| CTRI Number |
CTRI/2024/11/076947 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Nitroglycerin Aloe Vera Gel for Angina |
|
Scientific Title of Study
|
Formulation and Evaluation of Nitroglycerin Aloe Vera Gel for Angina |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Imran Ahmad Khan |
| Designation |
Assistant Professor |
| Affiliation |
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan. |
| Address |
Multan
66000
Other |
| Phone |
03336120602 |
| Fax |
|
| Email |
imranahmadkhandurrani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Imran Ahmad Khan |
| Designation |
Assistant Professor |
| Affiliation |
Department of Pharmacy, MNS University of Agriculture, Multan, Pakistan |
| Address |
Multan
Multan
66000
Other |
| Phone |
03336120602 |
| Fax |
|
| Email |
imranahmadkhandurrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Imran Ahmad Khan |
| Designation |
Assistant Professor |
| Affiliation |
Department of Pharmacy, MNS University of Agriculture, Multan, Pakistan |
| Address |
Multan
Multan
66000
Other |
| Phone |
03336120602 |
| Fax |
|
| Email |
imranahmadkhandurrani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Student Research fund of Muhammad Institute of Medical and Allied Sciences, Multan,66000, Pakistan. |
|
|
Primary Sponsor
|
| Name |
QuratUlAin |
| Address |
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan. |
| Type of Sponsor |
Other [Student fund] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Pakistan |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr InamUrRehman |
CPEIC Multan, a tertiary care hospital specializing in cardiac care. |
Emergency department, ground floor, Building A
|
03126827130
dr.inam977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comitte Muhammad Institute of Medical and Allied Sciences Multan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nitroglycerin 6% Aloe Vera Gel |
Route: Topically
to the skin (e.g., chest or upper arms)
Dose: measured dose of the nitroglycerin 6% aloe vera gel Frequency: once daily or during angina onset. |
| Comparator Agent |
SUBLINGUAL Nitroglycerine tab |
Route: SUBLINGUAL Nitroglycerine tab will be given
Frequency: 3 times a day
Dose: 0.5 mg/tab
Total duration: Depending on angina attacks recurrency |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patient at least 25-60-year-old.
• Patient with suspected s angina pectoris who undergo coronary angiography
• Breast feeding mothers
• Intestinal angina
• Hypertensive patient
• Abdominal infarction
• Pregnant female
|
|
| ExclusionCriteria |
| Details |
• severe myocardial infarction
• Cardiogenic shock
• Severe heart faliure
• Hypersensitive to medicine
• Severe hypotension
• Cardiac temponade
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of the 6% nitroglycerin aloe vera gel in relieving angina symptoms through topical administration.
To assess the safety and tolerability of the gel.
To compare the onset and duration of action of the gel with other forms of nitroglycerin (e.g., sublingual tablets).
To evaluate patient compliance and usability of the gel.
To measure improvements in quality of life in patients with chronic angina. |
baseline and after 4 hrs.
when angina settled |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Breathing pattern |
Baseline & after 4 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We purchased Nitromint 2.6 mg tablet of Egis Pharmaceutical ltd. Hungary. I took Fresh aloevera leaves from plant and extracted the latex of aloevera 100 grams. I grinded 6.5 mg Nitro mint bypestle motor and added into 100 grams of aloevera gel mixed it with Robinson mixture for 15minutes per revolution under supervision of quality control test. This 6% nitroglycerin aloe vera gel is designed for topical application to patients with angina at CPEIC Multan. The gel will be applied to areas such as the chest or upper arms where it allows nitroglycerin to be absorbed through the skin producing vasodilation and increasing blood flow to the heart thereby relieving angina symptoms. Aloe vera contributes to skin soothing and healing reducing irritation at the application site. ECG monitors Pulse oximeter (lifecare:fingertip pulseoximeterchina) a thermometer (Hamilton company USA) a stethoscope and mercury manometer were used to record parameters like BP pulse rate blood pressure. Data will be composed after taking written informed consent 80 subjects meeting the eligibility criteria will be incorporated |