The effect of hydroalcoholic rosemary extract on cognitive function، pulmonary function and physical activity daily of living of patients with chronic obstructive pulmonary disease
Determining the effect of hydroalcoholic rosemary extract on cognitive function، pulmonary function and physical activity daily of living of patients with chronic obstructive pulmonary disease
Design
Clinical trial with control group،with parallel groups،triple-blind،randomized control
Settings and conduct
The intervention will be the administration of rosemary extract and placebo for 8 weeks (60 days).Blinding will be done in a triple blind method
Participants/Inclusion and exclusion criteria
Patients between the ages of 40 and 80 with a diagnosis of COPD based on grade 1 to 3 GOLD criteria approved by spirometry and physician who have mild to moderate cognitive impairment based on the MMSE test with a minimum score of 23.If during the study،in addition to taking the main treatment drugs،the patient needed to take drugs that affect cognitive or pulmonary function or the amount of daily activity(such as muscle relaxants،etc)or in other pulmonary rehabilitation programs or participate in meditation and yoga or be admitted during the study.
Intervention groups
60 capsules with a dose of 500 mg will be placed in two envelopes A and B and will be given to two groups of patients in the lung clinic.The capsules contain rosemary extract and placebo (twice a day per hour).7 to 9 in the morning and maintaining a distance of 12 hours،again at 19 to 21 at night،one to two hours before breakfast or dinner and with a glass of water will be consumed by patients.The intervention group includes 40 patients who consume rosemary capsules and in the control group there are 40 patients who consume corn flour capsules as a placebo.
Main outcome variables
Cognitive function score based on the Montreal questionnaire،Daily activity score based on the Lawton and London questionnaire،FEV1 and FVC scores and FEV1 to FVC ratios based on spirometry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150919024080N16
Registration date:2020-08-25, 1399/06/04
Registration timing:registered_while_recruiting
Last update:2020-08-25, 1399/06/04
Update count:0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-24, 1399/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroalcoholic rosemary extract on cognitive function، pulmonary function and physical activity daily of living of patients with chronic obstructive pulmonary disease
Public title
The effect of rosemary on cognitive and pulmonary function and daily activity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 and 80 years
The ratio of FEV1 to FVC is less than 0.7 exhalation pressure volume per second (FEV1)،less than 70% of reference value and increase in FEV1 less than 10% after inhalation of beta-two agonists
Detection of COPD based on grade one to three gold criteria approved by spirometry and physician
Patients with mild to moderate cognitive impairment based on MMSE test with a minimum score of 23
Have a history of smoking at least ten packs of cigarettes a year
At least one year has passed since the diagnosis of COPD in the patient
Do not take any herbal medicine supplements effective in improving cognitive function and lung function and daily activity (such as Ginseng،Thyme،Nigella sativa،Chamomile،etc)from two months ago
No alcohol،hookah and drugs
Do not take antioxidants as a supplement during the last three months(vitamin E،Omega3،α-tocopherol،etc)
Exclusion criteria:
Lack of motivation of the patient to continue cooperation
Hospitalization during the study
Neurological disease،cancer،acute infection and known mental disorders(anxiety،depression and delirium)
Patient deterioration،unstable hemodynamic status،life threatening arrhythmias
Participate in other pulmonary rehabilitation programs or meditation and yoga
Do not take the capsules for two consecutive days
Demonstrate sensitivity to capsules
If the patient needs to take drugs that affect cognitive or pulmonary function or the amount of daily activity (such as muscle relaxants،etc)during the study،in addition to the main treatment drugs،excluded from the study
Patients receiving vasodilators include organic nitrates and people with pulmonary ،hypertension،obstructive sleep apnea،malignancies،gastrointestinal abnormalities،recent surgery،severe endocrine disease،kidney disease،liver disease،inflammatory and infectious disease،and musculoskeletal disease active that causes impairment in exercise and respiratory capacity
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After baseline evaluations such as pulmonary function assessment tests by a pulmonary specialist،patients are included in the study according to inclusion and exclusion criteria.Then ،they will be randomly divided into two treatment and control groups. Randomisation is done using a random number table، stratification by age (in the two age groups below A-50 and B-50 years and older )and disease classes 1،2 and 3 are based on GOLD criteria and patients will be divided into two groups based on 4 or 6 blocks.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The capsules will be encoded by the individual as coders in two envelopes A and B.Patients will not be aware of the code allocation to the capsule envelope.Also،the researcher who provides the capsules to the clinic and the data analyst will not be aware of contents of the envelope and the allocation of patients to the treatment and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
Khorammabad
Province
Lorestan
Postal code
381351698
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.LUMS.REC.1399.044
Health conditions studied
1
Description of health condition studied
COPD
ICD-10 code
J44
ICD-10 code description
other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Cognitive function
Timepoint
Before starting treatment and one week after completing the 60 day treatment period
Method of measurement
Montreal Cognitive Dysfunction Questionnaire
2
Description
Pulmonary function
Timepoint
Before starting treatment and one week after completing the 60 day treatment period
Method of measurement
Spirometry device
3
Description
Activity daily of living
Timepoint
Before starting treatment and one week after completing the 60 day treatment period
Method of measurement
Lawton and London Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group،60 capsules of rosemary extract with a dose of 500 mg twice at 7 to 9 in the morning and maintaining a distance of 12 hours،again at 19 to 21 at night،one to two hours before breakfast or dinner and they will be consumed by patients with a glass of water.this drug is prepared by Goldaro Pharmaceutical Company located in Isfahan and is weighed and packaged in a sterile environment inside 500 mg capsules by the expert of Khorman Daru Khorramabad Company.
Category
Other
2
Description
Control group: In this group،60 capsules of Placebo (containing corn flour) with a dose of 500 mg twice at 7 to 9 in the morning and maintaining a distance of 12 hours،again at 19 to 21 at night،one to two hours before breakfast or dinner and they will be consumed by patients with a glass of water.the placebo is prepared and weighed by Khoraman Daroo Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahimi Hospital Specialized Clinic
Full name of responsible person
َArash momeni safarabadi
Street address
Khoramabad-Razi Square-Alley Arasteh One
City
Khoramabad
Province
Lorestan
Postal code
68168-64716
Phone
+98 66 3255 5012
Email
Arashmomeni1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Morovat Taheri Kalani
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran
City
Khoramabad
Province
Lorestan
Postal code
381251698
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
research@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Khorramabad University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arash momeni safarabadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khorramabad-Razi Square-Alley Arasteh One
City
Khorramabad
Province
Lorestan
Postal code
6816864716
Phone
+98 66 3255 5012
Email
arashmomeni1373@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medica
City
Khorammabad
Province
Lorestan
Postal code
6814993165
Phone
+98 912 509 1279
Fax
+98 66 3312 0139
Email
gholami.m@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Arash momeni safarabadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Khorramabad-Razi Square-Alley Arasteh one
City
Khorramabad
Province
Lorestan
Postal code
6816864716
Phone
+98 66 3255 5012
Email
arashmomeni1373@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available