| CTRI Number |
CTRI/2025/07/089964 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying Heart Changes in People with Kaphaj Hrudroga Using 2D Echocardiography. |
|
Scientific Title of Study
|
A cross sectional study of structural involvement and changes in heart in patients of kaphaj hrudroga using 2D echocardiography. |
| 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 Pravin Keshao Girhe |
| Designation |
Pg scholar |
| Affiliation |
PDEAS College of Ayurveda and research centre Pune |
| Address |
PDEAS College of Ayurveda and research centre Sharir Rachana Department Ground floor Nigdi Pune Maharashtra PDEAS College of Ayurveda and research centre sharir Rachana Department ground floor Nigdi Pune Maharashtra 411044 Pune MAHARASHTRA 411044 India |
| Phone |
8378917280 |
| Fax |
|
| Email |
pravingirhe5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madhuri Mahadar |
| Designation |
Associate Professor |
| Affiliation |
PDEAS College of Ayurveda and research centre |
| Address |
PDEAS College of Ayurveda and research centre sharir Rachana department ground floor Nigdi Pune Maharashtra
Pune MAHARASHTRA 411044 India |
| Phone |
9822002667 |
| Fax |
|
| Email |
drmadhuri75@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madhuri Mahadar |
| Designation |
Associate Professor |
| Affiliation |
PDEAS College of Ayurveda and research centre |
| Address |
PDEAS College of Ayurveda and research centre sharir Rachana department ground floor Nigdi Pune Maharashtra
Pune MAHARASHTRA 411044 India |
| Phone |
9822002667 |
| Fax |
|
| Email |
drmadhuri75@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and research centre Rachana sharir department ground floor nigdi Pune Maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and research centre |
| Address |
PDEAS College of Ayurved and research centre Rachana sharir department ground floor nigdi Pune Maharashtra 411044 |
| 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 |
| Pravin Keshao Girhe |
Ayurved Rugnalaya and sterling and multispeciality hospital |
Ayurved Rugnalaya and sterling and multispeciality hospital nigdi pradhikaran pune Pune MAHARASHTRA |
8378917280
pravingirhe5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Ethics Committee College of Ayurved And Research Centre Akurdi Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I509||Heart failure, unspecified. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Prior diagnosed patients of kaphaj hrudroga who have recent reports of 2D Echocardiography |
|
| ExclusionCriteria |
| Details |
1. Patient who is suffering from Congenital heart disease.
2) Patient who have undergone coronary artery bypass graft.
3) Patient who have undergone percutaneous transluminal coronary angioplasty, valvular replacement.
4) Known cases of HIV, TB. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out structural involvements and changes in Heart in patients of Kaphaj Hrudroga using 2D Echocardiography. |
1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
16/07/2025 |
| 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 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
|
Kaphaj Hrudroga is a type of heart disease described in Ayurveda, caused primarily by the aggravation of Kapha dosha. It manifests with a distinct set of symptoms that reflect the heavy, sticky, and cold qualities of Kapha. Patients often report a feeling of stiffness and heaviness in the region of the heart, which is a hallmark of Kapha dominance. There is also a peculiar sensation as if the heart is wrapped in a wet cloth, indicating the damp and constrictive influence of aggravated Kapha on the heart’s function.
Other characteristic symptoms include excessive salivation, which is a sign of increased Kapha in the oral cavity and digestive tract. Mild fever, persistent cough, and drowsiness or lethargy are commonly present, reflecting systemic Kapha imbalance. These symptoms suggest impaired circulation, reduced metabolic fire (Agni), and congestion in the cardiac and respiratory pathways.
From an Ayurvedic perspective, Kaphaj Hrudroga is not merely a structural issue but a functional disorder of the doshas affecting the Rasavaha and Pranavaha Srotas. Early identification and appropriate treatment aimed at pacifying Kapha—through diet, lifestyle, and herbal remedies—are essential to prevent progression and maintain cardiac health. |