The effect of Ocimum Hydro Alcoholic Extract on Cognitive Function and Sleep Quality in patients with Choronic Obstructive Pulmonary Disease: A randomized controlled clinical trial
The effect of basil extract on cognitive function and sleep quality of patients with chronic obstructive pulmonary disease
Design
Clinical trial with control group, with parallel groups, Triple blind, Randomized controlled trial
Settings and conduct
The intervention will be administration of basil and placebo extract for eight weeks (60 days).The study place is in Khorramabad city.
Participants/Inclusion and exclusion criteria
1) Male and female patients 40 to 80 years old and residing in Khorramabad city
2) Sleep disorder score above 5 (based on Pittsburgh Sleep Disorders Questionnaire)
3) Cognitive dysfunction score below 26 (based on Montreal Cognitive Impairment Questionnaire);
1) Patient worsening, unstable hemodynamic status, life-threatening arrhythmias
2) neurodegenerative diseases, cancer, acute infection and known mental disorders (anxiety, depression and delirium)
3) Need for sleep medications (such as benzodiazepines, etc.) during the study
Intervention groups
The capsules will be packed in 60 envelopes at a dose of 300 mg in two envelopes A and B and delivered to the two groups of patients at the lung clinic. The capsules (containing basil and placebo extract) will be taken by patients once a night, between 22-21pm, one to two hours before bedtime, and with a glass of water.
Main outcome variables
Cognitive performance score based on Montreal questionnaire; Sleep quality score based on Pittsburgh questionnaire, And he is in the specialized clinic of Shahid Rahimi Hospital.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150919024080N15
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
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
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ocimum Hydro Alcoholic Extract on Cognitive Function and Sleep Quality in patients with Choronic Obstructive Pulmonary Disease: A randomized controlled clinical trial
Public title
The effect of Ocimum on sleep and cognitive function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients 40 to 80 years old and residing in Khorramabad city
Sleep disorder with a high score of 5 (based on Pittsburgh Sleep Disorder Questionnaire)
Cognitive dysfunction score below 26 (based on Montreal Cognitive Impairment Questionnaire)
No history of allergy to ocimum extract
Minimum literacy and ability to understand Persian language
Exclusion criteria:
Illness, unstable hemodynamic status, life-threatening arrhythmias
Affected by neurological diseases, cancer, acute infection and known mental disorders (anxiety, depression and delirium)
The need for sleep medications (such as benzodiazepines, etc.) during the study
Hospitalization during the study
Participate in other Nairobi yoga and meditation cardiopulmonary rehabilitation programs
Sensitivity to ocimum Extract for 2 consecutive days during study and non-use of ocimum Extract Capsule
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
96
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. Classification is done using a random number table. Classes by age (in the two age groups below A-50 and B-50 years and older) and literacy (A-read literacy has no web-literacy) It should be noted that the volume of each block is 4 cases, thus creating 6 different combinations of 4 blocks and randomly selecting the 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 the 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
Iran University of Medical Sciences, Lorestan, Khorram Abad, 5 Km.
City
Khorram Abad
Province
Lorestan
Postal code
381351698
Approval date
2019-09-28, 1398/07/06
Ethics committee reference number
IR.LUMS.REC.1398.163
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
Cognitive performance score
Timepoint
Before the intervention, and one week after the 60-day treatment period
Method of measurement
Montreal Cognitive Impairment Questionnaire
2
Description
Quality of sleep score
Timepoint
Before the intervention, and one week after the 60-day treatment period
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, 60 basil capsules will be taken by patients at a dose of 300 mg once daily at 22-22 hours, one to two hours before bedtime, and with a glass of water.The drug was developed at the Razi Plant Research Center under the supervision of Lorestan University of Medical Sciences.
Category
Other
2
Description
Control group: In this group, placebo capsules (containing corn flour) will be administered by 60 patients at a dose of 300 mg once a night between 22-21pm, one to two hours before bedtime, and with a glass of water by patients.The placebo was built at the Razi Plant Research Center under the supervision of Lorestan University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialty Clinic of Shahid Rahimi Hospital
Full name of responsible person
Seyed Reza Hosseini Fard
Street address
Khorramabad - Freedom Square - Mojahedin Street
City
Khorramabad
Province
Lorestan
Postal code
6814713115
Phone
+98 66 3341 9123
Email
reza.hfard@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Falahi
Street address
km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahrizak village- Integrated Lorestan Medical Sciences Khoramabad, Lorestan, Iran