This study plan outlines the detailed methodology for conducting a clinical trial to evaluate the efficacy, safety, and usability of a nitroglycerin 6% aloe vera gel for the treatment of angina.
Design
Pragmatic, community based, parallel group, double blinded, randomized controlled trial. Total 144 patients will be enrolled. Patients who met our inclusion criteria will be randomized into two groups.
Settings and conduct
• CPEIC Multan, a tertiary care hospital specializing in cardiac care.
• Muhammad Rehabilitation Centre, Multan
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patient at least 25-60-year-old.
• Patient with suspected s angina pectoris who undergo coronary angiography
• Chest pain
• Symptoms of chest pain
• Breast feeding mothers
• Intestinal angina
• Hypertensive patient
• Abdominal infarction
• Pregnant female
Exclusion criteria:
• severe myocardial infarction
• Cardiogenic shock
• Severe heart faliure
• Hypersensitive to medicine
• Severe hypotension
• Cardiac temponade
Intervention groups
Participants will be assigned to two groups. Group 1 will be given 6% nitroglycerin aloe vera gel and group 2 will be given sublingual nitroglycerine
Main outcome variables
Primary Outcome: Reduction in pain, reduction in the frequency and severity of angina episodes, as measured by patient diaries and angina-specific questionnaires (e.g., the Seattle Angina Questionnaire ) AND ECG: ST-Segment Changes Reduction in ischemic changes on ECG.
Secondary outcome: Changes in breathing pattern, reduction in shortness of breath
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230202057310N9
Registration date:2024-11-21, 1403/09/01
Registration timing:prospective
Last update:2024-11-21, 1403/09/01
Update count:0
Registration date
2024-11-21, 1403/09/01
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-01, 1403/09/11
Expected recruitment end date
2024-12-30, 1403/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Formulation and Evaluation of Nitroglycerin 6% Aloe Vera Gel for Angina
Public title
Nitroglycerin 6% Aloe Vera Gel for Angina
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient at least 25-60-year-old of both genders
Patient with suspected angina pectoris who undergo coronary angiography
Intestinal angina
Hypertensive patient
Chest pain
Pregnant female
Breast feeding mothers
Symptoms of chest pain
Exclusion criteria:
Severe myocardial infarction
Cardiogenic shock
Severe heart failure
Severe hypotension
Hypersensitive to medicine
Cardiac temponade
Age
From 25 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Multan
City
MULTAN
Postal code
66000
Approval date
2024-09-11, 1403/06/21
Ethics committee reference number
MIMAS/08/26/Imran
Health conditions studied
1
Description of health condition studied
Angina pain
ICD-10 code
I20
ICD-10 code description
Angina pectoris
Primary outcomes
1
Description
Reduction in pain
Timepoint
Before and after treatment
Method of measurement
Numerical pain rating scale (NPRS)
2
Description
reduction in the frequency and severity of angina episodes
Timepoint
Before and after treatment
Method of measurement
Angina-specific questionnaires (e.g., the Seattle Angina Questionnaire )
3
Description
Reduction in ischemic changes on ECG
Timepoint
Before and after treatment
Method of measurement
ECG: ST-Segment Changes
Secondary outcomes
1
Description
Changes in breathing pattern
Timepoint
before and after treatment
Method of measurement
Breathing pattern
Intervention groups
1
Description
Intervention group: Group 1 will be given 6% nitroglycerin aloe vera gel. We will apply a measured dose of the nitroglycerin 6% aloe vera gel to the skin (e.g., chest or upper arms) once daily or during angina onset.
Category
Treatment - Drugs
2
Description
Control group: group 2 will be given sublingual nitroglycerine. Nitroglycerine (0.5mg) tab will be given sublingually
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
CPEIC Multan, a tertiary care hospital specializing in cardiac care.
Full name of responsible person
Dr. Inam Ur Rehman
Street address
Abdali Road
City
Multan
Postal code
66000
Phone
+92 333 6120602
Email
dr.inam977@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Muhammad Rehabilitation Centre, Multan
Full name of responsible person
Kashaf Khan Anjum Bhutta
Street address
Bosan Road Multan
City
Multan
Postal code
66000
Phone
+92 326 0107374
Email
kashafbhutta1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Dr. Zahid Manzor
Street address
Multan
City
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
kashafbhutta1@gmail.com
Grant name
Student Fund
Grant code / Reference number
MIMAS/10/06/IAK
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Proportion provided by this source
70
Public or private sector
Private
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
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Kashaf Khan Anjum Bhutta
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
kashafbhutta1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture
Full name of responsible person
Imran Ahmad Khan
Position
Coordinator Department of Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Kashaf Khan Anjum Bhutta
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
kashafbhutta1@gmail.com
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
N/A
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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