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The effect of Curcuma Longa on the chest pain, sleep quality and hemodynamic indices in patients with acute coronary syndrome

Protocol summary

Study aim
To determine the effect of Curcuma Longa on the chest pain, sleep quality and hemodynamic indices in patients with acute coronary syndrome
Design
Clinical Trial, by using block randomization, the Patients enter in intervention, placebo or control group, A pilot study including10 patients from each group, will determine the size of the sample, Parallel groups, double blind.
Settings and conduct
This study is performed in the intensive cardiac care unit of Kosar Hospital in Semnan. The medicine is given to the patient by the physician (double blind), the researcher and patient did not know about the Curcuma Longa and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis acute coronary syndrome, patient consent for participation in the study, patient 45 to 75 years old, lack of active mental illness, mental retardation, deafness, blindness, lack of sensitivity to Curcuma Longa, lack of addiction to alcohol and Opioid, patients who are able to speak and understand language and conscious, no history of sleeping drugs consumption, chest pain score greater than four, systolic blood pressure 90-100 mmHg. Exclusion criteria: pregnant women, patients with gallstones or bile disorders.
Intervention groups
The intervention group received one 500 mg Curcuma Longa tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen. The control group 1 group receives placebo tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen. The control group 2 receives routine regimen.
Main outcome variables
Evaluation of pain is performed with Numeric Rating Scale; sleep quality by St Mary's Hospital Sleep Questionnaires; evaluation of hemodynamic indicators by the monitor of Pooyandegan Rah-e-Salamat

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110427006318N14
Registration date: 2020-10-22, 1399/08/01
Registration timing: prospective

Last update: 2020-10-22, 1399/08/01
Update count: 0
Registration date
2020-10-22, 1399/08/01
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-24, 1399/08/03
Expected recruitment end date
2021-04-23, 1400/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Curcuma Longa on the chest pain, sleep quality and hemodynamic indices in patients with acute coronary syndrome
Public title
The effect of Curcuma Longa on the chest pain, sleep quality and hemodynamic indices in patients with acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis acute coronary syndrome Patient consent for participation in the study Patient 45 to 75 years old Lack of active mental illness, mental retardation, deafness, blindness Lack of sensitivity to Curcuma Longa Lack of addiction to alcohol and Opioid Patients who are able to speak and understand language and conscious No history of sleeping drugs consumption Chest pain score greater than four Systolic blood pressure 90-100 mmHg
Exclusion criteria:
Pregnant women Patients with gallstones or bile disorders
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample assigned to the groups of the study by permuted blocks randomization. The blocks will be (ABC, ACB, BAC, BCA, CAB, CBA), A is the intervention group, B is the control group 1 and C is the control group 2. After randomly selecting one of the six possible blocks, three consecutive samples are randomly placed in one of the groups (intervention, control 1 or control 2). Blocking is used within sex, randomization is done separately for men and women.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medicine is given to the patient by the physician, so that the researcher and the patients participating in the study do not know about the type of intervention (Curcuma Longa, control 1 or control 2) and do not know who is in which group (double blind).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical science
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
351313811
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC.1399.183

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Chest pain
Timepoint
Evaluation of pain is performed before and half an hour after the intervention for three consecutive days.
Method of measurement
Numeric Rating Scale

Secondary outcomes

1

Description
Sleep quality
Timepoint
Evaluation of sleep quality is performed before the intervention and three consecutive days.
Method of measurement
St Mary's Hospital Sleep Questionnaires

2

Description
Hemodynamic indicators
Timepoint
Evaluation of hemodynamic parameters is performed before and half an hour after the intervention for three consecutive days.
Method of measurement
Monitor of Pooyandegan Rah-e-Salamat

Intervention groups

1

Description
Intervention group: The intervention group received one 500 mg Curcuma Longa tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen.
Category
Treatment - Other

2

Description
Control group: The control group 1 receives placebo tablet once a day, 9 am after breakfast, for three days, in addition to routine regimen.
Category
Placebo

3

Description
Control group: The control group 2 receives routine regimen.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Monir Nobahar
Street address
Faculty Nursing and Midwifery, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nobahar43@semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data is confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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