| CTRI Number |
CTRI/2022/06/043244 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
01/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical Study to see effect and safety of Ayurveda-Based Coronary Plaque Stabilization Program in Known CAD Subjects with Chronic Heart Disorders. |
|
Scientific Title of Study
|
A Multicentre, Single Arm, Open Label, Long-Term Prospective Study to Evaluate the Efficacy and Safety of Ayurveda-Based Coronary Plaque Stabilization Program in Known CAD Subjects with Chronic Heart Disorders. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-PSP-01 version 1.0 dated 15 jun 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagdish Hiremath |
| Designation |
Principal Investigator |
| Affiliation |
Madhavbaug Institute of Preventive Cardiology |
| Address |
Ishan Tower, Building No.2, 701, 7th Floor, Gokhale Road, Naupada, Thane (West) – 400602, Maharashtra, India
Thane
MAHARASHTRA
400602
India |
| Phone |
9822022441 |
| Fax |
|
| Email |
drjagdishhiremath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Mandole |
| Designation |
Senior Research Associate |
| Affiliation |
Vaidya Sane Ayurvedic Lab Pvt. Ltd |
| Address |
Ishan Tower, Building No.2, 701, 7th Floor, Gokhale Road, Naupada, Thane (West) – 400602, Maharashtra, India
Thane
MAHARASHTRA
400602
India |
| Phone |
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, Second Floor, Near Kapurbawdi Junction, Thane West
Thane
MAHARASHTRA
400607
India |
| Phone |
022-41006794 |
| 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. |
|
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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 |
Pharmaceutical industry-Indian |
|
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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 Hiemath |
Vaidya Sane’s Ayurvedic Education and Agricultural Research Trust’s MIPC |
Ishan Tower, Building No.2, 701, 7th Floor, Gokhale Road, Naupada, Thane (West) – 400602, Maharashtra, India
Thane
MAHARASHTRA |
9822022441
drjagdishhiremath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VRT’s MIPC Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I251||Atherosclerotic heart disease of native coronary artery. Ayurveda Condition: HRUDROGA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pradhamanakarma, पà¥à¤°à¤§à¤®à¤¨à¤•à¤°à¥à¤® | (Procedure Reference: Pranayama, Procedure details: (Procedure Reference: , Procedure details: Cohort I, II and III 1.Snehana (Centripetal Oleation) 2.Swedana (Thermal Vasodilation) 3.Basti (Per rectal herb decoction administration) Cohort II will additionally have 1.Hrudaydhara (Local showering of decoctions/medicated oils) Treatment duration for 12 weeks and Reverse diet Kit for 90 days ))
|
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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 CAD with Total atheroma volume more than 150 mm3.
3.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
Cohort I-IHD:
i.Stress test positive for inducible ischaemia.
ii.MET value < 7.
Cohort II-CHF:
i.Stress test negative for inducible ischaemia.
ii.MET value < 7.
Cohort III-For Asymptomatic CAD:
i.Stress test negative for inducible ischaemia.
ii.MET value > 7.
|
|
| ExclusionCriteria |
| Details |
1.Subject with severe Calcified plaque or no plaque as detected by Coronary Computed Tomographic (CCT) 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 24hrs).
6.Subjects with all anomalies of coronary arteries.
7.Subjects with uncontrolled hypertension with blood pressure ≥ 180/100 mm Hg.
8.Subjects with BMI < 23 kg/m2.
9.Subjects with Type 1 Diabetes Mellitus.
10.Subjects with uncontrolled Type 2 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.Known case of CKD Sr Creatinine >1.5mg/dL
16.Subjects with abnormal Liver Function Test (LFT) with values more than 3 times the upper limit of normal.
17.Known HFrEF with LVEF <40%
18.Subjects with physical disability in any form leading to immobilization.
19.Subjects with Irritable Bowel Syndrome (IBS).
20.Subjects with clinically diagnosed bleeding piles or prolapsed fistula (Grade I or II piles).
21.Subjects with Hemorrhoids (2nd or 3rd degree).
22.Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
23.Subjects with suspected inability or unwillingness to comply with the study procedures.
24.Female subjects who are pregnant or lactating or planning to become pregnant during the study period.
25.Females who are not ready to use acceptable contraceptive methods during the course of study
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Mean change in Total Atheroma Volume (TAV) from baseline to end of study visit using Coronary Computed Tomographic (CCT) angiography |
84±2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percent change in Weight from baseline to end of study |
84±2 days |
| Percent change in Abdominal girth from baseline to end of study |
84±2 days |
| Percent change in LDL from baseline to end of study |
84±2 days |
| Percent change in TG from baseline to end of study |
84±2 days |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/06/2022 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a multicentre, single arm, open label, clinical study. Subjects will be assigned to following treatment. Cohort I-IHD: IRP (Panchakarma 21 sittings) + Reverse Diet Kit 2. Cohort II-CHF: HFRT(Panchakarma 21 sittings) + Reverse Diet Kit 3. Cohort III-For Asymptomatic CAD: PSL (Panchakarma 21 sittings) + Reverse Diet Kit There will be twice-a-week sitting of treatment for 10 weeks i.e.20 sittings and once-a-week sitting of treatment at week 11 i.e. (total 21 sittings) and a follow-up visit at week 4/day 30±2 , week 8/day 60±2 and end of study visit at week 12/90±2. Conventional treatment and reverse diet kit will be continued throughout the study till the end of study visit. Primary endpoint - Mean change in Total Atheroma Volume (TAV) from baseline to end of study visit using Coronary Computed Tomographic (CCT) angiography Seconday endpoint - Percent change in Weight from baseline to end of study - Percent change in Abdominal girth from baseline to end of study - Percent change in LDL from baseline to end of study - Percent change in TG from baseline to end of study
|