| CTRI Number |
CTRI/2025/07/090771 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of Homoeopathic Medicines in the Management of elevated BP, stage-I hypertension |
|
Scientific Title of Study
|
Evaluation of Individualized Homoeopathic Medicines in the Management of elevated BP, stage-I hypertension and associated biochemical markers – A Randomized, Double-blind, Placebo-controlled clinical study |
| 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 Pankhuri Misra |
| Designation |
Research Officer (Homoeoapthy)-S1 |
| Affiliation |
Dr.D.P. Rastogi Central Research Institute for Homoeopathy |
| Address |
Dr.D.P. Rastogi Central Research Institute for Homoeopathy, A-1/1, Opp. HCL, Sec-24, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8375089437 |
| Fax |
|
| Email |
drpankhccrh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankhuri Misra |
| Designation |
Research Officer (Homoeoapthy)-S1 |
| Affiliation |
Dr.D.P. Rastogi Central Research Institute for Homoeopathy |
| Address |
Dr.D.P. Rastogi Central Research Institute for Homoeopathy, A-1/1, Opp. HCL, Sec-24, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8375089437 |
| Fax |
|
| Email |
drpankhccrh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankhuri Misra |
| Designation |
Research Officer (Homoeoapthy)-S1 |
| Affiliation |
Dr.D.P. Rastogi Central Research Institute for Homoeopathy |
| Address |
Dr.D.P. Rastogi Central Research Institute for Homoeopathy, A-1/1, Opp. HCL, Sec-24, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8375089437 |
| Fax |
|
| Email |
drpankhccrh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, Opp-D Block, Janakpuri Institutional Area, New Delhi- 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Opp-D Block, Janakpuri Institutional Area, New Delhi- 110058, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr James Michael |
Clinical Research Unit (Homoeopathy), Aizawl |
3rd Floor, Ayush OPD Building, Civil hospital, Dawrpui, Aizawl, Mizoram, 796001
Aizawl
MIZORAM |
9958994325
jamesccrh@gmail.com |
| Dr Hanuman Choudhary |
Clinical Research Unit for Homoeopathy, Goa |
Old Goa Institute of Management, Ribander Campus, Goa-403006
North Goa
GOA |
9462279933
drhrchoudhary@gmail.com |
| Dr Pankhuri Misra |
Dr. D.P. Rastogi Central Research Institute, Homoeopathy, Noida |
A-1/1, Opp. HCL, Sector-24, Noida, Uttar Pradesh-201301
Gautam Buddha Nagar
UTTAR PRADESH |
8375089437
drpankhccrh@gmail.com |
| Dr Birendra Singh Rawat |
Regional Research Institute for Homoeopathy, Navi Mumbai |
Plot no. 38 and 39, Sector 18, Kharghar, Navi mumbai
Mumbai
MAHARASHTRA |
8080483012
rawatdrbirendrasingh@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Institutional Ethical Committee |
Approved |
| Regional Institutional Ethical Committee |
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 |
1-2 globule/s of indicated medicine in LM potency is to be dissolved in 120 ml of dist. water. Add 10 drops of rectified spirit and give 10 downward strokes. Make 16 doses.
Dose: 01 tsp at a time after 10 succussions
Dosage form: liquid
Route of Administration: Oral
Time of Administration : Once or twice daily on an empty stomach, as decided by the physician.
Duration of intervention: 12 months
|
| Comparator Agent |
Placebo |
1-2 non-medicated globule/s is to be dissolved in 120 ml of dist. water. Add 10 drops of rectified spirit and give 10 downward strokes. Make 16 doses.
Dose: 01 tsp at a time after 10 succussions
Dosage form: liquid
Route of Administration: Oral
Time of Administration : Once or twice daily on an empty stomach as decided by the physician.
