Assessment of the effect of nano-curcumin oral intake on clinical signs and serum IL-6 levels in patients with ischemic stroke: Double-blind Clinical Trial
The effect of nano curcumin treatment on clinical symptoms and serum level of inflammatory factor IL-6 in patients with ischemic cerebral stroke.
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
Forty patients referred to the neurology department of Poursina Hospital in Rasht with ischemic stroke symptoms confirmed by CT-Scan. Then patients were randomly divided into two groups of 20 nanocurcumin and control and into Four-person blocks . This was done by Ms. Samaneh Shirkoohi (patients, assessors and physicians did not know the individuals in each group). The curcumin group will receive a single 80 mg capsule of nano-micelles of curcumin daily (Cina Curcumin ®, Exir Nano Sina Co.) for one month, and the control group will receive curcumin placebo for 1 month. All patients will be monitored for one month.Blood samples will be taken before and after the end of treatment for one month. The blood factor IL-6 will be measured using ELISA kit in both curcumin and placebo groups. The data will be analyzed as per protocol.
Participants/Inclusion and exclusion criteria
inclusion: Patients with ischemic stroke less than a week after their stroke with NIHSS <=20 and MRS<=4
exclusion: Cerebral Venous Thrombosis
Hemorrhagic infarction
Intervention groups
The curcumin group will receive a single 80 mg capsule of nano-micelles of curcumin daily (Sina Curcumin ®, Exir Nano Sina Co.) for 1 month, and Control group will receive curcumin placebo (capsule containing 80 polycarbate produced by Exir Nanosina) for 1 month.
Main outcome variables
The National Institute of Health Stroke Scale (NIHSS) questionnaire
The blood level of Inflammatory factor IL-6
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091108002680N3
Registration date:2020-02-24, 1398/12/05
Registration timing:prospective
Last update:2020-02-24, 1398/12/05
Update count:0
Registration date
2020-02-24, 1398/12/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
0131-3227346
Email address
a_saberi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of nano-curcumin oral intake on clinical signs and serum IL-6 levels in patients with ischemic stroke: Double-blind Clinical Trial
Public title
Assessment of the effect of nano-curcumin oral intake on clinical signs and serum IL-6 levels in patients with ischemic stroke: Double-blind Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ischemic CVA less than 1 week from their symptoms begin
National Institutes of Health Stroke Scale (NIHSS) <= 20
Modified Rankin Scale (MRS) <= 4
Exclusion criteria:
Cerebral Venous Thrombosis
Hemorrhagic infarction
Internal capsule and Middle Cerebral Artery trunk infarction
History of gall bladder stone or bile duct stenosis
Gastroesophageal reflux disease or active peptic ulcer
Use of NSAIDs or Reserpine
Using anticoagulant or thrombolitic agent in last 24 hours
Using of Warfarin in last 1 week
Dissatisfaction
More than 1 week from symptoms begin
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization is used for randomization.The blocks are fixed and 4 in size that the first 2 will be in the curcumin group and the second 2 will be in the placebo group
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals under study, physicians and those assessing outcomes are kept blind to specific study groups.
After selecting patients, medications are given to patients in unnamed and similar envelopes by Ms. Samaneh Shirkoohi, and the list of patients in each group will not be disclosed until the end of the data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of gilan University of Medical Sciences
Street address
Neuroscience Research Center, Pursina Hospital, Nursing Street
City
rasht
Province
Guilan
Postal code
41937-13194
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.GUMS.REC.1398.222
Health conditions studied
1
Description of health condition studied
Ischemic cerebral stroke
ICD-10 code
I64
ICD-10 code description
Stroke, non specified as haemorrhage or infarction