Determination of the effect of Basil herbal preparation on sleep in patients with primary sleep disorder
Design
Control group: Group of placebo recipients (30 patients at the end of the study should be in this group.)
intervention group 1: First dose of preparation including 250 mg of Basil extract (30 patients at the end of the study should be in this group.)
intervention group 2: second dose of preparation including 500 mg of Basil extract (30 patients at the end of the study should be in this group.)
Settings and conduct
Making a capsule containing the steps: extraction, adding filler materials (lactulose). Hydro alcoholic extract of 70% of basil leaves is obtained by softening. The capsule is standardized according to the total phenol content.
This clinical trial will be performed on 90 patients aged 18 to 40 who suffer from a primary sleep disorder. Patients are randomly divided into three groups of 30, the first group receiving 1 capsule and the second group receiving 2 and the other group received placebo every week for 1 week. Sleep quality of both groups was measured by Pittsburgh standard sleep quality questionnaire before and after intervention.
Participants/Inclusion and exclusion criteria
Entry requirements:
Patient 18 to 40 years old
primary sleep disorders
No other mental illness
Intervention groups
Group 1: Placebo recipients.
Group 2: First dose of preparation including 250 mg of Basil extract recipients.
Group 3: The second dose of preparation including 500 mg of Basil extract recipients.
Main outcome variables
Sleep Quality According to the St. Petersburg Questionnaire
General information
Reason for update
Acronym
BMIS
IRCT registration information
IRCT registration number:IRCT20180103038199N1
Registration date:2018-05-04, 1397/02/14
Registration timing:registered_while_recruiting
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Vahid Reza Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2264
Email address
askariv941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-16, 1396/12/25
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of possible hypnotic impact of basil (Ocimum basilicum) made product on patient suffering from insomnia
Public title
Basil in insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primary sleep disorders
Willing to cooperate
Defined conditions of initial insomnia according to DSM-V for at least three months
Lack of illnesses such as pulmonary diseases, allergic rhinitis, heart disease, infectious diseases, cancers
Lake of Mental Illness: Like Depression
No neurological disease like Parkinson's, Alzheimer's
Lack of sleep disorders such as sleep apnea
Exclusion criteria:
Pregnant and lactating women
History of allergy to medicinal herbs
Unwillingness to continue cooperation for any reason
Age
From 18 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
35 cards or envelops are considered as the first group and the same number of cards for the next groups (the second and third groups of the intervention); then, by merging the cards, the card is withdrawn and the allocation is recorded. And that card will be returned to the other cards once it is exited. Then the cards are merged again and another card is dropped out. This process continues to reach a random sequence according to sample size. The ratio of the groups is 1: 1: 1.
Blinding (investigator's opinion)
Double blinded
Blinding description
Healthcare personnel, data collection authorities and those who evaluate the outcome, the Data Safety and Monitoring Committee, who are preparing the draft article, are completely uninformed about the recipient groups. It should be noted that the patient is aware of the clinical trial but does not know whether he is taking the placebo or the main drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical sciences ethical committee
Street address
Faculty medicine, Ferdowsi complex, َVakil Abad Blvd, Azadi Sq.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2017-05-06, 1396/02/16
Ethics committee reference number
IR.MUMS.REC.1396.21
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
F51.01
ICD-10 code description
Primary insomnia
Primary outcomes
1
Description
Changing the score in the Pittsburgh Questionnaire
Timepoint
Before the beginning of the study and at the end of the study
Method of measurement
Based on the Pittsburgh Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: receiving the same form of capsule prepared from basil extract with starch powder without basil in form of 500 mg unique shapes for all groups. It is noteworthy that these capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 1 week. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug.
Category
Placebo
2
Description
Intervention group 1: receiving the capsule at dose of 250 mg prepared from basil extract with starch powder in form of 500 mg unique shapes for all groups. It is noteworthy that these capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 1 week. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug.
Category
Treatment - Drugs
3
Description
Intervention group 2: receiving the capsule at dose of 500 mg prepared from basil extract with starch powder in form of 500 mg unique shapes for all groups. It is noteworthy that these capsules are made at the Mashhad Medical Sciences University and at the Pharmacological Research Center of Medicinal Plants. The capsules administrate one dosage every night for 1 week. Also, the patient is told to promptly inform the investigators if certain symptoms indicating the side effects of the drug or the sensitivity to the drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital; Mashhad University of Medical Sciences
Full name of responsible person
Dr Hassan Rakhshandeh
Street address
Horre Ameli Avenue, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
Rakhshandehh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology of the University (Mohsen Taaghodi)
Street address
Faculty of Medicine, Azadi sq, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 8566
Email
Rakhshandehh@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hassan Rakhshandeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Azadi sq, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 915 503 6929
Email
Rakhshandehh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hassan Rakhshandeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Medicine, Azadi sq, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 915 503 6929
Email
Rakhshandehh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Reza Askari
Position
PhD student of clinical pharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of medicine, Paradise of University, Vakil-Abad Blvd., Azadi Sq., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2264
Fax
Email
askariv941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Access to research documentation includes randomization, drug delivery and clinical application
When the data will become available and for how long
After the study is completed and the data analysis, as well as the publication of its article, will allow access to the data.
To whom data/document is available
Those who are only authorized to access data are introduced by the vice chancellor for research at the University of Mashhad or Iran's Ministry of Health.
Under which criteria data/document could be used
The applicant will submit his request to the vice chancellor for research at Mashhad University of Medical Sciences, and will be provided with the consent of the vice chancellor and the ethics committee.
From where data/document is obtainable
Deputy of Research of Mashhad University of Medical Sciences
Vcresearch@mums.ac.ir
Head of Pharmacological Research Center of Medicinal Plants
PRMP@mums.ac.ir
What processes are involved for a request to access data/document
The approval of the university research vice and the ethics committee must be followed.