| CTRI Number |
CTRI/2018/09/015633 [Registered on: 06/09/2018] Trial Registered Prospectively |
| Last Modified On: |
27/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Coronary Artery Disease Reversal Treatment for patients suffering from Coronary Artery Disease. |
|
Scientific Title of Study
|
A Randomized, Open label, Comparative clinical trial to determine the Efficacy and Safety of Ischemia Reversal Program (IRP) along with diet modification as an add-on therapy to conventional treatment versus conventional treatment alone on plaque volume of Coronary Artery Disease (CAD) patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-IRP-01 Version 1.0 dated 21 Jun 2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Madhav Sane |
| Designation |
Sponsors Principal Investigator |
| Affiliation |
Vaidya Sane Ayurvedic Lab Pvt. Ltd. |
| Address |
701, Ishan Building, 7th Floor, Gokhale Road,
Naupada, Opposite Gaondevi Mandir, Thane (W)
Thane
MAHARASHTRA
400602
India |
| Phone |
91-9867681215 |
| Fax |
|
| Email |
rohitmsane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Mandole |
| Designation |
Research Associate |
| Affiliation |
Vaidya Sane Ayurvedic Lab Pvt. Ltd. |
| Address |
701, Ishan Building, 7th Floor, Gokhale Road,
Naupada, Opposite Gaondevi Mandir, Thane (W)
Thane
MAHARASHTRA
400602
India |
| Phone |
91-9561043299 |
| Fax |
|
| Email |
drrahul@madhavbaug.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Private Limited |
| Address |
Highland Corporate Center,
SB 02,03, 04, 2nd Floor
Near Kapurbawadi Junction, Thane (W)
Thane
MAHARASHTRA
400607
India |
| Phone |
91-9029025200 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Sane Ayurvedic Lab Pvt. Ltd. 701, Ishan Building, 7th Floor, Gokhale Road, Naupada, Opposite Gaondevi Mandir, Thane (W) – 400602,
Maharashtra, India
|
|
|
Primary Sponsor
|
| Name |
Vaidya Sane Ayurvedic Lab Pvt Ltd |
| Address |
701, Ishan Building, 7th Floor, Gokhale Road, Naupada, Opposite Gaondevi Mandir, Thane (W)- 400602, Maharashtra, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jagdish Hiremath |
Grant Medical Foundation Ruby Hall Clinic |
Dept. of Cardiology, Room no 40,Ground Floor, Sassoon Road, Pune
Pune
MAHARASHTRA |
91-9822022441
drjagdishhiremath@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ischemia Reversal Program (IRP) and Reverse Diet Kit as an add on regimen to standard cardiac therapy |
Ischemia Reversal Program (IRP) is a three-pronged Ayurvedic Panchakarma therapy which includes a) Snehana (External Oleation) b) Swedana (Passive Heat Therapy) & c) Basti (Medicated enema) regimen. The investigation product used are as follows. (a) Snehana - Administration of centripetal massage using Sesame oil with essence of Lavender oil (b)Swedana- Administration of passive heat to the body using Dashmool decoction (c) Basti- Per rectal administration of a fixed quantity of Gokshura (Tribulus terrestris), Haridra (Curcurma longa) and Amalaki (Emblica officinalis) decoction.
Reverse Diet Kit- It is a specially designed low calories, low carbohydrates, moderate protein and fat with high anti oxidation capacity diet having rich source of vitamin C, vitamin E, potassium, omega 3 fatty acid and low sodium content.
|
| Comparator Agent |
Standard Cardiac Therapy |
Stable dose of standard cardiac therapy like Anti-platelet agents and statin group as per PI discretion |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects between 40 to 75 years of age.
2. Subjects with known case of significant Coronary Artery Disease (CAD) with soft plaque as detected by Intravascular Ultrasound (IVUS) guided angiography.
3. Subjects with known case of CAD with stable dose of standard therapy for at least 3 months.
4.Subjects with BMI in the range of 26 to 30 kg/m2.
5.Subjects with known case of Type 2 Diabetes Mellitus with HbA1c value between 7% to 8% (on regular and stable medication from last 3 months).
6.Subjects with known case of controlled Hypertension with blood pressure up to 130/90 (on regular and stable medication since last 3 months).
7. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
|
|
| ExclusionCriteria |
| Details |
1. Subject with severe Calcified plaque or no plaque as detected by Intravascular Ultrasound (IVUS) guided angiography.
2. Subjects with history of Coronary artery bypass grafting (CABG).
3. Subjects with known case of symptomatic CAD (Chest pain at Rest).
4. Subjects with recent acute coronary syndrome (within last 3 months).
5. Subjects with acute heart failure (within 24 hrs).
6. Subjects with Irritable bowel syndrome.
7. Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles).
8. Subjects with Hemorrhoids (2nd or 3rd degree).
9. Subject with known case of Asthma or COPD.
10. Subjects with known case of Cancer.
11. Subjects with physical disability in any form leading to immobilization.
12. Subjects with Anemia (Hemoglobin less than 10 gm/dL).
13. Subjects with known case of Thyroid dysfunction.
14. Subjects with hepatic or renal insufficiency.
15. Subjects with suspected inability or unwillingness to comply with the study procedures.
16. Subjects with suspected hypersensitivity to any of the ingredients of study medication.
17. Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
18. Suspected inability or unwillingness to comply with the study procedures.
19. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Mean Plaque volume using IVUS guided angiography |
Reduction in mean Plaque volume from baseline to end of study visit (120 days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in maximum atheroma area in IVUS guided angiography |
Reduction in atheroma area in IVUS guided angiography from baseline to the end of study visit (120 days) |
| Mean change in external elastic membrane (EEM) |
Reduction in external elastic membrane from baseline to end of study visit (120 days) |
| Mean change in Apo A1 |
Improvement in Apo A1 from baseline to end of study visit (120 days) |
| Mean change in Apo B |
Reduction of Apo B from baseline to end of study visit (120 days) |
| Mean change in Summed difference score in Myocardial perfusion imaging |
Reduction in summed difference score in Myocardial perfusion imaging from baseline to end of study visit (120 days) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, open label comparative clinical
trial to determine the Efficacy and Safety of Ischemia Reversal Program (IRP)
along with diet modification as an add-on therapy to conventional treatment
versus conventional treatment alone on plaque volume of Coronary Artery Disease
(CAD) patients.
The
primary endpoint of the study is to determine the reduction in mean plaque
volume of CAD patients at the end of 120 days using Intravascular Ultrasound
(IVUS) guided angiography.
The
secondary endpoints of the study are as follows: 1. Determination of reduction
in maximum atheroma area 2. Determination of reduction in EEM (External Elastic
Membrane) area 3. Evaluation of improvement in Apo A1 4. Evaluation of
reduction in Apo B 5. Determination of reduction in summed difference score in Myocardial
Perfusion Imaging (MPI)/SPECT tests
Also, safety will be assessed based on
frequency, severity and intensity of adverse events (AEs) and changes in the
laboratory values.
|