Hypertension, Resistant to Conventional TherapyPhase 2NCT02124473
Addition of Homeopathy in Patients With Resistant Arterial Hypertension
A Phase 2 study testing Homeopathy in people with Hypertension, Resistant to Conventional Therapy, run by Macmillan Research Group UK at 2 sites in India.
Trial summary
Resistant hypertension (RHTN) is a common clinical problem faced by both primary care clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular events and mortality compared with patients with more easily controlled hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Homeopathy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesIndia
- Study dates
- Aug 2013to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years with resistant arterial hypertension.
- Office systolic BP >140 mm Hg or diastolic BP >90 mm Hg despite being treated with at least 3 antihypertensive drugs, including a diuretic.
- Patients with diabetes or chronic kidney disease (defined as serum creatinine >133 μmol/L or proteinuria >300 mg/day) if the office BP was >130/80 mm Hg.
Who cannot join
- Severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg) who needed an immediate adjustment of treatment,
- Renal insufficiency with serum creatinine >180 μmol/L or glomerular filtration rate <40 mL/min calculated by the Modification of Diet in Renal Disease formula,15 hyperkalemia >5.4 mmol/L, hyponatremia <130 mmol/L, and porphyria;
- Pregnant or lactating women or women of fertile age not using effective contraception;
- Patients with known prior hypersensitivity to the drug Verospiron (spironolactone; Richter Gedeon Ltd) or who are currently using any aldosterone antagonist.
Trial locations and contacts
2 sites in 1 country.
India2 sites
NMP Medical Research Institute
Jaipur, Rajasthan, 302019
NMP Medical Research Institute
Jhunjhunūn, Rajasthan
About this study
Official title: Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Homeopathy in Resistant Arterial Hypertension
Resistant hypertension (RHTN) is a common clinical problem faced by both primary care clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular events and mortality compared with patients with more easily controlled hypertension. In addition, RHTN is often complicated by metabolic abnormalities.
Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the impact on resistant hypertension. The aim of this trial was to evaluate individualized homeopathy on BP in patients with resistant hypertension.
- Being tested
- Homeopathy, Placebo
- Keywords
- Resistant hypertension, Homeopathy, Blood pressure, Ambulatory blood pressure monitoring
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeopathyOther
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Homeopathy | Experimental | A range of homeopathic potencies were used as per the individualized requirement, decided by the treating physicians.Each dose, administered orally, (in centesimal potencies). Receives: Other: Homeopathy |
| Placebo | Placebo comparator | Placebo, identical in appearance, consisted of 83.1% ethanol in 10 ml distilled water and was served in identical amber-coloured glass vials Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime systolic and diastolic pressure
Measured: Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months
Secondary outcomes (1)
24-hour systolic and diastolic BP
Measured: Change from Baseline in 24-hour blood pressure at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Vipin Sharma, BHMS, Principal investigator, NMP Medical Research Institute, IndiaNeha Sharma, Study director, Macmillan Research Group UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124473
- Sponsor's protocol ID
- Mac/NMP 1120
- Status last verified
- Apr 2014
- First submitted
- 20 Apr 2014
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized, Double-Blind, Placebo-Controlled Trial of Homeopathy in Resistant Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02124473
- Acronym / sponsor ID
- Mac/NMP 1120
- Keywords
- Resistant hypertension, Homeopathy, Blood pressure, Ambulatory blood pressure monitoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Study start
- Aug 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Resistant hypertension (RHTN) is a common clinical problem faced by both primary care clinicians and specialists worldwide. Patients with RHTN have higher rates of cardiovascular events and mortality compared with patients with more easily controlled hypertension. In addition, RHTN is often complicated by metabolic abnormalities.
Homeopathy, although widely used in hypertension, but no study has been taken to evaluate the impact on resistant hypertension. The aim of this trial was to evaluate individualized homeopathy on BP in patients with resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Homeopathy | Experimental | Other: HomeopathyA range of homeopathic potencies were used as per the individualized requirement, decided by the treating physicians.Each dose, administered orally, (in centesimal potencies). |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, identical in appearance, consisted of 83.1% ethanol in 10 ml distilled water and was served in identical amber-coloured glass vials |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years with resistant arterial hypertension.
- Office systolic BP >140 mm Hg or diastolic BP >90 mm Hg despite being treated with at least 3 antihypertensive drugs, including a diuretic.
- Patients with diabetes or chronic kidney disease (defined as serum creatinine >133 μmol/L or proteinuria >300 mg/day) if the office BP was >130/80 mm Hg.
Key exclusion criteria (4 listed)
- Severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg) who needed an immediate adjustment of treatment,
- Renal insufficiency with serum creatinine >180 μmol/L or glomerular filtration rate <40 mL/min calculated by the Modification of Diet in Renal Disease formula,15 hyperkalemia >5.4 mmol/L, hyponatremia <130 mmol/L, and porphyria;
- Pregnant or lactating women or women of fertile age not using effective contraception;
- Patients with known prior hypersensitivity to the drug Verospiron (spironolactone; Richter Gedeon Ltd) or who are currently using any aldosterone antagonist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathy | Other | Homeopathy |
| Placebo | Other | Placebo |
Primary outcome
Daytime systolic and diastolic pressure
Time frame: Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months
1 secondary outcome
24-hour systolic and diastolic BP
Time frame: Change from Baseline in 24-hour blood pressure at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vipin Sharma, BHMS principal investigator
NMP Medical Research Institute, India
Neha Sharma study director
Macmillan Research Group UK
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Homeopathy in people with Hypertension, Resistant to Conventional Therapy, run by Macmillan Research Group UK at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime systolic and diastolic pressure (time frame: Change from Baseline in Systolic and Diastolic Blood Pressure at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2014; AzTrials last refreshed its copy on 8 Nov 2026.