| CTRI Number |
CTRI/2024/12/078035 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find relation between causative factors that is Hetu and symptoms of imbalance of Rasavaha Srotas in Ischemic Heart Disease patients |
|
Scientific Title of Study
|
An observational study to find relation between Hetu and Lakshnas of Rasavaha srotas dushti in patients of ischemic heart disease. |
| 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 Shubham Govindrao Thokane |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
Pathology lab room no 115 sector 27 Pradhikaran Nigdi Pune Pune
MAHARASHTRA Pathology lab room no 115 sector 27 Pradhikaran
Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9922602344 |
| Fax |
|
| Email |
shubhamthokane5471@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
Pathology lab room no 115 sector 27 Pradhikaran Nigdi Pune Pune
MAHARASHTRA Pathology lab room no 115 sector 27 Pradhikaran
Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Govindrao Thokane |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre Nigdi Pune |
| Address |
Pathology lab room no 115 sector 27 Pradhikaran Nigdi Pune Pune
MAHARASHTRA Pathology lab room no 115 sector 27 Pradhikaran
Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9922602344 |
| Fax |
|
| Email |
shubhamthokane5471@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune Maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Govindrao Thokane |
| Address |
PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 |
| Type of Sponsor |
Other [PG Scholar ] |
|
|
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 Shubham Govindrao Thokane |
PDEAs Ayurved Rugnalay and Sterling multispeciality Hospital, Nigdi pradhikaran Pune |
Pathology lab room no 115 sector 27 Pradhikaran Nigdi Pune Pune
MAHARASHTRA Pathology lab room no 115 sector 27 Pradhikaran
Nigdi, Pune
Pune
MAHARASHTRA |
9922602344
shubhamthokane5471@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of College of Ayurved and Research Centre Nigdi Pune 411044 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I20-I25||Ischemic heart diseases. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Known case of ischemic heart disease patients will be included
2) Patients between 30 - 60 yrs. of age will be selected.
3) Patients will be selected irrespective of their gender, Religion, Occupation and Socio-economic status. |
|
| ExclusionCriteria |
| Details |
1) Patient having chronic illness such as Rheumatic fever.
2) Patients with organ failure will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the relation between Hetu & Lakshnas of Rasavaha strotas dushti in patients of ischemic heart disease. |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/01/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an Observational study to find relation between Hetu and Lakshnas of Rasavaha srotas dushti in Ischemic Heart Disease patients of age group of 30 to 60 years. Study will help to find causative factors and symptoms in Ischemic Heart Disease patients. Also may help to improve lifestyle for the prevention of heart disease and to maintain healthy condition of heart and circulatory system. |