| CTRI Number |
CTRI/2026/02/103482 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on the role of Homeopathic Treatment in managing high Blood pressure in age group 25 to 45 years. |
|
Scientific Title of Study
|
A prospective study on the application of dr. J. T. Kent’s twelve observations in the individualized homoeopathic management of primary hypertension in age group 25 to 45 years. |
| 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 Krupa Patel |
| Designation |
PG SCHOLAR |
| Affiliation |
Parul Institute of Homoeopathy And Research Hospital |
| Address |
Parul Institute Of Homoeopathy And Research Hospital, Room No. 403, 3rd Floor, Department of Organon of Medicine and Homoeopathic Philosophy, At Ishwarpura, P.O. Limda, Ta. Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9998336767 |
| Fax |
|
| Email |
patelkrupa3526@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khyati Lakhani |
| Designation |
HOD & Professor of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Parul Institute of Homoeopathy And Research Hospital |
| Address |
Parul Institute Of Homoeopathy And Research Hospital, Room No. 403, 3rd Floor, Department of Organon of Medicine and Homoeopathic Philosophy, At Ishwarpura, P.O. Limda, Ta. Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9924125340 |
| Fax |
|
| Email |
khyati.lakhani40535@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khyati Lakhani |
| Designation |
HOD & Professor of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Parul Institute of Homoeopathy And Research Hospital |
| Address |
Parul Institute Of Homoeopathy And Research Hospital, Room No. 403, 3rd Floor, Department of Organon of Medicine and Homoeopathic Philosophy, At Ishwarpura, P.O. Limda, Ta. Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9924125340 |
| Fax |
|
| Email |
khyati.lakhani40535@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Homoeopathy And Research |
| Parul Institute of Homoeopathy And Research Hospital,Ta. Waghodia, Dist. Vadodara, State. Gujrat, India, Pin code. 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Homoeopathy And Research Hospital |
| Address |
Parul Institute of Homoeopathy And Research Hospital, At Ishwarpura, P.O. Limda, Ta. Waghodia, Dist. Vadodara-391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Krupa Patel |
Parul Institute Of Homoeopathy And Research Hospital, Room No. 403, 3rd Floor, Department of Organon of Medicine and Homoeopathic Philosophy, At Ishwarpura, P.O. Limda, Ta. Waghodia |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKrupa Patel |
Parul Institute of Homoeopathy And Research Hospital |
Parul Institute of Homoeopathy And Research Hospital, At Ishwarpura, P.O. Limda, Ta. Waghodia, Dist. Vadodara-391760
Vadodara
GUJARAT |
9998336767
patelkrupa3526@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine in 30, 200, 1M potency, BD Or TDS for 15 Days for 3 Months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Systolic blood pressure greater than 140 mmhg and
Diastolic blood pressure greater than 90 mmhg
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Stage 2 hypertension: especially if greater than 160 By 100 mmhg, stage 3 hypertension if greater than 180 By 110 mmhg
Patients on regular antihypertensive medication
Presence of other chronic diseases, history of major cardiovascular events
Dr.kents 1, 6, 7, 8, 9 observations
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the utility of application of Dr. J. T. Kent’s twelve observations in the individualized homoeopathic management of primary hypertension in age group 25 to 45 Years. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the utility of Kent Observation–Based Case Response Scale (K-Ocrs) in the individualized homoeopathic management of primary hypertension in age group 25 to 45 Years. |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/03/2026 |
| 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="0"
Months="11"
Days="30" |
|
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
|
Primary hypertension is one of the most common chronic lifestyle disorders globally and is a significant risk factor for cardiovascular morbidity and mortality. It is characterized by persistently elevated blood pressure without any identifiable secondary cause.
Primary hypertension, also called essential hypertension, accounts for approximately 90–95% of all hypertension cases.
Homoeopathy, with its individualized approach, can help in the management of primary hypertension. Dr. James Tyler Kent’s Twelve Observations provide clear guidelines to assess the patient’s response after the administration of the remedy that the case is progressing favorably or unfavorably. It enhances clinical decision-making throughout the course of treatment.
Existing research points out that applicability of the Dr.Kent’s Twelve Observations to understand prognosis and to decide second prescription. There is a need for evaluating Dr.Kent’s Twelve Observations in condition-specific guidelines, particularly for primary hypertension in younger adults. |