| CTRI Number |
CTRI/2024/03/064557 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY MEDOVAHA SROTAS DUSHTI IN HYPERTENSIVE PATIENTS |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY OF MEDOVAHA SROTAS DUSHTI IN PATIENTS OF HYPERTENSION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAISHALI HARIBHAU SHINDE |
| Designation |
PG Scholar |
| Affiliation |
Tilak ayurved mahavidyalaya |
| Address |
Rognidan department,Tilak ayurved mahavidyalaya, rasta peth , Pune MAHARASHTRA
411011 Tarachand hospital ,Rasta peth ,Pune MAHARASHTRA
411011
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411011
India |
| Phone |
7774990381 |
| Fax |
|
| Email |
vhshinde175@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Naik |
| Designation |
MD Associate Professor(rognidan evum vikriti vigyan) |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Rasta peth, Pune. |
| Address |
Tilak Ayurved Mahavidyalaya Rasta peth Pune Tarachand Hospital
Rasta Peth Pune MAHARASHTRA 411011
Pune
MAHARASHTRA
411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9422003150 |
| Fax |
|
| Email |
vidya.r.naik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Naik |
| Designation |
MD Associate Professor(rognidan evum vikriti vigyan) |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Rasta peth, Pune. |
| Address |
Tilak Ayurved Mahavidyalaya Rasta peth Pune Tarachand Hospital
Rasta peth Pune MAHARASHTRA 411011
Pune
MAHARASHTRA
411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9422003150 |
| Fax |
|
| Email |
vidya.r.naik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya ,Rasta peth,Pune |
| 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 |
| Dr Vaishali Haribhau Shinde |
Tilak Ayurved Mahavidyalaya |
Tilak Ayurved
Mahavidyalaya,Rasta
peth,Pune. Rognidan
Department Seth
Tarachand Hospital.
Lab number 18 Pune
MAHARASHTRA
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7774990381
vhshinde175@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TILAK AYURVED MAHAVIDYALAYA AND SHETH TARACHAND RAMNATH CHARITABLE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: Hypertension, (2) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: Hypertension , (3) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HRUDROGAH, (4) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HRUDROGAH, (5) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals belonging to age group between 20-70 years of age.
2.patient diagnosed with hypertension. 3.Participants will be selected irrespective of religion, marital. |
|
| ExclusionCriteria |
| Details |
patients belonging to age group below 20 years and above 70 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of medovaha srotas dushti in patients of hypertension. |
18 months, 0 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Association of meda dhatu kshaya in patients of hyertension.
2.Association of meda dhatu vriddhi in patients of hyertension. |
18 months, 0 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/04/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Association of medovaha strotas dushti in hypertensive patients To study medodhatu vruddhi in hypertensive patients To study medo dhatu kshay in hypertensive patients |