| CTRI Number |
CTRI/2026/04/107799 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of JH Allen miasmatic analysis in the management of Essential Hypertension |
|
Scientific Title of Study
|
Utility of individualized homoeopathic medicine in the
management of
Essential Hypertension including miasmatic analysis based on J H Allen |
| 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 Varun Tyagi |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8178650511 |
| Fax |
|
| Email |
varuncoooltyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vijay Kumar Pushkar |
| Designation |
Principal |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9415466529 |
| Fax |
|
| Email |
vijay04pushkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Tyagi |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8178650511 |
| Fax |
|
| Email |
varuncoooltyagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College And Hospital Viraj Khand Gomti Nagar Lucknow 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Varun Tyagi |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College And Hospital Viraj Khand Gomti Nagar Lucknow 226010 |
| 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 Varun Tyagi |
State National Homoeopathic Medical College And Hospital Lucknow |
OPD-1 Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College And Hospital Viraj Khand Gomti Nagar Lucknow 226010
Lucknow
UTTAR PRADESH |
8178650511
varuncoooltyagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College And Hospital Lucknow |
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 medicines |
Participants with essential hypertension fulfilling inclusion and exclusion criteria will receive individualized homoeopathic medicines selected on the basis of totality of symptoms and miasmatic analysis as per John Henry Allen after detailed case taking including mental generals physical generals particulars past and family history and clinical examination with blood pressure measurement Medicines will be prescribed in potencies of 30C 200C 1M or 10M administered orally in the form of globules Dose will consist of 2 to 4 globules per administration Frequency will be single dose or repeated at intervals depending on individual response and remedy nature Duration of treatment will be 6 months with regular follow up every 15 days for monitoring blood pressure and clinical status and repetition of dose as required Outcome assessment will include blood pressure and quality of life using WHO QOL scale |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients suffering from essential hypertension
pre hypertensives SBP 120 to 139 mm Hg and DBP 80 to 89 mm Hg and stage I hypertensives SBP 140 to 159 mm Hg and DBP 90 to 99 mm Hg
2 Whose history examination and routine investigations revealed no evidence of obvious secondary causes
3 Patients who are willing for inclusion in the study and giving consent to participate and willing for regular follow ups |
|
| ExclusionCriteria |
| Details |
1 Pregnant or lactating women with essential hypertension
2 Patients with severe essential hypertension
3 Patients with secondary hypertension
4 Patients who require emergency medical interventions or Severe Co morbidities. Simultaneous participation in other clinical studies or completion of Participation in a study less than 6 months prior
5 Patients with autoimmune disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Blood pressure of the Patient shall be recorded in each follow up in the Blood Pressure Chart to assess the effectiveness of the medicine prescribed |
Baseline to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life will be assessed using the WHO QOL questionnaire covering four domains. Baseline and follow up scores will be compared to evaluate improvement in general health |
Baseline to 6 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)
|
07/04/2026 |
| 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="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
|
Essential hypertension is a major public health problem and a leading risk factor for cardiovascular morbidity and mortality. This study aims to evaluate the utility of individualized homoeopathic medicines in the management of essential hypertension using miasmatic analysis based on J H Allen. It is a prospective single arm open label interventional study to be conducted. Thirty patients aged 25 to 60 years diagnosed with essential hypertension pre hypertension and Stage I will be enrolled as per inclusion and exclusion criteria. Individualized homoeopathic medicines will be prescribed in centesimal potency based on detailed case taking and miasmatic evaluation. Patients will be followed up every 15 days for a period of 18 months. The primary outcome measure will be change in systolic and diastolic blood pressure and the secondary outcome will be assessment of quality of life using the WHOQOL BREF questionnaire. The study intends to assess the effectiveness and potential role of individualized homoeopathic treatment in improving blood pressure control and overall quality of life in patients with essential hypertension. |