| CTRI Number |
CTRI/2026/02/103035 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify the Ayurveda based causes associated with High Blood Pressure in the Patients of Primary Hypertension. |
|
Scientific Title of Study
|
Evaluation of the Role of Causative Factors of Prana and Vyana Vayu Vitiation in the Etiopathogenesis of Primary Hypertension : A Case-Control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachee Chaporkar |
| Designation |
MD Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri. Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, 4th floor, Dr. D. Y. Patil College of Ayurved And Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7276990471 |
| Fax |
|
| Email |
pracheec5642@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital R Rasane |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, 4th floor, Dr. D. Y. Patil College of Ayurved And Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9503330831 |
| Fax |
|
| Email |
shital.rasane@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prachee Chaporkar |
| Designation |
MD Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
| Address |
Department of Ayurved Samhita Evam Siddhant, 4th floor, Dr. D. Y. Patil College of Ayurved And Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7276990471 |
| Fax |
|
| Email |
prachee5642@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar,Pimpri colony, Pimpri Chinchwad, Pune - 411018, India |
|
|
Primary Sponsor
|
| Name |
Prachee Chaporkar |
| Address |
Department of Ayurved Samhita Evam Siddhant, 4th floor, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad,411018, Pune, India |
| 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 |
| Prachee Chaporkar |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune |
OPD No 5, Department of Kayachikitsa and OPD No 7, Department of Swasthvritta, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad
Pune
MAHARASHTRA |
7276990471
pracheec5642@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DYPCA & 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 |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Case group - Diagnosed cases of Primary (Essential) Hypertension within the last 3 years, irrespective of stage.
Control group - Age and gender matched individuals with no history of hypertension or any cardiovascular disease. |
|
| ExclusionCriteria |
| Details |
For both Case and Control group -
1. Secondary Hypertension
2. Conditions like Sleep apnea, Congenital heart defect,
3. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will identify the Ayurveda based Nidana of Primary Hypertension related to dysfunction of Vata with special refernce to Prana and Vyana |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tool will be developed to assess the etiological factors related to Prana & Vyana Vayu vitiation that can serve as the standardized assessment questionnaire for future studies. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
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)
|
01/04/2026 |
| 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="0"
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
|
The case-control study will be conducted on total 265 participants, in which cases and controls will be allocated in 1:1 ratio. The study will be conducted by developing and validating a standardized questionnaire at the beginning, followed by recruitment of participants based on inclusion and exclusion criteria in both the cases and controls group respectively. The data will be collected using the developed questionnaire through interview method. Data obtained will then be classified and tabulated for both groups and appropriate statistical test will be applied to analyze the data. The obtained results will be used to derive the final outcome of the study. |