Evaluation the effect of Thyme and Lavandula angustifoliaon for Treatment and Control of high Altitude Disease
Design
randomized controlled clinical trial
Settings and conduct
This study is a randomized clinical trial on climbers in Tehran and Karaj diagnosed with altitude sickness in 2020-2021. thirty climbers will be included in the study based on inclusion and exclusion criteria .Inclusion criteria includes: age between 18 -30, residency at the high altitude of 3000m -3500m for 48 hours and altitude sickness diagnosis.
Participants/Inclusion and exclusion criteria
Some climbers of Tehran and Karaj which are suffering from altitude disease
Intervention groups
Some climbers of Tehran and Karaj which are suffering from altitude disease in Intervention group herbal syrups are going to be prescribed as following: Lavandula angustifolia at the dose of 10000 mg twice a day is going to be prescribed within the 48 hours (produced by Alis company). So as to prescribe Thymus, Thymus vulgaris is going to be prescribed at the dose of 10 mL three times a day within the 48 hours (produced by Kimiagar company). both herbal drugs are going to be prescribed based on drug manufacturer instruction.
in control group patients received Acetazolamide at the dose of 500 mg twice a day.
Evaluation of the effects of thyme and lavendula angustofuLian for treatment and control of high altitude mountain sickness in climbers
Public title
Thyme and lavandula angustifolian in treatment of acute mountain sickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute mountain sickness and altitude disease suffering
Camping at the high altitude of 3000m - 3500m from see level for 48 hours
Age betwean 18-40 years old
Consent to participate in the study
Exclusion criteria:
Vital sign instability
Heart rate abnormality
High or low blood pressure
High respiratory rate
Decrease of axillary temperature
Decrease of artrial oxygen saturation
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated into the case and control groups using permuted balance block randomization. The blocks are four. Using STATA software, random numbers are generated from 1 to 6. Another number is generated when the previous number is more than 6, without considering it. An individual prepare the random numbers and put them in pockets with a five-digit serial number. All pockets open after including a patient, and the patient allocates to a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of alborz medical university
Street address
N 67 taeghani north
City
Karaj
Province
Alborz
Postal code
۳۱۳۳۹۷۵۵۴۶
Approval date
2020-10-14, 1399/07/23
Ethics committee reference number
IR.ABZUMS.REC.1399.181
Health conditions studied
1
Description of health condition studied
acute moution sickness
ICD-10 code
T70.2
ICD-10 code description
Other and unspecified effects of high altitude
Primary outcomes
1
Description
heart rate
Timepoint
each 6 hour within the 48 hours
Method of measurement
pulse oximeter
2
Description
respiratory rate
Timepoint
each 6 hour within the 48 hours
Method of measurement
counting respiratory rate in a minute
3
Description
blood pressure
Timepoint
each 6 hour within the 48 hours
Method of measurement
Automatic blood pressure monitors
4
Description
axillary temprature
Timepoint
each 6 hour within the 48 hours
Method of measurement
Thermometer
5
Description
artrial oxygen saturation
Timepoint
each 6 hour within the 48 hours
Method of measurement
pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: prescription of herbal syrups: Lavandula angustifolia at the dose of 10000 mg twice a day is going to be prescribed within the 48 hours (produced by Alis company). So as to prescribe Thymus, Thymus vulgaris is going to be prescribed at the dose of 10 mL three times a day within the 48 hours (produced by Kimiagar company). both herbal drugs are going to be prescribed based on drug manufacturer instruction.
Category
Treatment - Drugs
2
Description
Control group: Acetazolamide is going to be prescribed at the dose of 500 mg twice a day within 48 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid raises hospital
Full name of responsible person
Dr sahar chobtashani
Street address
No 3, almandine ,Shahid begeshti , karaj
City
Karaj
Province
Alborz
Postal code
۳۱۳۳۳۹۵۷۶۷۸
Phone
+98 26 3445 6783
Email
Saharchobtashani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr sahar chobtashani
Street address
No 120, taleghani, Karaj
City
Karaj
Province
Alborz
Postal code
۳۱۳۳۹۲۵۵۴۵
Phone
+98 26 3222 5678
Email
Saharchobtashani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj University of Medical Sciences
Proportion provided by this source
1
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
Karaj University of Medical Sciences
Full name of responsible person
Dr sahar chobtashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 87 , shahid tahmasebi , taleghani , karaj
City
Karaj
Province
Alborz
Postal code
۳۳۳۹۷۵۵۴۶
Phone
+98 21 2256 2378
Email
Saharchobtachani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Sahar chobtashani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 87, shahid tahmasebi , taleghani , karaj
City
Karaj
Province
Alborz
Postal code
۳۱۳۳۹۷۵۵۴۶
Phone
+98 21 2256 2378
Email
Saharchobtashani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr Mahmood bakhtiary
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
No 87, shahid tahmasebi, taleghani, karaj
City
Karaj
Province
Alborz
Postal code
۳۱۳۳۹۷۵۵۴۶
Phone
+98 21 2256 2378
Email
Rezabakhtiary@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because we didn’t finalized our data
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Acute mountain sickness herbal treatment
When the data will become available and for how long
1-14/2/2021
To whom data/document is available
College’s
Under which criteria data/document could be used
For control and treatment of ams
From where data/document is obtainable
Dr Mahmood Bakhtiyari
What processes are involved for a request to access data/document
E-mail correspondence to Dr Mahmood Bakhtiyari (mahmood.bakhtiyari@ymail.com ) will be responded approximately within a week.