| CTRI Number |
CTRI/2025/02/081117 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Observational Study to Assess Ayurvedic Pathogenesis of Hypertension |
|
Scientific Title of Study
|
An Observational Study to Assess Ayurvedic Pathogenesis (Samprapti) 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 |
Dr Suyog Jawake |
| Designation |
PG Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita evam Siddhant, Dr. D. Y. Patil College of Ayurveda & Research Centre, Sant Tukaram Nagar,Pimpri Colony, Pimpri -Chinchwad, Pune Maharashtra India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7387099953 |
| Fax |
|
| Email |
jawake.suyog54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrudula Joshi |
| Designation |
Professor Head of Department |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda & Research Centre Pimpri Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, Dr.D.Y.Patil College of Ayurveda & Research Centre, Sant Tukaram Nagar,Pimpri Colony, Pimpri -Chinchwad, Pune Maharashtra India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9226279270 |
| Fax |
|
| Email |
mrudula.joshi@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suyog Jawake |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda & Research Centre, Pimpri, Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, Dr.D.Y.Patil College of Ayurveda & Research Centre, Sant Tukaram Nagar,Pimpri Colony, Pimpri -Chinchwad, Pune Maharashtra India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7387099953 |
| Fax |
|
| Email |
jawake.suyog54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda & Research Centre, Pimpri,Pune-411018 |
|
|
Primary Sponsor
|
| Name |
Dr Suyog Jawake |
| Address |
Dr.D.Y.Patil College of Ayurveda & Research Centre Sant Tukaram Nagar Pimpri Colony Pimpri -Chinchwad Pune Maharashtra India 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Suyog Jawake |
Dr. D.Y. Patil College of Ayurved and Research Centre, Pimpri, Pune. |
Kayachikitsa Department OPD (no.05) and IPD (male and
female), Panchakarma Department OPD (no. 09) and IPD (male and female), Sant Tukaram nagar, Pimpri, Pune, Maharashtra- 411018
Pune
MAHARASHTRA |
7387099953
jawake.suyog54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.DYPCA and RC 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: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Pre diagnosed patient of hypertension
Hypertensive patients of all three grades
|
|
| ExclusionCriteria |
| Details |
Patient having hypertension but not willing to participate in study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is the assessment of the Ayurvedic pathogenesis (Samprapti) of hypertension based on Ayurvedic parameters, including Dosha, Dushya and Srotas involvement in 201 individuals diagnosed with hypertension. |
As this is a cross-sectional study, the outcome will be assessed at a single time point (i.e., at the time of participant recruitment and data collection). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of this study is to assess & analyze the potential etiological factors (Nidana) contributing to hypertension in 201 individuals, based on Ayurvedic principles. |
As this is a cross-sectional study, the secondary outcome will be assessed at a single time point (i.e., at the time of participant recruitment & data collection). |
|
|
Target Sample Size
|
Total Sample Size="201"
Sample Size from India="201"
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)
|
14/03/2025 |
| 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
|
Observational study will be perform on group of randomly selected 201 pre diagsoned hypertensive patients of all three grades and having symptoms like headache dizziness fatigue palpitation insomnia . Detail case taking will be done with case record form. In final outcome with the help of all obseravtions obtain ayurvedic pathogenesis i.e samprapti of hypertenstion will be assessed . |