| CTRI Number |
CTRI/2020/01/022814 [Registered on: 16/01/2020] Trial Registered Prospectively |
| Last Modified On: |
27/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Ischemia Reversal Program (IRP) along with diet modification for subjects suffering Coronary Artery Disease (CAD). |
|
Scientific Title of Study
|
A Multicentre, Single arm, Open label, 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 on plaque volume of Coronary Artery Disease (CAD) subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-IRP-01 Version 2.0 dated 28 Nov 2019 |
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 |
Senior 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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Badani |
Aditya Birla Memorial Hospital |
Department of Cardiac Sciences, Aditya Birla Memorial Hospital.
Aditya Birla Memorial Hospital marg, Thergaon, Chinchwad,
Pune-411033, Maharashtra, India
Pune
MAHARASHTRA |
91-9823818400
badani_rajesh@yahoo.co.in |
| Dr Manoj Chopada |
Chopda Medicare & Research Centre Pvt. Ltd.; Magnum Heart Institute |
Department of Cardiology ,Chopda Medicare & Research Centre Pvt. Ltd.; Magnum Heart Institute,Plot no. 3/5, Laxmi Nagar, Patil Lane No. 1, Near K. B. H. Vidyalaya, Opp. Vasant Market Canada Corner, Nashik-422005,Maharashtra ,India
Nashik
MAHARASHTRA |
91-9823021613
0253-2313613
rush_manoj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Aditya Birla Memorial Hospital Ethics Committee |
Approved |
| Magna-Care Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| 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 antioxidation capacity diet having
rich source of vitamin C, vitamin E, potassium, omega 3 fatty acid and low sodium content.
Total 24 IRP sittings will be given to subjects after enrollment, in the span of 16 weeks.During first 8 weeks 2 IRP seetings weekly and During next 8 weeks 1 IRP sitting weekly.Reverse diet kits will be given to every subject for the entire duration of study.Stable dose of standard cardiac therapy like Anti-platelet agents and statin group will be continued throughout the study period. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subjects between 40 to 75 years of age.
2.Subjects with diagnosis of significant Coronary Artery Disease (CAD) with Non significant atherosclerotic plaque ≥ 30% to≤70% in target vessel which should be of minimum of 40 mm as detected by Intravascular Ultrasound(IVUS) guided angiography.
3.Subjects with known case of Type 2 Diabetes Mellitus (on regular and stable medication from last 3 months).
4.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 total atheroma volume of ≤ 50mm3 as detected by Intravascular Ultrasound (IVUS) guided angiography at screening visit.
3.Subjects with history of Coronary Artery Bypass Grafting (CABG) and Percutaneous transluminal coronary angioplasty (PTCA).
4.Subjects with known case of symptomatic CAD (Chest pain at Rest).
5.Subjects with recent acute coronary syndrome (within last 3 months).
6.Subjects with acute heart failure (within 24hrs).
7.Subjects with all anomalies of coronary arteries.
8.Subjects with uncontrolled hypertension with blood pressure ≥ 180/100 mm Hg.
9.Subjects with BMI < 23 kg/m2.
10.Subjects with Type 1 Diabetes Mellitus.
11.Subjects with known case of Diabetic ketoacidosis.
12.Subjects with known case of Active malignancy
13.Subjects with known case of Hyperthyroidism.
14.Subjects with serum creatinine level ≥ 2 mg/dL.
15.Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
16.Subjects with physical disability in any form leading to immobilization.
17.Subjects with Irritable bowel syndrome.
18.Subjects with clinically diagnosed bleeding piles or prolapsed or fistula (grade I or II piles).
19.Subjects with Hemorrhoids (2nd or 3rd degree).
20.Subjects with suspected inability or unwillingness to comply with the study procedures.
21.Subjects with known case of Soya food allergy
22.Subjects with suspected hypersensitivity to any of the ingredients of study medication.
23.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
24.Suspected inability or unwillingness to comply with the study procedures.
25.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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Percentage change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography |
120 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Percentage of population achieving change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography.
2.Determination of change in Percentage Atheroma Volume (PAV) from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography. |
120 days. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
20/01/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Multicentre, Single arm, Open label, 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 on plaque volume of Coronary Artery Disease (CAD) subjects.
The Primary Endpoint is 1. Percentage change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography. The Secondary Endpoint is 1.Percentage of population achieving change in Total atheroma volume (TAV) of ≥ 0.3% from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography. 2.Determination of change in Percentage Atheroma Volume (PAV) from baseline to end of study visit using Intravascular Ultrasound (IVUS) guided angiography.
The safety will be assessed based on the frequency of Adverse Events and changes in laboratory values. |