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CTRI Number  CTRI/2025/07/090537 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Management of Resistant Hypertension through Homoeopathy 
Scientific Title of Study   Evaluating Homoeopathy as an Add-On Treatment to Standard Care in The Management of Resistant Hypertension and Cardiovascular Protection: A Randomized, Double Blind, Controlled, Exploratory, Feasibility 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 Abhijit Chatterjee 
Designation  Professor and Head Department of Materia medica, Sumandeep Homoeopathic Medical College and Hospital 
Affiliation  Sumandeep Vidyapeeth Deemed to be University 
Address  Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara -391760, Gujarat, India

Vadodara
GUJARAT
391760
India 
Phone  9664560693  
Fax    
Email  chatterjeedrabhijit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varanasi Roja 
Designation  Research Officer(H)/ Scientist-4 
Affiliation  Central Council for Research in Homoeopathy 
Address  Room no. 315, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi – 110058, India

Central
DELHI
110058
India 
Phone  9999454036  
Fax    
Email  varanasiroja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Varanasi Roja 
Designation  Research Officer(H)/ Scientist-4 
Affiliation  Central Council for Research in Homoeopathy 
Address  Room no. 315, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homoeopathy Anusandhan Bhawan 61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi – 110058, India

Central
DELHI
110058
India 
Phone  9999454036  
Fax    
Email  varanasiroja@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy, New Delhi, India 
Address  61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi – 110058, India  
Type of Sponsor  Research institution 
 
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 Abhijit Chatterjee  Sumandeep Vidyapeeth Medical College and Hospital  Room no.1, OPD of Materia Medica Department, Block no.5, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia, Vadodara -391760, Gujarat, India
Vadodara
GUJARAT 		 9664560693

chatterjeedrabhijit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SumandeepVidyapeethInstitutionalEthicsCommittee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I131||Hypertensive heart and chronic kidney disease without heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathy and Standard care  All participants in this group shall receive individualized homoeopathic treatment along with standard care  
Comparator Agent  Placebo and Standard care   All participants in this group will receive placebo and standard care. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Known case of resistant hypertension (Individuals having BP more than or equal to systolic 140mmHg and diastolic 90mmHg in those without diabetes mellitus or chronic kidney disease and more than or equal to systolic 130mmHg and diastolic 80mmHg in those with diabetes mellitus or chronic kidney disease despite the use of at least three antihypertensive drugs of different substance classes, including a diuretic at maximum tolerated doses)
2.Confirmation to the adherence to anti-hypertensive medication as assessed by Morisky Medication Adherence Scale-8(MMAS-8).
3.Participants aged between 40 to 75 years of age.
4.Both the genders.
5.Participants having controlled diabetes (HbA1c less than 7.5 to 8 percent).
6.Participants with mild and moderate chronic kidney disease, stages G2-G3a (GFR more than 45 to less than 90 mg per mmol)
7.Voluntary written informed consent.
8.Able to comply with the study protocol.
 
 
ExclusionCriteria 
Details  1. Participants with history of stroke or transient ischemic attack or hypertensive encephalopathy or acute coronary syndrome or hospitalization for heart failure in the past 6 months.
2. Participants with known secondary hypertension.
3. Known participant of stage III and stage IV chronic heart failure.
4. Participants with chronic kidney disease (Stages G3b, G4, G5).
5. Participants who had undergone any major surgery in the past 6 months.
6. Pregnant ladies and breastfeeding mothers.
7. Participants with known mental ailments like schizophrenia and other psychotic conditions.
8. Participants with known systemic illness like cancer, HIV, genetic disorders etc.
9. Participants having any clinically relevant medical or surgical condition, that in the opinion of the investigator would put the person at risk by participating in the study.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the changes in blood pressure (SBP/DBP) values over 6 months.   Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the changes in the quality of life using SF-36 questionnaire among the two groups at baseline and at month 6.   Baseline and Month 6.  
To assess the compliance related to diet and physical activity using H-SCALE questionnaire among the two groups over the period of 6 months.  Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6. 
To assess the changes in biochemical markers like blood glucose profile, lipid profile, liver function test, kidney function test, microalbumin, c-reactive protein at baseline and at month 6.
 		 Baseline and Month 6.  
To assess the changes in cardiac biomarker like cardiac troponin at baseline and at month 6.  Baseline and Month 6.  
To assess the changes in ECG and CVD measures like baroreflex sensitivity (BRS) to quantify the influence of baroreflex on heart rate, HF-HRV to assess vagally mediated modulation of heart rate, FMD to evaluate endothelial function, PWD to assess arterial stiffness and LV mass to characterize left ventricular structure at baseline and at month 6.
 		 Baseline and Month 6.  
To assess the reduction of standard care drugs among the two groups over the period of 6 months.  Baseline and Month 6.  
To assess the proportion of participant achieving goal approach of SBP/DBP less than 140/90 mmHg for those without diabetes mellitus or chronic kidney disease and less than 130/80mmHg for those with diabetes mellitus or chronic kidney disease at month 6.
 		 Baseline and Month 6.  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   30/09/2025 
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="3"
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   The prolonged condition of Resistant Hypertension can lead to adverse kidney outcomes, cardiac morbidity and other systemic changes, which points out the necessity for its treatment. This study shall evaluate the efficacy of Individualized Homoeopathic medicines as an add-on treatment to standard care in the management of Resistant Hypertension. It is a randomized, double blind, controlled, exploratory, feasibility trial and the Cardiovascular Protection is also assessed in the secondary outcome. The study shall be conducted at Sumandeep Vidyapeeth Deemed to be University, SVDU in collaboration with Central Council for Research in Homoeopathy, CCRH. Total one hundred participants shall be enrolled in this study, with 50 in each arm. The inclusion criteria include participants of both the gender, male and female, aged between 40-75years with known resistant hypertension condition and being adherent to its standard care. The adherence of the participants shall be assessed with Morisky Medication Adherence Scale, MMAS-8. Participants having controlled diabetes with HbA1c less than 7.5 - 8 percent and participants with mild and moderate chronic kidney disease i.e. stages G2-G3a (GFR between 45 to 90 mg/mmol) shall aso be considered into the study. Only the participants with voluntary written consent and ability to comply with the study protocol shall be enrolled. Participants in one arm shall be given Individualized homoeopathic medicine along with the standard care and in the other arm shall be given placebo along with the standard care. The primary objective is to determine the effectiveness of homoeopathy as an add-on treatment to standard care in the management of patients with resistant hypertension with changes in blood pressure (SBP/DBP) values over 6 months. Participants with co-morbidities shall be allowed to continue their previous medications prescribed by the conventional physician in the follow-up and can withdraw from the study at any time for any reason if they wish to do so without any consequences. This study shall be conducted according to the standards of Good Clinical Practice in India and in accordance with the requirements of the Declaration of Helsinki.  
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