| CTRI Number |
CTRI/2025/09/094419 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study of homoeopathic treatment in the management of essential hypertension in age group of 18 to 65 years |
|
Scientific Title of Study
|
Comparative study on individualized homoeopathic medicine using homoeopathic medical repertory as an add-on therapy versus conventional medicine in the management of essential 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 Anveksha Tukaram Thombare |
| Designation |
PG student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9579957196 |
| Fax |
|
| Email |
anvekshathombare77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Anveksha Tukaram Thombare |
| Designation |
PG student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
MAHARASHTRA
411018
India |
| Phone |
9579957196 |
| Fax |
|
| Email |
anvekshathombare77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Kulkarni |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9673423294 |
| Fax |
|
| Email |
veena.kulkarni@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of homoeopathic repertory and case taking Dr D Y homoeopathic medical college and research center sant tukaram nagar pimpri pune 411018 maharashtra India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [No sponsorship ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anveksha Thombare |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
9579957196
anvekshathombare77@gmail.com |
| Dr Anveksha Thombare |
Keshav Nagar Peripheral OPD |
Keshav Nagar Chinchwad Pune
Pune
MAHARASHTRA |
9579957196
anvekshathombare77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College and Research Centre 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicines |
Dose 200 potency Frequency TDS Route of administration Oral Total duration of intervention five months |
| Comparator Agent |
Placebo |
Dose placebo Frequency TDS Route of administration Oral Total duration of intervention 5 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from the essential hypertension
[SBP: 130-149 mmHg and DBP 90-99 mmHg].
Participants who fulfilling the diagnostic criteria for essential hypertension as defined by the 2017 guidelines.
Patient who is willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
The cases of secondary hypertension [ SBP more than 140 mmHg and DBP more than 100 mmHg].
Individual having chronic renal disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Blood Pressure
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to the end of study period (measured monthly) Comparing the effects of individualized homoeopathic medicine with conventional treatment in the management of essential hypertension. |
Reduction in Blood Pressure
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline to the end of study period (measured monthly) Comparing the effects of individualized homoeopathic medicine with conventional treatment in the management of essential hypertension.
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Repertorial analysis outcomes observation of frequently indicated rubrics and remedies in essential hypertension cases.
Need for additional or concomitant medication
reduction or continuation of antihypertensive drugs in conventional group. |
1 to 2 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/10/2025 |
| 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="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
|
The present study is a comparative clinical trial designed to evaluate the effectiveness of individualized homoeopathic medicines, selected through Murphys Homoeopathic Medical Repertory, versus conventional medicine in the management of essential hypertension. Hypertension is a significant global health burden, yet standardized guidelines for its homoeopathic management are lacking, with previous studies showing limited methodology and insufficient focus on repertorial data and mental emotional symptoms. This experimental, two group study will include 60 patients between 18 to 65 years with essential hypertension (SBP 130 to149 mmHg, DBP 90 to 99 mmHg) and will be conducted over 18 months at Dr. D.Y. Patil Homoeopathic Medical College, Pune. One group will receive individualized homoeopathic medicines with conventional medicine while the other will receive conventional treatment with placebo, with outcomes assessed through regular blood pressure monitoring and statistical analysis. The study aims to determine whether individualized homoeopathy can provide an effective, holistic, and safe alternative or complement to conventional antihypertensive therapy. |