Duration of intervention: 12 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of either sex aged between 20 and 60 years
Participants diagnosed with elevated BP between 120 and 129 or less than 80 mm Hg or Stage 1 hypertension with systolic BP between 130 and 139 mm Hg or diastolic between 80 and 89 mm Hg as per the American College of Cardiology or American Heart Association 2017
Willing and able to participate for 3 months
|
|
| ExclusionCriteria |
| Details |
Participants who are already on hypertensive medications.
Participants who have a history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, congestive cardiac failure, Stroke, or Severe Arrhythmia in the last 6 months.
Participants with Stage-2 hypertension greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic, as per the American College of Cardiology or American Heart Association 2017.
Participants with concurrent Hepatic Dysfunction defined as AST and or ALT greater than 2 times the upper standard limit or Renal Dysfunction defined as S. creatinine greater than 1.2mgdl, uncontrolled diabetes mellitus HbA1C greater than 8, uncontrolled Pulmonary Dysfunction asthmatic and COPD patients, or significant systemic illness necessitating long term drug treatment Rheumatoid arthritis, Neurological disorders, Endocrinal disorders, etc.) or Known cases of malignancy.
Women who are planning for conception or pregnancy or lactating.
Participants with history of hypersensitivity to homeopathic medicines or any doses form.
Participants taking homoeopathic medicines for any other diseases in the last 2 weeks.
Any other condition that the PI thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary:
1.Changes from baseline systolic and diastolic blood pressure measurements.
2.Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT),
Amyloid-A, Homocysteine, Interleukin -6, and CRP.
|
Changes from baseline systolic and diastolic blood pressure measurements.
[Time frame: During every follow-up of 15 days for the period of 12 months]
Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT),
Amyloid-A, Homocysteine, Interleukin -6, and CRP.
[Time frame: Baseline, 3 months, 6 months, 9 months and 12 months]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the SF-36-Health Survey Score.
Changes in the level of serum cholesterol, triglyceride, and HbA1C.
Change in the ORIDL Score.
|
Change in the SF-36-Health Survey Score.
[Time frame: Monthly for 12 months.]
Changes in the level of serum cholesterol, triglyceride, and HbA1C [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months]
Change in the ORIDL Score.
[Time frame: During every follow-up of 15 days for the period of 12 months]
|
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
03/11/2025 |
| 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="2"
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
|
The title of the study is Evaluation of Individualized Homoeopathic Medicines in the Management of elevated BP stage-I hypertension and associated biochemical markers A Randomized Double-blind Placebo-controlled clinical study. Aim of the study is to assess the clinical efficacy of Individualized Homoeopathic Medicines in the management of elevated BP, stage-I hypertension (American College of Cardiology- 2017) and to evaluate the effect of Homoeopathic medicines on the level of circulating Biochemical markers. The study design is randomized, double-blind, placebo-controlled trial. The study duration 2 years and 6 months. The objectives of the study are To assess the clinical efficacy of Individualized Homoeopathic Medicines in the management of elevated BP, stage-I hypertension (ACC 2017 To assess the changes in both systolic and diastolic blood pressure. To assess the changes in the level of biochemical parameters (HLDF 24 peptide, TNF superfamily 14 (LIGHT), Amyloid-A, Homocysteine, Interleukin -6, and CRP).Secondary Objectives To assess the changes in the total and individual domain scores of the SF-36 Health survey score To assess the changes in the level of serum cholesterol, triglyceride, and HbA1C. To assess the changes in the ORIDL scores in every follow-up. the sample size of the study is 280. Outcome Measures Primary Changes from baseline systolic and diastolic blood pressure measurements.Time frame During every follow-up of 15 days for the period of 12 month Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT) Amyloid-A, Homocysteine, Interleukin -6, and CRP. [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months Secondary Change in the SF-36-Health Survey Score. Time frame Monthly for 12 months. Changes in the level of serum cholesterol, triglyceride, and HbA1C Time frame Baseline, 3 months, 6 months, 9 months and 12 months Change in the ORIDL Score. Time frame During every follow-up of 15 days for the period of 12 months]
|