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Efficacy and Safety of nano-curcumin on the clinical condition of patients with hemorrhagic stroke: A randomized, assessor-blind, parallel-group pilot study

Protocol summary

Study aim
Efficacy and Safety of nano-curcumin on the clinical condition of patients with hemorrhagic stroke
Design
A randomized, assessor-blind, parallel-group pilot study. Phase 2 is performed on 40 patients with hemorrhagic stroke who are divided into two groups. The intervention group (20 patients) in addition to the main treatment of hemorrhagic stroke, receive nano-curcumin 80 mg daily and the control group (20 patients) receive only their main treatment. Excel software rand function was used for randomization.
Settings and conduct
Within 24 hours after the start of ICH, the control group will receive their routine treatments and the intervention group, in addition to routine and standard treatments, will be prescribed 80 mg curcumin capsules and will continue to 12 weeks. Place of study: Bu Ali Hospital in Sari ciry
Participants/Inclusion and exclusion criteria
Age 80-18 years, diagnosis of ICH with CT scan of the brain, NIHSS> 4 and MRS <2 presympomatic, bleeding in the putamen area, Glasgow criterion (GCS greater than 8) and informed consent of the patient or first-degree relatives. Allergy to turmeric, no pregnancy, no liver enzymes more than three times of normal range and kidney disease or creatinine more than 2, no candidate for surgery and hematoma evacuation, no secondary ICH to anticoagulants and tumor and aneurysm and AVM, no infratentorial bleeding, Platelet count <75,000 / mm3, INR <1.4,
Intervention groups
Intervention group: Routine treatment in addition to nanocurcumin 80 mg daily. Control group: Routine treatment.
Main outcome variables
Disability and dysfunction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140221016666N4
Registration date: 2020-11-30, 1399/09/10
Registration timing: prospective

Last update: 2020-11-30, 1399/09/10
Update count: 0
Registration date
2020-11-30, 1399/09/10
Registrant information
Name
Narges Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 6275
Email address
n.karimi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and Safety of nano-curcumin on the clinical condition of patients with hemorrhagic stroke: A randomized, assessor-blind, parallel-group pilot study
Public title
Efficacy and safety of nano-curcumin on the clinical condition of patients with hemorrhagic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-80 years, Diagnosis of ICH by brain CT scan, NIHSS> 4 and MRS <2 presymptomatic, bleeding in the putamen area, Glasgow criterion (GCS greater than 8) informed consent of the patient or first-degree relatives.
Exclusion criteria:
Allergy to turmeric, pregnancy, liver disease with liver enzyme more than three times of normal range kidney disease or creatine more than 2, candidate for surgery and hematoma evacuation, secondary ICH for anticoagulant use and tumor and aneurysm and AVM, infratentorial hemorrhage, platelet count / 75,000 mm3 <, INR <1.4, fever at initial visit, other inflammatory diseases including pneumonia, hematology, rheumatology, urinary tract infection on admission. Immune suppressant drugs,] absorption syndromes, history of diabetes, smoking, alcohol and drug use
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Random sample selection is based on block balance randomization with 4 blocks. The intervention and control groups are named A and B so that from the four blocks that will be shown in 6 states (AABB, BBAA, ABAB, BABA, ABBA, BAAB and using the table of random numbers, the row of blocks will be selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician evaluating the patient will be blind. In this study, the physician who gives the medicine to the patients and the patients or participants are not blind and know the type of treatment but the assessors who examine patients and complete the questionnaire are blind and do not know the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem squre, Sari City
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.MAZUMS.REC.1399.718

Health conditions studied

1

Description of health condition studied
Intracerebral hemorrhage
ICD-10 code
I61
ICD-10 code description
Nontraumatic intracerebral hemorrhage

Primary outcomes

1

Description
Improvement of the patient's disability and dysfunction to achieve MRS is below 3
Timepoint
At the time of admission, 24, 48 and 72 hours, 1 week (or last day of hospitalization), 4 weeks and 12 weeks
Method of measurement
MRS questionnaire

Secondary outcomes

1

Description
Reduce NIHSS to less than the initial 50% and reduce hematoma volume and increase Glasgow score
Timepoint
At the time of admission, 24, 48 and 72 hours, 1 week (or last day of hospitalization), 4 weeks and 12 weeks
Method of measurement
Hematoma size is measured using the formula ABC / 2 (A: The largest diameter in the largest bleeding slice, B the diameter perpendicular to A and C, the approximate number of 10 mm slices in which bleeding occurs). NIHSS Questionnaire and Glasgow scale

Intervention groups

1

Description
Intervention group: Nano-curcumin medication with dosage of 80 mg for 12 weeks
Category
Treatment - Drugs

2

Description
Control group: Patients with cerebral hemorrhage without medication
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
‌Bou ali Sina hospital
Full name of responsible person
Narges Karimi
Street address
Bou ali Sina hospital, Pasradan Boulevard, Sari city
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3311 6275
Email
Drkarimi_236@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology
Street address
Sari, Moallem Square, Deputy of Research and Technology
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3325 7230
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Karimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Mirjani street, Bagh Sang, Sari City
City
Sari
Province
Mazandaran
Postal code
4818734619
Phone
+98 11 3311 6275
Email
drkarimi_236@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Karimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Mirjani street, Bagh Sang, Sari city
City
Sari
Province
Mazandaran
Postal code
4818734619
Phone
+98 11 3311 6275
Email
drkarimi_236@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Narges Karimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Mirjani street, Bagh Sang, Sari city
City
Sari
Province
Mazandaran
Postal code
4818734619
Phone
+98 11 3311 6275
Email
drkarimi_236@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
At the request of a scientific and academic reference
From where data/document is obtainable
Narges Karimi, Drkarimi_236@yahoo.com
What processes are involved for a request to access data/document
By accepting the University Ethics Committee, data can be provided
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