| CTRI Number |
CTRI/2025/09/094251 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathic medicines for uncontrolled high blood in menopausal women. |
|
Scientific Title of Study
|
A series of N-of-1 trials exploring the efficacy of individualized homoeopathic medicines in LM potencies along with standard of care in the treatment of resistant hypertension in post-menopausal women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1327-1144 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvashi Diwakar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital Government of West Bengal |
| Address |
Department of Homoeopathic Repertory and Casetaking OPD No PG-3 12 Gobinda Khatick Rd Tangra Kolkata West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
8130907217 |
| Fax |
|
| Email |
urvashidiwakar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Urvashi Diwakar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital Government of West Bengal |
| Address |
Department of Homoeopathic Repertory and Casetaking OPD No PG-3 12 Gobinda Khatick Rd Tangra Kolkata West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
8130907217 |
| Fax |
|
| Email |
urvashidiwakar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head, Department of Pathology and Microbiology |
| Affiliation |
D.N.De Homoeopathic Medical College and Hospital Government of West Bengal |
| Address |
Department of Homoeopathic Repertory and Casetaking OPD No PG-3 12 Gobinda Khatick Rd Tangra Kolkata West Bengal
Kolkata
WEST BENGAL
700046
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.N.De Homoeopathic Medical College and Hospital Government of West Bengal, 12 Gobinda Khatick Rd Tangra Kolkata West Bengal 700046 |
|
|
Primary Sponsor
|
| Name |
D.N.De Homoeopathic Medical College and Hospital Government of West Bengal |
| Address |
12 Gobinda Khatick Rd Tangra Kolkata West Bengal 700046 |
| Type of Sponsor |
Government 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 |
| Dr Urvashi Diwakar |
D.N.De Homoeopathic Medical College and Hospital |
Department of Homoeopathic Repertory and Case taking OPD No PG-3 12, Gobinda Khatick Road, Tangra, Kolkata, West Bengal 700046
Kolkata
WEST BENGAL |
8130907217
urvashidiwakar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D.N.De Homoeopathic Medical College and Hospital |
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 |
| Comparator Agent |
Identical looking Placebo plus Standard care with Concomittant care |
Placebo Indistinguishable solution containing 35mL of 90% alcohol is administered in the same posology as the Verum medication. Standard of care in essential hypertension involves antihypertensive medications (diuretics, ACE inhibitors, ARBs, calcium channel blockers, or beta-blockers) as per patient profile and risk factors. All the enrolled patients will receive advices on general management according to ACC guidelines emphasize a comprehensive approach for weight loss, DASH Diet, Sodium reduction, and physical activity, along with yoga postures helpful in hypertensive conditions as per guidelines of Moraji Desai National Institute of Yoga, Ministry of Ayush. |
| Intervention |
Individualized homeopathic medication plus Standard care with Concomittant care |
Individualized homeopathic medication (IHM) following the method of the sixth edition of the Organon is summarized as below: • Individualization of the homeopathic medication for each case will be based on analyzing the totality of chronic symptoms for those that stand out as characteristic of the case well defined, intense, peculiar – (Organon, 6th ed., paragraphs 95,104, 153, 154, 164). • The selection of the homeopathic medication for characteristic symptoms will be founded on a primary source of materia medica (Organon, 6th ed., paragraph 148). • The homeopathic medication will derive from standardized matrices prepared according to the method described in the sixth edition of the Organon (paragraphs 270, 271). Intervention is planned as administering individualized homeopathic medicines in 50 millesimal potencies, as decided appropriate to the case or condition. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) will be dissolved in 80ml distilled water with addition of 2 drops of 90% v/v ethanol; 15 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. All medicines and sundry items will be procured from a Good Manufacturing Practice (GMP)- certified firm. • The participant should apply ten succussions to the bottle before each dose (Organon, 6th ed., paragraph 248).
As the participant improves, the selected homeopathic medication will be further administered in “step by step” ascending fifty-millesimal potencies (LM1-LM2-LM3-LM4...), wherein each potency will be used for a maximum period of two weeks. Standard of care in essential hypertension involves antihypertensive medications (diuretics, ACE inhibitors, ARBs, calcium channel blockers, or beta-blockers) as per patient profile and risk factors. All the enrolled patients will receive advices on general management according to ACC guidelines emphasize a comprehensive approach for weight loss, DASH Diet, Sodium reduction, and physical activity, along with yoga postures helpful in hypertensive conditions as per guidelines of Moraji Desai National Institute of Yoga, Ministry of Ayush. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Postmenopausal women with age group of 45-60 yrs of age.
2. Diagnosed cases of essential hypertension with blood pressure range, Systolic: 140- 159mmhg, Diastolic: 90-99mmhg
3. Patients on concurrent use of antihypertensive medications.
|
|
| ExclusionCriteria |
| Details |
1. Failing to give written, informed consent/assent before participating
2. Postmenopausal Hypertension cases associated with complications like kidney disease, heart diseases, stroke etc. and severe concurrent illness
3. Cases with autoimmune disorders
4. Immunocompromised individuals
5. Cases with substance abuse and /or dependence.
6. Patient undergoing any hormonal replacement therapy, using contraceptive pills or history of their use in previous 3 months.
7. Those who are too ill to get consultation.
8. Diagnosed cases of uncontrolled or potentially fatal illnesses impacting quality of life, such as unstable mental or psychiatric illnesses.
9. Receiving homoeopathic treatment within the last six months for any chronic illness.
10. Concurrent involvement in any other clinical study. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in systolic blood pressure (SBP) and diastolic blood pressure (DBP) |
At Baseline every 17 days up to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mini Questionnaire of Quality of Life in Hypertension (MINICHAL) Questionnaire |
At Baseline every 17 days up to 4 months |
| Medical Outcomes Study Questionnaire Short Form 12 (SF-12) Questionnaire |
At Baseline every 17 days up to 4 months |
| Serum Urea, uric acid, creatinine, urine R/E, Lipid profile & ECG |
At Baseline every 17 days up to 4 months |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/09/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [urvashidiwakar1@gmail.com].
- For how long will this data be available start date provided 01-01-2028 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
| This study is designed whether IHMs in LM Potencies can produce any significant effect beyond placebo in systolic and diastolic blood pressures in the treatment of resistant hypertension in postmenopausal women after four months of intervention, using an N-of-1 trial design. The trial will be conducted at the Outpatient Department of D. N. De Homoeopathic Medical College and Hospital, Kolkata. Participants will receive personalized homeopathic medicines, with each treatment cycle followed by a washout phase to assess individual responses. The primary outcome is the change in systolic and diastolic blood pressure from baseline. Secondary outcomes include improvement in quality of life measured by the MINICHAL (Mini Cuestionario de Calidad de Vida en Hipertensión Arterial) and SF-12 (Short Form Health Survey) scales. Additionally, ancillary investigations—including serum urea, serum uric acid, serum creatinine, urine routine examination, lipid profile, and electrocardiogram (ECG) will be conducted to monitor end-organ damage associated with hypertension. This trial aims to assess the individualized therapeutic response to homeopathy in resistant hypertension and explore its potential as a safe, complementary approach in long-term hypertension care. | |