| CTRI Number |
CTRI/2025/12/098310 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on homoeopathic medicines to improve quality of life in people with high blood pressure |
|
Scientific Title of Study
|
Evaluating the role of Homoeopathic medicines in improving quality of life in hypertensive patients (35-75 years): An interventional study using the MINICHAL Scale |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ambica Tomar |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homoeopthic Medical College Hospital and Research Institute |
| Address |
Department of Materia Medica Sri Ganganagar Homeopathic Medical College Hospital and Research Institute near RIICO bus stand, Hanumangarh road, Sri Ganganagar, Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8006608012 |
| Fax |
|
| Email |
ambica.tomar18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charanjeet Singh |
| Designation |
Principal |
| Affiliation |
Sri Ganganagar Homoeopthic Medical College Hospital and Research Institute |
| Address |
Department of Materia Medica Sri Ganganagar Homeopathic Medical College Hospital and Research Institute near RIICO bus stand, Hanumangarh road, Sri Ganganagar, Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9414225433 |
| Fax |
|
| Email |
Sgnhh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ambica Tomar |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homoeopthic Medical College Hospital and Research Institute |
| Address |
Department of Materia Medica Sri Ganganagar Homeopathic Medical College Hospital and Research Institute near RIICO bus stand, Hanumangarh road, Sri Ganganagar, Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
8006608012 |
| Fax |
|
| Email |
ambica.tomar18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ganganagar Homeopathic Medical College Hospital and Research Institute near RIICO bus stand hanumangarh road Sri Ganganagar Rajasthan India 335002 |
|
|
Primary Sponsor
|
| Name |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
near RIICO bus stand Hanumangarh road Sri Ganganagar 335002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ambica Tomar |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
Department of Materia Medica Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus stand Hanumangarh road Sri Ganganagar Rajasthan 335002
Ganganagar
RAJASTHAN |
8006608012
ambica.tomar18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Individualized homoeopathic medicines prescribed on the basis of totality of symptoms and repertorization. Remedies selected from the institute pharmacy will be individualized for each participant. Potency and repetition will be decided case-wise as per Organon principles. Route oral. Frequency and dose as per prescribing physician judgement. Duration of intervention participants will be followed for up to 12 months with scheduled visits every 15 days. MINICHAL questionnaire will be re-administered at minimum 3 months and maximum 6 months for outcome assessment. All concomitant regular antihypertensive medications will be continued (no planned withdrawal of standard therapy). Source of remedies: Pharmacy of Sri Ganganagar Homoeopathic Medical College, Hospital & Research Institute |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 35–75 years
2. Diagnosed with primary hypertension without gross pathological complications
3. Willing to give informed consent
4. Both sexes and all socio-economic backgrounds. |
|
| ExclusionCriteria |
| Details |
1. Secondary hypertension or severe complications (e.g., chronic kidney disease,
heart failure)
2. Patients requiring emergency treatment
3. Patients with fewer than one follow-up visit
4. Psychiatric illness interfering with assessment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Quality of Life in hypertensive patients measured by MINICHAL Scale Psychological and Somatic domains |
MINICHAL scores will be assessed at baseline, at 4 weeks, at 8 weeks, and at 12 weeks (end of follow-up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in systolic & diastolic blood pressure from baseline to follow-up. |
BP will be assessed at baseline, 4 weeks, 8 weeks, & 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
12/12/2025 |
| 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
|
The study is for scientifically assessing the effectiveness of homoeopathic medicine in improving the quality of life in hypertensive patients aged 35–75 years using the validated MINICHAL scale as hypertension is a widespread chronic condition with both physiological and psychological impacts there is a need for holistic approaches to improve patient outcomes beyond mere blood pressure control it includes 96 patients chosen who are suffering from primary hypertension |