Determining the effect of Horse Chestnut seed extract spray on improving and reducing the symptoms of sleep apnea
Design
Phase 2 clinical trial on 40 patients with sleep apnea in Razi Hospital
Settings and conduct
This clinical trial will be performed on 40 patients over 18 years with sleep apnea in Razi Hospital at Birjand. Patients will receive inhalation of Horse Chestnut seed extract intranasally as one puff in each nostril every 8 hours for 14 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Sleep disorder, Nocturnal snoring, Daily fatigue, Uncontrolled blood pressure, Pittsburgh Sleep Quality Index≥6;
Exclusion criteria:
Patients with a history of liver and kidney disease, Pregnant and lactating women, Children under 18 years old, Anticoagulant consumption and continuous use of aspirin, Having a cardiac pacemaker, History of allergy to any chemical, herbal, or medicinal compound, Patients with a history of taking various narcotic and psychoactive drugs
Intervention groups
Intervention group: Inhalation of one puff of Horse Chestnut seed extract spray every 8 hours inside each nostril for 14 days (Preparation of extract in Faculty of Pharmacy of Birjand)
Main outcome variables
Pittsburgh Sleep Quality Index, Adverse effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201228049868N3
Registration date:2022-09-05, 1401/06/14
Registration timing:prospective
Last update:2022-09-05, 1401/06/14
Update count:0
Registration date
2022-09-05, 1401/06/14
Registrant information
Name
Seyyed Mohammad Mousavi Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3162 6020
Email address
mousavim903@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-11, 1401/06/20
Expected recruitment end date
2022-11-11, 1401/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Horse Chestnut seed extract spray on improving and reducing the symptoms of sleep apnea
Public title
Evaluation of the effect of Horse Chestnut seed extract spray on sleep apnea
Patients with a history of liver and kidney disease
Pregnant and lactating women
Children under 18 years old
Anticoagulant consumption and continuous use of aspirin
Having a cardiac pacemaker
History of allergy to any chemical, herbal, or medicinal compound
Patients with a history of taking various narcotic and psychoactive drugs
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Ministry of Defence and Armed Forces Logistics
Street address
Shahid Langari St., Nobonyad Square., Pasdaran St
City
Tehran
Province
Tehran
Postal code
1693715817
Approval date
2021-11-11, 1400/08/20
Ethics committee reference number
IR.CHAMRANHOSPITAL.REC.1400.007
Health conditions studied
1
Description of health condition studied
Sleep apnea
ICD-10 code
G47.3
ICD-10 code description
Sleep apnea
Primary outcomes
1
Description
Pittsburgh Sleep Quality Index
Timepoint
Before the intervention and 14 days after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Adverse effects
Timepoint
14 days after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Inhalation of one puff of Horse Chestnut seed extract spray every 8 hours inside each nostril for 14 days (Preparation of extract in Faculty of Pharmacy of Birjand)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6000
Email
mousavim903@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Reza Miri
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Position
Assistant professer
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6000
Email
mousavim903@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6000
Email
mousavim903@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Mousavi Mirzaei
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Razi Hospital, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717844471
Phone
+98 56 3162 6000
Email
mousavim903@bums.ac.ir
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