| CTRI Number |
CTRI/2025/09/094729 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Managing the primary hypertension in adults with individualized dynamized homoeopathic medicine - A prospective study |
|
Scientific Title of Study
|
An interventional prospective study to ascertain the effectiveness of individualized dynamized homoeopathic medicine in cases of primary hypertension in adults using American Heart Association classification |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parekh Palak Hetankumar |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Room No.- 101, Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot, Gujarat
Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot
Rajkot
GUJARAT
393001
India |
| Phone |
9499708928 |
| Fax |
|
| Email |
kmahajan2510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Bhamar |
| Designation |
Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Room No.-101, Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot
Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9131331597 |
| Fax |
|
| Email |
shailendrabhamar615@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parekh Palak Hetankumar |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Room No.-101, Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot
Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot
Rajkot
GUJARAT
393001
India |
| Phone |
9499708928 |
| Fax |
|
| Email |
kmahajan2510@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot -360002, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Sainath Homoeopathic Hospital |
| Address |
Sainath Homoeopathic Hospital, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot |
| 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 |
| PAREKH PALAK HETANKUMAR |
Sainath Homoeopathic Hospital |
Room No.-101, Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Parul University, behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot
Rajkot
GUJARAT |
9499708928
kmahajan2510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH - RAJKOT HOMOEOPATHIC MEDICAL COLLEGE [RHMC], PARUL UNIVERSITY, GUJARAT |
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 dynamized homoeopathic medicines |
Dose - Not fixed - individualized according to each patient
Frequency - As per individualized prescription
Route of administration - oral
Total duration of intervention - 9 months to one year |
| Comparator Agent |
No comparative study |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with primary hypertension.
Patient willingness to provide informed consent.
Age group in between 30-60 years.
Not involved in another clinical trials. |
|
| ExclusionCriteria |
| Details |
Individuals with secondary hypertension due to other medical conditions (e g.- kidney diseases, thyroid disorders, diabetes).
Individuals below 30 and above 60 years of age.
Individual having mental disorders.
Woman- pregnant or continue breastfeeding
Withdrawal cases and drop out cases- not taking medicines at proper time, no further follow-ups. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in systolic and diastolic blood pressure, categorised according to American Heart Association stages before and after treatment, measured using sphygmomanometer |
15 days, 1st month, 2nd month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in quality of life |
15 days, 1st month, 2nd month & 3rd month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/09/2025 |
| 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="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
|
HYPERTENSION IS KNOWN AS "SILENT KILLER" AND CHRONIC PROGRESSIVE CONDITION AND ONE OF THE LEADING CAUSES OF ALL POSSIBLE DISEASES. IN MODERN LIFESTYLE DUE TO VARIOUS CAUSES SUCH AS NEW LIFESTYLE ADAPTATIONS, INTAKE OF FAST FOOD, HIGH SOCIETY AND SO ON. MODERN CONVENTIONAL TRATM- RELIES ON LONG TERM ANTIHYPERTENSIVE DRUGS, WHICH MAY CAUSES MANY SIDE EFFECTS. THIS PROSPECTIVE, INTERVENTIONAL, SINGLE ARM, OPEN LABEL CLINICAL STUDY AIMS TO EVALUATE THE EFFECT OF INDIVIDUALIZED DYNAMIZED HOMOEOPATHIC MEDICINE IN ADULTS AGED 30-60 YEARS DIAGNOSED WITH PRIMARY HYPERTENSION, CLASSIFIED AS PER AMERICAN HEART ASSOCIATION. 50 PATIENTS FULFILLING THE INCLUSION CRITERIA WILL BE RECRUITED THROUGH SIMPLE RANDOM SAMPLING. EACH PARTICIPANT WILL RECEIVE INDIVIDUALIZED DYNAMIZED HOMOEOPATHIC MEDICINE FOR 9-12 MONTHS. OUTCOMES WILL BE ASSESSED USING BLOOD PRESSURE READINGS AND SF- 36 HEALTH SURVEY TO MEASURE QUALITY OF LIFE. THE STUDY AIMS TO GENERATE EVIDENCE ON HOMOEOPATHY AS A POTENTIAL COMPLEMENTARY APPROACH FOR BETTER HYPERTENSION CONTROL AND IMPROVED PATIENT WELL- BEING |