| CTRI Number |
CTRI/2025/07/091297 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding Root Cause of Primary Hypertension with Physical and Mental Nature That is Constitution of the Patient |
|
Scientific Title of Study
|
Investigate Role of Fundamental Cause and Ascertain Constitution of the Patient in Cases of Primary 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 |
Ruta Manishbhai Changela |
| Designation |
PG Scholar |
| Affiliation |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital Department of Organon of Medicine 2nd Floor Near Navjivan Circle Udhana Magadalla Road Surat
Surat
GUJARAT
394101
India |
| Phone |
7016757676 |
| Fax |
|
| Email |
rutachangela2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asfaqahmed subedar |
| Designation |
Professor of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital Department of Organon of Medicine 2nd Floor Near Navjivan Circle Udhana Magadalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9824774456 |
| Fax |
|
| Email |
asfaqahmedsubedar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asfaqahmed subedar |
| Designation |
Professor of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital |
| Address |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital Department of Organon of Medicine 2nd Floor Near Navjivan Circle Udhana Magadalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9824774456 |
| Fax |
|
| Email |
asfaqahmedsubedar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhana Magdalla Road Surat India 395001 |
|
|
Primary Sponsor
|
| Name |
Chandravatiben dhansukhlal pachchigar college of homoeopathic medicine and hospital |
| Address |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital near Navjivan Circle Udhana Magdalla Road Surat 395001 |
| Type of Sponsor |
Private medical college |
|
|
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 Ruta Manishbhai Changela |
Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital |
Department of Organon of Medicine Post Graduation Division 2nd floor Near Navjivan Circle Udhna Magadalla Road Surat
Surat
GUJARAT |
7016757676
rutachangela2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititutional Ethical Committee of C.D Pachchigar College of Homoeopathic Medicine and Hospital |
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 |
Homoeopathic Medicine |
Homoeopathic Medicine Dose as per Requirement of case Through Sublingual Mode of Administration Within Time Duration of 9 Months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Blood Pressure in Rang of less Than or Equal to 150 by 90 mm of hg
Patient with or without Taking Antihypertensive Drug |
|
| ExclusionCriteria |
| Details |
Genetic Disorders Advance Pathology and Terminal Organic Disease
Patient With Multiple Systematic Disease with Hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study Which Fundamental Cause And Constitution Making an Individual Prone to Primary Hypertension |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understanding Which constitutional Type are More Prone to Develop Hypertension |
9 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)
|
30/07/2025 |
| 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="9"
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
|
Dissertation Synopsis Summary Title Investigate Role of Fundamental Cause and Ascertain Constitution of the Patient in Cases of Primary Hypertension Researcher Dr. Ruta Manishbhai Changela
C.D. Pachchigar Homoeopathic Medical College, Surat
Veer Narmad South Gujarat University Need for the Study Hypertension is a major global health issue, especially among adults and the elderly. Modern medicine offers only symptomatic relief with lifelong antihypertensive drugs. Homoeopathy provides a constitutional approach that can target the fundamental causes miasms lifestyle and emotional factors of the patient. The study aims to identify these underlying miasms and individual constitutions in hypertensive patients for better personalized treatment. Aim To identify the chronic miasm that is fundamental cause and constitution in primary hypertension cases and manage them homoeopathically. Objectives Identify the fundamental cause chronic miasm in primary hypertension. Ascertain the constitution of the patient. Study how constitution and miasms make an individual prone to hypertension and guide treatment. Methodology Study Design Analytical study
Sample Size 30 patients
Sampling Method Simple random sampling
Study Duration 9 months
Inclusion Criteria Patients aged 25 to 55 years and BP between 130 by 90 to 140 by 90 mmHg
Exclusion Criteria Patients with genetic disorders, multiple system diseases, or advanced pathology
Data Collection Case taking based on Organon aphorisms 83 to 104 interviews, clinical evaluation
Assessment Criteria BP improvement without antihypertensives, sustained normal range BP, or patient dropout Homoeopathic Relevance Treatment based on individual constitution and miasmatic background.
Reference to Dr. Hahnemann’s aphorism 5 for chronic disease evaluation.
Focus on lifestyle, emotional health, diet, and holistic case management. Conclusion This study intends to explore how different constitutions and miasms predispose individuals to hypertension and how tailored homoeopathic intervention can aid long-term management or potential recovery. |