The effects of Ginger (Zinger offiicinale) on the prevention of PVC in patients with palpitation
Design
Phase 2-3 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 Imam Reza 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; Patients with heart palpitations; The number of PVCs during one day less than 15% in the 24-hour Holter rhythm.
Not inclusion criteria: Previous history of heart palpitations; History of receiving medications for PVC ; Structural heart disorder; stomach ulcers or duodenal ulcers; Taking anticoagulants such as warfarin, aspirin, and enoxaparin; Breastfeeding or pregnancy; consumption of omega-3, ciprofloxacin, loratadine, escitalopram, montelukast, and levothyroxine; kidney stone; History of taking medicines containing ginger.
Intervention groups
Patients with heart palpitations receiving Ginger capsule (250 mg once daily) for ten days
Main outcome variables
Number of PVCs during 24 h
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054874N13
Registration date:2023-10-11, 1402/07/19
Registration timing:registered_while_recruiting
Last update:2023-10-11, 1402/07/19
Update count:0
Registration date
2023-10-11, 1402/07/19
Registrant information
Name
Vafa Baradaran Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2301
Email address
baradaranrv@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2025-10-07, 1404/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Ginger (Zinger offiicinale Roscoe) on the prevention of PVC in patients with palpitation
Public title
The effects of Ginger (Zinger offiicinale Roscoe) on the prevention of PVC in patients with palpitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with heart palpitations
The number of PVCs during one day less than 15% in the 24-hour Holter rhythm
Consent to admission to the study;
Exclusion criteria:
Previous history of heart palpitations
History of receiving medications for PVC
Structural heart disorder
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 taking medicines containing ginger
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
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
Before intervention and 10 days after beginning the intervention
Method of measurement
24-hour Holter rhythm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with heart palpitations receiving capsule containing ginger rhizome powder at a dose of 250 mg once daily for 10 days.
Category
Treatment - Drugs
2
Description
Control group: Patients with heart palpitations receiving placebo capsule with similar shape, size, and color once daily for 10 days. 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
Department of Cardiology, Imam Reza Hospital
Full name of responsible person
Dr. Sara Afshar
Street address
Imam Reza hospital, Ebnsina Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
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. Mosen Tafaghodi
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. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Vafa Baradaran Rahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ghaeem hospital, Ahmadabad Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
0095 5138012739
Email
baradaranrv@mums.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