CTRI Number |
CTRI/2019/08/020555 [Registered on: 05/08/2019] Trial Registered Prospectively |
Last Modified On: |
02/08/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Other |
Public Title of Study
|
Ayurvedic management of hridaya roga |
Scientific Title of Study
|
clinical evaluation of the effect of hridyamrita vati with arjuna ksheer paka as anupana in vataja hridya roga w.s.r. stable angina . |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Dhruv Mishra |
Designation |
Associate Professor |
Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Address |
Patanjali Ayurved college , Haridwar, Uttarakhand Dr Dhruv Mishra
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar
Patanjali Ayurved College hardwar Hardwar UTTARANCHAL 249405 India |
Phone |
8449418880 |
Fax |
|
Email |
dr.dhruvmishra@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Dhruv Mishra |
Designation |
Associate Professor |
Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Address |
Patanjali Ayurved College, Haridwar, Uttarakhand Dr Dhruv Mishra
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar
Patanjali Ayurved College hardwar Hardwar UTTARANCHAL 249405 India |
Phone |
8449418880 |
Fax |
|
Email |
dr.dhruvmishra@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Dhruv Mishra |
Designation |
Associate Professor |
Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Address |
51 C Nakshtra Vatika Homes Swami Bhumanand Hospital Campus Ranipur Jhal Jwalapur Haridwar Uttarakhand Dr Dhruv Mishra
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar
Patanjali Ayurved College hardwar Hardwar UTTARANCHAL 249405 India |
Phone |
8449418880 |
Fax |
|
Email |
dr.dhruvmishra@gmail.com |
|
Source of Monetary or Material Support
|
Divya Pharmacy Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Hardwar |
|
Primary Sponsor
|
Name |
Patanjali Ayurved College |
Address |
Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Type of Sponsor |
Research institution and hospital |
|
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 |
Anupama Rai |
patanjali ayurved college |
Patanjali Ayurveda Hospital , Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Hardwar UTTARANCHAL |
6397986263
rai.41721@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
PAC/Institutional Ethics Committee/2017-18/14 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Hridyamrita Vati with Arjuna Ksheerpaka as Anupana |
Hridyamritavati with Arjun KsheerPaka - Orally
Dose of Medicine:Hridyamritavati- 2 tab Twice a day After meal with 40 ml Arjun ksheerpaka.
for 3 cosecutive months, with in 3 followups.
|
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Pre-diagnosedcase of stable angina.
2. Patients between the age group of 18-65yrs will be selected.
3. Patients irrespective of sex, religion, occupation and chronicity will be selected.
|
|
ExclusionCriteria |
Details |
1. Obstructive CAD>80% luminal diameter stenosis in > 1epicardial coronary artery
2. Patient of acute MI(myocardial infarction), DM, coma,
3. Patient of abnormal heart beat.
4. Chest pain due to non-cardiac problems.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Subjective parameters are:
(Ayurveda)
1. Bheda(Tearing pain)
2. Hridayashunyabhava(Numbness)
3. Stambha(Chest congestion)
4. Drava (Palpitations)
5. Shosha(Mukhshosha /dryness of mouth)
(Modern)
1. 6 MWT (6 minute walk test)/ Physical exertion
2. Angina (5min. or Less)
3. Abdominal gas or indigestion feeling
4. Radiating pain- arm, back or others.
5. Relieved by- rest or medicines.
|
just before intervention of hridyamrita vati with arjun ksheer paka as anupana in vataja hridya roga
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Subjective parameters are:
(Ayurveda)
1. Bheda(Tearing pain)
2. Hridayashunyabhava(Numbness)
3. Stambha(Chest congestion)
4. Drava (Palpitations)
5. Shosha(Mukhshosha /dryness of mouth)
(Modern)
1. 6 MWT (6 minute walk test)/ Physical exertion
2. Angina (5min. or Less)
3. Abdominal gas or indigestion feeling
4. Radiating pain- arm, back or others.
5. Relieved by- rest or medicines.
|
just after intervention of hridyamrita vati with arjun ksheer paka as anupana in vataj hridya roga ( stable angina |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 3 |
Date of First Enrollment (India)
|
06/08/2019 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
In this trial, we are selecting the patients of vataj hridya roga (stable angina), In which we will do the intervention in one group of 40 patients. We will intervene with ayurvedic management of vataj hridya roga with Hridyamrit vati 2 tab. twice a day with Arjun ksheer paka as anupana for 3 months with 3 followups. Assessment should be done on the basis of assessment criteria done on the basis of pre treatment and post treatment. |