataria multiflora on patients with chronic obstructive pulmonary disease Study design: Randomize, Double blind, control with placebo, second phase of clinical trial Method: In this study, sixty COPD patients were randomly divided into three groups (each group of twenty people). In the first group five mg/kg of hydro – alcoholic extracts of Zataria multiflora, in the second group ten mg/kg of hydro – alcoholic extracts of Zataria multiflora and in the third group placebo daily as oral syrup in three servings for two month will be prescribed. Blood and sputum samples of patients collected at baseline, one month after the start and end of the two months. Main conditions of entry and departure of participants: Inclusion criteria: Diagnosis of chronic obstructive pulmonary disease based on spirometry test and clinical symptoms Exclusion criteria: Having other lung diseases, cardiovascular diseases, chronic inflammatory diseases, acute infections, malignancies, autoimmune diseases and immunodeficiency Interventions: five mg/kg of hydro – alcoholic extracts of Zataria multiflora, ten mg/kg of hydro – alcoholic extracts of Zataria multiflora and also placebo Main outcome variables: The evaluation of clinical symptoms, wheezing rate by chest auscultation, measurement of lung function tests, measurement of inflammatory mediators in serum and sputum

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016112729191N2
Registration date: 2017-01-07, 1395/10/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-07, 1395/10/18
Registrant information
Name
Vahideh Ghorani Sirjani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8565
Email address
ghoranisv921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydro – alcoholic extracts of Zataria multiflora on patients with chronic obstructive pulmonary disease
Public title
The effect of Zataria in the treatment of chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of chronic obstructive pulmonary disease based on spirometry test; clinical symptoms Exclusion criteria: Having other lung diseases; cardiovascular diseases; chronic inflammatory diseases; acute infections; malignancies; autoimmune diseases; immunodeficiency
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Building Ghoreshi, Central Organization of Mashhad University of Medical Sciences, Daneshgah Avenue
City
Mashhad
Postal code
1394491388
Approval date
2016-01-16, 1394/10/26
Ethics committee reference number
IR.MUMS.REC.1394.610

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Evaluation of clinical symptoms including cough, breathlessness, wheeze
Timepoint
Before the intervention, one month after the start of intervention and the end of two months
Method of measurement
Standard questionare

2

Description
Wheezing rate
Timepoint
Before the intervention, one month after the start of intervention and the end of two months
Method of measurement
Chest auscultation

3

Description
Lung function tests
Timepoint
Before the intervention, one month after the start of intervention and the end of two months
Method of measurement
Spirometry

4

Description
Inflammatory mediators in blood serum and sputum
Timepoint
Before the intervention, one month after the start of intervention and the end of two months
Method of measurement
Standard kits

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Hydro – alcoholic extracts of Zataria multiflora, 5 mg/kg daily as oral syrup (made by the Faculty of Pharmacy, Mashhad University of Medical Sciences), three times a day for two months
Category
Treatment - Drugs

2

Description
Hydro – alcoholic extracts of Zataria multiflora, 10 mg/kg daily as oral syrup (made by the Faculty of Pharmacy, Mashhad University of Medical Sciences), three times a day for two months
Category
Treatment - Drugs

3

Description
Placebo daily as oral syrup (made by the Faculty of Pharmacy, Mashhad University of Medical Sciences), three times a day for two months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Vahideh Ghorani Sirjani
Street address
Emam Reza Hospital, Emam Reza square, Doktora intersection
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Department of Pharmaceutics and Nanotechnology, Faculty of Pharmacy, Ferdowsi University campus, Azadi square
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Vahideh Ghorani Sirjani
Position
Pharmaceutical sciences PhD student
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Ferdowsi University campus, Azadi square
City
Mashhad
Postal code
9177948564
Phone
+98 51 3882 8888
Fax
+98 38828560
Email
Ghoranisv921@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Hossein Boskabady
Position
MD, PhD, Physiology
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Ferdowsi University campus, Azadi square
City
Mashhad
Postal code
9177948564
Phone
+98 51 3882 8897
Fax
+98 38828560
Email
Boskabadymh@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahideh Ghorani Sirjani
Position
Pharmaceutical sciences PhD student
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Ferdowsi University campus, Azadi square
City
Mashhad
Postal code
-
Phone
00
Fax
-
Email
Ghoranisv921@mums.ac.ir
Web page address
www.mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...