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Explanation of cerebrovascular attack (CVA) based on Iranian traditional medicine (ITM) and evaluation of clinical trial an ITM – based protocol and modern medical- based protocol on clinical improvement of CVA

Protocol summary

Summary
The main purpose of the project was to investigate the role of stroke in persian medicine and the effect of therapy on the course of treatment . In fact, the present qualitative research was based on Clinical Trial. First, the materials are collected, and then the basics of stroke were discussed. Subsequently, in the phase of clinical trial, the patients were admitted to the neurology department of Ghaem Hospital, Mashhad, Iran, based on their clinical examination and CT brain scan diagnosis of CVA. A comprehensive questionnaire was given to each patient on admission, and their consent was obtained. All the moral principles were established to the patients. The patients participating in the project were matched at baseline. In addition, they were randomly assigned to intervention and control groups. The control group was given the modern medicine package, and the intervention group received the traditional medicine package. The current study was a randomized, double-blind treatment. Throughout the hospitalization period, the exprts visited the patients every day and the whole treatment was under their careful supervision.

General information

Acronym
CVA:cerebro vascular attack
IRCT registration information
IRCT registration number: IRCT2015122025622N1
Registration date: 2016-05-29, 1395/03/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Elahe Delshad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3732 7620
Email address
delshade911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-11-06, 1396/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Explanation of cerebrovascular attack (CVA) based on Iranian traditional medicine (ITM) and evaluation of clinical trial an ITM – based protocol and modern medical- based protocol on clinical improvement of CVA
Public title
evaluation of an ITM – based protocol on clinical improvement of CVA
Purpose
Treatment
Inclusion/Exclusion criteria
In our study, the inclusion criteria encompassed patients whom were discovered to have focal neurological symptoms after their brain imaging, being diagnosed with ischemic CVA. On the other hand, the exclusion criteria were as follows: 1. patients with focal neurological findings ith regard to the candidate symptoms of venous rTPA; 2. patients with symptoms in less than 24 hours of a TIA with normal imaging raises; 3. patients on admission with NIHSS Score and analytically based on a bad prognosis. 4. patients with chronic systemic diseases such as uremia, chronic liver disease, and high blood pressure a potential impact would be on our protocol and our intervention would accelerate HIV disease; 6. patients with possible teratogenic effects of safflower pregnancy; 7. patients having any evidence of brain hemorrhage; 8. patients receiving anticoagulant (heparin or warfarin); 9. incidence of venous infarcts in venous sinus thrombosis; 10. patients reluctant to continue double-blind treatment. During hospitalization, the patients were visited on a daily basis by experts who closely supervised the treatment.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this randomized study is done based on random numbers table.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreshi department, Avenue Daneshgah, Mashhad
City
Mashhad
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.MUMS.REC.1394.555

Health conditions studied

1

Description of health condition studied
Ischemic cerebro vascular attack
ICD-10 code
G46.4*
ICD-10 code description
cerebro vascular syndrom

Primary outcomes

1

Description
Score of disability based on Questionnaire NIHSS
Timepoint
Baseline and one month after presentation
Method of measurement
Clinical examination by an expert on the NIHSS score

Secondary outcomes

1

Description
Biochemical markers
Timepoint
Baseline and one month after the initial visit
Method of measurement
blood test

Intervention groups

1

Description
The intervention group, in addition to the current anti-ischemic drugs, ITM, based protocol will be prescribed. - Traditional Therapy package includes an oral syrup safflower extract and safflower oil is a nasal drop. Venice is a barley soup (including barley, celery, prune, tamarind, candy and a little salt and turmeric) is included in the patient's diet - dose nasal drops 3 drops in each nostril every 4 hours Mybashd.bh a month - barley soup In the first two weeks the patient will be referred to the main course. A 100 ml bottle of safflower syrup prepared with a concentration of 25% by volume weight twice daily to patients is recommended every 5 ml of the syrup mill. For a month
Category
Treatment - Drugs

2

Description
Routin anti-ischemic drugs plus a placebo given to the control group. Current treatments include aspirin 325 mg daily, and 20 mg Trvstatyn and, if not above the patient's creatinine is 30 cc daily Piracetam. Inert placebo form of the drug is similar to the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Guaem hospital of Mashhad University of Medical Sciences
Full name of responsible person
Delshad Elahe
Street address
Guaem hospital, Ahmadabad Avenue
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Eslami
Street address
Ghoreshi departman, Daneshgah Avenue
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Delshad Elahe
Position
Phd student of Traditional Medicin
Other areas of specialty/work
Street address
opposite the Mehran sports hall, East Razi Street, Dahe day Square
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
+98 51 3853 5980
Email
delshade911@mums.ac.ir
Web page address
http://tim.mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Delshad Elahe
Position
Phd student of Traditional Medicine
Other areas of specialty/work
Street address
opposite of the Mehran sports hall, East Razi Street, dahe day Square
City
Mashhad
Postal code
Phone
+98 51 3732 7620
Fax
+98 51 3853 5980
Email
delshade911@mums.ac.ir
Web page address
http://tim.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Delshad Elahe
Position
Phd student of Traditional Medicine
Other areas of specialty/work
Street address
No 30, Motahari shomali No 30 Avenue
City
Mashhad
Postal code
9194915843
Phone
+98 51 3732 7620
Fax
+98 51337327620
Email
delshade911@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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