The effect of Dorema ammoniacum and acupuncture on the clinical improvement of patients with cerebral stroke
Design
In this study, 57 patients with ischemic stroke and inclusion criteria of the study who are referred to Ghaem Hospital in Mashhad are selected. Patients are randomly assigned into three categories by using Random number table.
Settings and conduct
Patients with ischemic stroke referred to Mashhad Ghaem Hospital are examined by neurologist and if they have inclusion criteria, they will enter the study after obtaining written informed consent.
Participants/Inclusion and exclusion criteria
Major inclusion criteria of the study is ischemic stroke in the past 30 days؛ major condition for not entering the study is the presence of hemorrhagic stroke.
Intervention groups
All groups receive standard treatment and physiotherapy. People in the first group receive one gram of Dorema ammoniacum gum and patients in group 2 receive acupuncture. The third group is control group and receives only standard treatment and physiotherapy.
Main outcome variables
Disability due to cerebral stroke (modified NIHSS standard questionnaire and modified Rankin scale standard questionnaire) ؛
Aspartate aminotransferase ؛
Low density lipoprotein ؛
High density lipoprotein ؛
Alanine aminotransferase ؛
Blood urea nitrogen ؛
Glycosylated hemoglobin ؛
Triglyceride ؛
Complete Blood Count ؛
Fasting blood sugar ؛
Creatinine ؛
Partial thromboplastin time ؛
Prothrombin Time ؛
International Normalized Ratio (INR) ؛
Cholesterol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170227032797N2
Registration date:2018-03-05, 1396/12/14
Registration timing:registered_while_recruiting
Last update:2018-03-05, 1396/12/14
Update count:0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9279
Email address
mehrpourm911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dorema ammoniacum and acupuncture on the clinical improvement of patients with cerebral stroke
Public title
Effect of Dorema ammoniacum and acupuncture in treatment of cerebral stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with focal neurological findings that have been clinically and with brain imaging have been diagnosed with ischemic stroke
Ischemia is in the superior branch of middle cerebral artery
Stroke attack in less than thirty days
Age between 50 and 75 years
First stroke attack
Modified NIHSS between 4 and 20
Patient with consciousness and stable disease condition
Exclusion criteria:
Cerebral stroke of hemorrhagic type
Patients suffering from systemic chronic diseases such as: uncontrolled diabetes, severe liver, cardiac, renal or pulmonary disorders or cancer
Patients taking coagulants (heparin or warfarin)
Patients with BMI above 35
Patients with history of acupuncture in less than a month
Patients with a history of allergy to Dorema Ammoniacum
Patient suffering from severe musculoskeletal or neurologic diseases before ischemic stroke
Patients diagnosed with tumor or skin infections
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned into three categories: A, B, and C using Random number table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ethics committee of Mashhad University of Medical Sciences, Quraishi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
۳۴۵ - ۹۱۳۷۵
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
IR.MUMS.REC.1395.518
Health conditions studied
1
Description of health condition studied
Cerebral infarction
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Disability due to cerebral stroke
Timepoint
Before the intervention, After the end of the intervention
Method of measurement
MNIHSS and mRankin scales
Secondary outcomes
1
Description
Aspartate aminotransferase
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
2
Description
Low density lipoprotein
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
3
Description
High density lipoprotein
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
4
Description
Alanine aminotransferase
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
5
Description
Blood urea nitrogen
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
6
Description
Glycosylated hemoglobin
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
7
Description
Triglyceride
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
8
Description
Complete Blood Count
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
9
Description
Fasting blood sugar
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
10
Description
Creatinine
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
11
Description
Partial thromboplastin time
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
12
Description
Prothrombin Time
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
13
Description
International Normalized Ratio (INR)
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
14
Description
Cholesterol
Timepoint
before intervention and after the end of intervention
Method of measurement
blood test
Intervention groups
1
Description
Intervention group: In the first intervention group, standardized treatment and physiotherapy, and also Dorema ammoniacum gum with a daily dose of one gram is given as an oral capsule, twice a day for one month.
Category
Treatment - Drugs
2
Description
Intervention group: The second intervention group receives the standard treatment and physiotherapy and also acupuncture treatment provided by an acupuncturist. The number of acupuncture sessions is twelve 30 minute sessions, three times a week.
Category
Treatment - Drugs
3
Description
Control group: In the control group, standard treatment and physiotherapy are received.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurology, Ghaem Hospital
Full name of responsible person
Dr. Kavian Ghandehari
Street address
Ghaem Hospital, Ghaem Educational and Research and Therapeutic Center, Ahmad Abad Ave., Dr Shariati Square (Taghi Abad)
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0001
Email
GhandehariK@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice Chancellor for Research of Medical University of Mashhad, Qaryashi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91375-345
Phone
+98 51 3841 1538
Email
Vcresearch@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
Mahsa Mehrpour
Position
Persian Traditional Medicine Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine and Supplement, Mashhad University of Medical Sciences, Ferdowsi University, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
00985138848931
Phone
+98 51 3884 8931
Email
mehrpourm911@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Bahrami Taghanaki
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine and Supplement, Mashhad University of Medical Sciences, Ferdowsi University, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
917794-8564
Phone
+98 51 3884 8931
Email
bahramihr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Mehrpour
Position
Persian Traditional Medicine Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine and Supplement, Mashhad University of Medical Sciences, Ferdowsi University, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
917794-8564
Phone
+98 51 3884 8931
Email
mehrpourm911@mums.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