Effect of Ginger (Zinger offiicinale Roscoe) on clinical symptoms in patients with slow coronary flow on angiography
Design
Phase 2 randomized double-blinded placebo parallel clinical trial on 48 patients Randomization using Randomaization.com
Settings and conduct
This study will perform in the heart ward and clinic of Ghaem Hospital in Mashhad. Patients are randomly assigned to Ginger and placebo groups. Patients and the main researcher are unaware of the group assignment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to admission to the study; Age more than 30 years old; Patients with slow coronary flow with a corrected TIMI frame count of more than 27 frames per second
Exclusion criteria: Cardiovascular disease other than mild coronary atherosclerosis; congenital heart disease; stomach ulcers or duodenal ulcers; Taking anticoagulants such as warfarin, aspirin, and enoxaparin; Breastfeeding or pregnancy; consumption of omega-3 (fish oil), ciprofloxacin, loratadine, escitalopram, montelukast, and levothyroxine; kidney stone
Intervention groups
Intervention group: Patients with slow coronary disease receiving common treatments (including aspirin, statins, beta-blockers and ACEIs) + Ginger 250 mg once daily for one month
Placebo group: Patients with slow coronary disease receiving common treatments + placebo tablet once daily for one month
Main outcome variables
Changes in the score of quality of life according to the EuroQol-VAS (0-100; 100 is the best quality of life and 0 is the worst quality of life)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230625058582N1
Registration date:2023-07-29, 1402/05/07
Registration timing:registered_while_recruiting
Last update:2023-07-29, 1402/05/07
Update count:0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Sara Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2000
Email address
afshars@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ginger (Zinger offiicinale Roscoe) on clinical symptoms in patients with slow coronary flow on angiography
Public title
Effect of Ginger (Zinger offiicinale Roscoe) on patients with slow coronary flow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to admission to the study
Age more than 30 years old
Patients who have less than 50% stenosis in each of the 3 main coronary arteries in their coronary angiography and have delayed filling in at least one of the coronary arteries and have slow coronary flow in a corrected TIMI frame count of more than 27 frames per second
Exclusion criteria:
Stomach ulcers or duodenal ulcers
Taking anticoagulants such as warfarin, aspirin and enoxaparin
Breastfeeding or pregnancy
Consumption of omega 3 (fish oil), ciprofloxacin, loratadine, citalopram, montelukast, and levothyroxine
Kidney stone
History of known congenital heart disease
History of any cardiovascular diseases other than mild coronary atherosclerosis
Age
From 30 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 12 blocks according to the sample size of 48. Then random numbers between 1 and 12 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done using sealed envelopes. Furthermore, due to using a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad
Changes in the score of quality of life according to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life)
Timepoint
Before intervention and one month after beginning the intervention
Method of measurement
According to the EuroQol-VAS scale (0-100; 100 is the best quality of life and 0 is the worst quality of life)
Secondary outcomes
1
Description
Frequent pain during the day
Timepoint
Before intervention and one months after beginning the intervention
Method of measurement
Checklist
2
Description
Duration of pain in minutes
Timepoint
Before intervention and one months after beginning the intervention
Method of measurement
Checklist
3
Description
Quality of life according to Seattle Angina Questionare
Timepoint
Before intervention and one months after beginning the intervention
Method of measurement
Seattle Angina Questionare
Intervention groups
1
Description
Intervention group: Patients with slow coronary artery disease receiving routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with edible ginger rhizome powder at a dose of 250 mg once daily for one month
Category
Treatment - Drugs
2
Description
Control group: Patients with slow coronary artery disease receiving routine treatment (including aspirin, statins, beta-blockers and angiotensin-converting enzyme inhibitors) along with placebo capsule with similar shape, size, and color once daily for one month. The placebo capsule contains 250 mg of Avicel® and is prepared by Dr. Askari's research laboratory at Mashhad University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital in Mashhad
Full name of responsible person
Dr. Sara Afshar
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3801 2739
Email
afshars@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour-Mobarhan
Street address
Qurashi Building, Next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Ramresearch@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
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
Dr. Sara Afshar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza hospital, Ebnsina Blvd
City
MASHHAD
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Fax
Email
afshars@mum.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Sara Afshar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza hospital, Ebnsina Blvd
City
MASHHAD
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Fax
Email
afshars@mum.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Sara Afshar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza hospital, Ebnsina Blvd
City
MASHHAD
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Fax
Email
afshars@mum.ac.ir
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