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CTRI Number  CTRI/2025/10/096707 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to evaluate the effect of individualized homeopathic medicines compared with a placebo in treating adults with early-stage (Stage I) high blood pressure. 
Scientific Title of Study   Efficacy of Individualized Homoeopathic Medicines In The Treatment Of Stage-I Essential Hypertension In Adults : A Double Blind, Randomized, Placebo_ Controlled Trial 
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 RESHMI KHATUN 
Designation  BHMS 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Sailen Manna Sarani, Doomurjala, Howrah-711104

Haora
WEST BENGAL
711104
India 
Phone  7001454370  
Fax    
Email  reshmibhms@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Saptarshi Choudhury 
Designation  Professor and Head department of Practice Of Medicine 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Sailen Manna Sarani, Doomurjala, Howrah-711104

Haora
WEST BENGAL
711104
India 
Phone  9836080877  
Fax    
Email  drcsaptarshi@gmail.com  
 
Details of Contact Person
Public Query  
Name  ProfDr Saptarshi Choudhury 
Designation  professor and Head department of Practice of Medicine 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Sailen Manna Sarani, Doomurjala, Howrah-711104

Haora
WEST BENGAL
711104
India 
Phone  9836080877  
Fax    
Email  drcsaptarshi@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital. Sailen Manna Sarani, Doomurjala,Howrah-711104,West Bengal, India. 
 
Primary Sponsor  
Name  Dr Reshmi Khatun  
Address  sailen Manna sarani, Doomurjala, Howrah- 711104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reshmi Khatun  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Medicine department, post graduate room, 1st floor, room no 03, Sailen Manna sarani, Doomurjala, Howrah,711104, WB,India
Haora
WEST BENGAL 		 7001454370

reshmibhms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Identical looking Placebo  Identical looking placebo indistinguishable from intervention group along with life style modification advised (Dash diet, moderate physical exercise).Patients will be follow up for every 2 weeks up to a period of 3 month and placebo will be dispensed from pharmacy of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital.  
Intervention  Individualized Homoeopathic medicines  According homoeopathic similimum, single medicine are given in potency as per the required based on homoeopathic principles as per organon of medicine. Patients will be follow up for every 2 weeks up to a period of 3 month and also given life style modification( advised Dash diet, moderate physical exercise). Homoeopathic medicines will be dispensed from pharmacy of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Systolic Blood Pressure from (140-159) mm of Hg and Diastolic Blood Pressure from (90-99) mm of Hg.
2. Patients who have not taken any anti-hypertensive treatment.
3.Patient who can give their informed consent willingly for study and comply for regular
follow up.
 
 
ExclusionCriteria 
Details  1. Patient who had suffeing from secondary hypertension .
2.Patients suffering from any terminal illness like uncontrolled diabetes mellitus, chronic
kidney disease, diagnosed autoimmune gastritis with hyperhomocysteinaemia, who
have known heart disease like history of MI, coronary artery disease, history of cardio-
vascular accident etc.
3.Pregnant women and lactating mother and
4.Person who had history of drug/alcohol abuse. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To detect the group difference between individualized homoeopathic medicines and identical looking placebo in
systolic blood pressure (SBP) and diastolic blood pressure (DBP) in essential hypertension
stage-I.  		 After 3 months of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1.To detect the group differences of individuals becoming normotensive from stage-I essential hypertension.
2.To detect the group differences of biochemical parameters i.e., serum lipid profile, liver function test, serum urea and creatinine, serum TSH, serum FBS and PPBS.
3.To detect the group differences in Measure Yourself Outcome Profile-2 (MYMOP-2), health related quality of life.  		 after 3 months of intervention. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 2 
Date of First Enrollment (India)   10/11/2025 
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   This study is a double blind, randomized , placebo-controlled clinical trial designed to evaluate the efficacy of individualized homoeopathic medicines (IHMs) in the treatment of stage-I essential hypertension in adults. Hypertension is a leading non- communicable disease globally and a major risk factor for cardiovascular morbidity and mortality. This trial aims to compare changes in systolic and diastolic blood pressure over a 3 month period between two groups - one receiving individualized homoeopathic medicines and the other receiving identical looking placebo, measure the systolic and diastolic blood pressure in every 15 days up to 3 months. Secondary outcome include changes in biochemical parameters (lipid profile, liver and kidney function test, serum TSH, fasting and post prandial blood sugar) and health related quality of life measured by MYMOP-2 after 3 months of intervention. 
The study duration is 1 year 6 months, with a total of 120 patients enrolled using 2:1 randomization ( 80 in IHMs group and 40 in placebo-controlled group), patients will be  followed up every 2 weeks up to 3 month.
This study will be conducted in Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, utilizing its outpatient population. The findings aim to contribute to evidence-based validation of individualized homoeopathic intervention in managing stage I hypertension and improving patients quality of life.  
 
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