Protocol summary

Study aim
Determination of the effect of curcumin on serum lipoprotein(a) and hs-CRP levels in diabetic type 2 patients with coronary artery disease with an obstruction angiography of less than 50%
Design
Pragmatic, community based, parallel group, double blind, randomised controlled trial
Settings and conduct
Of the patients referred to the heart department of Ghaem Hospital, 82 patients were diagnosed with mild to moderate coronary artery disease (coronary artery stenosis less than 50%) based on their angiographic findings and at the same time had type 2 diabetes.These patients were randomly divided into two groups. They were treated with sinacurcamine 80 mg / day in the form of a 80 mg capsule or placebo for 3 months, plus a routine regimen with similar standard drugs. In the laboratory of the Ghaem Hospital, 15 ml blood samples were taken from brachialis vein of patients, for examination of the biochemical tests at the beginning and three months after starting the drug treatment and then transferred to the -80 degree freezer of the medical school. The level of biomarkers was then measured.
Participants/Inclusion and exclusion criteria
Diabetic patients with type 2 diabetes mellitus, with mild to moderate coronary artery disease confirmed by angiography, candidated for standard drug treatment. People with less than 18 years of age, liver disease, pregnancy, obstructive coronary artery disease requiring revascularisation, hsCRP levels above 8, clopidogrel consumption, inflammatory and infectious diseases, immunosuppressive drugs, and acute myocardial infarction were excluded.
Intervention groups
prescription of sinacurcumin for case group and placebo in the same shape and size of curcumin capsules to control group
Main outcome variables
Main outcome variables include: hs-CRP and LP(a) and HDL, LDL, TC and TG serum level.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130811014330N4
Registration date: 2018-10-30, 1397/08/08
Registration timing: retrospective

Last update: 2018-10-30, 1397/08/08
Update count: 0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Hamid Reza Rahimi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1800 2288
Email address
rahimihr891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Curcumin on serum level changes of lipoprotein (a) and hs-CRP as novel biomarkers in type 2 diabetic patients with coronary artery disease of less than 50% obstruction: A double-blind clinical trial study
Public title
The effect of Curcumin on LP(a) and hs-CRP in diabetes patients and concurrent coronary artery diseases( coronary artery disease less than 50% obstruction)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with coronary artery disease which were selected by cardiologist Male/ Female older than 18 years diabetic patients Coronary artery stenosis in angiography less than 50%
Exclusion criteria:
Pregnant and breast-feeding patients; Rheumatic disease; Chronic liver diseases; Renal diseases; Every types of malignancies; Infectious diseases in the last 3 months; Patients with any surgical procedures in the preceding 3 months; Subjects who had a history of angioplasty or coronary by-pass graft surgery; major trauma or an immunologic disease; Subjects who were using steroids, penicillin, oral contraceptive or hormone replacement therapy; Inflammatory bowel disease, psoriasis, multiple sclerosis, systemic lupus erythematosus, myasthenia gravis, autoimmune thyroiditis.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization through random number table: included patients were randomized to receive curcmin or matched-placebo for a period of 3 months. The groups were also matched regarding age. , individual, computer soft-wares
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, principle investigator particularly, healthcare providers (Physicians, nurses, physiotherapists, etc.) . who care for participants during the trial, data collectors, outcome assessors. For the control group, placebo was prescribed in the shape and color and size of the drug.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic's committee of Mashhad University of Medical Sciences
Street address
Quraish bilding of MUMS, daneshghah St, Mashhad, Iran Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2016-11-17, 1395/08/27
Ethics committee reference number
IR.MUMS.fm.REC.1395.374

Health conditions studied

1

Description of health condition studied
CAD
ICD-10 code
I25
ICD-10 code description
Chronic ischaemic heart disease

Primary outcomes

1

Description
Serum level of lipoprotein (a)
Timepoint
at the baseline and 3 months after intervention
Method of measurement
ELISA

2

Description
Serum level of hs-CRP
Timepoint
at the baseline and 3 months after intervention
Method of measurement
ELISA

Secondary outcomes

1

Description
HbA1C
Timepoint
Before intervention and 3 months after intervention
Method of measurement
autoanalyzer bt3000

2

Description
fast blood sugar (FBS)
Timepoint
Before intervention and 3 months after intervention
Method of measurement
autoanalyzer bt3000

Intervention groups

1

Description
The intervention group received routine treatment of heart disease and DMII in accordance with, the administration of curcumin. 1 Soft gel ((SinaCurcumin® (as nano-micelle 80 mg per day)) will be gave to patients for three months. Also, people underwent routine treatments of B-blockers, Aspirins, diuretic drugs, Athro-statins, vasodilators such as NO for heart diseases and metformin and glibangelamide for diabetes.
Category
Treatment - Drugs

2

Description
Control group: In this group, the placebo contains inert oil, with the same color as the drug that the drug manufacturer has produced, was given to patients with heart disease and diabetes for a period of three months, in terms of shape and size, similar to the medicine.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Dr Mostafa Dastani
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Email
rahimihr891@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences,vice chancellor for research
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Quraish bilding of MUMS, daneshghah St, Mashhad, Iran Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3800 2301
Email
rahimihr891@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,vice chancellor for research
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
Hamid Reza Rahimi
Position
MD, Ph.D, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Faculty of Medicine, Azadi Square, Pardis Campus, Mashhad-Iran, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3800 2301
Fax
Email
rahimihr@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mostafa Dastani
Position
MD, Cardiologist, Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Ghaem Hospital in Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3800 2301
Fax
Email
dastanim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Hamid Reza Rahimi
Position
MD, PhD, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Ghaeem hospital in Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 1800 2301
Fax
Email
rahimihr891@mums.ac.ir
Web page address

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
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