Essential HypertensionPhase 2NCT02419235
The Effect of a Homoeopathic Complex on Blood Pressure in Refractory Hypertension
A Phase 2 study testing 20% ethanol and Homoeopathic complex in people with Essential Hypertension, run by University of Johannesburg at 1 site in South Africa.
Trial summary
Refractory hypertension is defined as failure to reach goal blood pressure control in patients who are adherent to full doses of the appropriate drug regime. Hypertension results in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it the number one attributable risk for death… Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- 20% ethanol and Homoeopathic complex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2014to Mar 2015
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are male or female, between the ages of 35-60 years;
- have a systolic blood pressure between 140 mmHg-160 mmHg;
- have a diastolic blood pressure between 90 mmHg-99 mmHg; and
- are on 3 or more conventional anti-hypertensive medications of different drug classes, one of which must be a diuretic.
Who cannot join
- Have a systolic blood pressure < 140 mmHg; > 160 mmHg;
- have a diastolic blood pressure < 90 mmHg; > 99 mmHg;
- are pregnant or lactating;
- are on any other herbal or homoeopathic medicine for the treatment of hypertension;
- have secondary organ damage from hypertension; and or
- suffer from chronic conditions such as severe cardiac disease, renal failure, malignant hypertension or diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Johannesburg
Johannesburg, Gauteng, 2028
About this study
Official title: The Effect of a Homoeopathic Complex (Amylenum Nitrosum 6CH, Crataegus Oxyacantha 6CH, Natrum Muriaticum 6CH and Scutellaria Lateriflora 6CH) on Blood Pressure in Refractory Hypertension
Refractory hypertension is defined as failure to reach goal blood pressure control in patients who are adherent to full doses of the appropriate drug regime. Hypertension results in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it the number one attributable risk for death throughout the world. Conventional treatment involves lifestyle modification and antihypertensive drug therapy; however blood pressure can remain uncontrolled despite these treatment options. Previous studies have demonstrated a reduction in blood pressure in adults with essential hypertension with the use of various homoeopathic complexes. There has been no research done to date on the effect of the homoeopathic combination of Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH in adults with refractory hypertension.
The aim of the study is to investigate the effect of a homoeopathic complex Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH on blood pressure in adults with refractory hypertension, by means of blood pressure readings.
Read the detailed description
This study is a six week, double-blind, placebo-controlled pilot study. Thirty participants, aged 35 to 60 years, who have been previously diagnosed by their healthcare provider with refractory hypertension, will be recruited by means of purposive sampling. Adverts will be placed at the University of Johannesburg (UJ) Doornfontein campus and the Soweto satellite clinic Nanga Vutshilo Community Centre.
Potential participants that respond to the advert will attend an initial consultation and will be requested to sign a Participant Information and Consent Form once they agree to participate in the study. The medical history and physical examination (including vital signs, fundoscopic exam, cardiovascular exam, respiratory exam and urinalysis) will be recorded on a Case Form. Blood pressure (BP) readings will be taken on each arm with a manual BP cuff, according to standard operating procedures, on the first three consecutive days to confirm inclusion into the study. Individuals with secondary organ damage from hypertension will be excluded from the study.
Those participants that qualify for the study will be placed into two groups. One group will receive a 50ml bottle of the homoeopathic complex and the other group a 50ml bottle of placebo. Participants will receive an Intake Diary, to be completed daily, recording compliance and any adverse symptoms or aggravations that may be experienced. Follow-up consultations will take place every 7 days and participants will be requested to bring with their medication bottles for further assessment of compliance; BP readings will be recorded on a data collection form. All participants will be given the Dietary Approaches to Stop Hypertension (DASH) eating plan at the end of the study to help control their hypertension. Additionally, participants will be given an information leaflet to give to their healthcare provider, detailing the study.
Data will be analysed using the non-parametric methods: inter-group analysis will be conducted using SPSS v18 with the Mann-Whitney U-test; intra-group analysis will be done using the Friedman and the Wilcoxon-Signed Ranks tests.
A possible outcome of this study is that the homoeopathic complex will have a normalizing effect on BP readings compared to placebo. Regardless of the outcome, this study will contribute to our knowledge on the use of homoeopathic complex remedies in the treatment and management of refractory hypertension.
- Conditions
- Essential Hypertension
- Being tested
- 20% ethanol, Homoeopathic complex
- Keywords
- Refractory hypertension, Homoeopathy, Homoeopathic complex, Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH, Scutellaria lateriflora 6cH
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% ethanolOther
Also called 20% alcohol
Unmedicated 20% ethanol.
Homoeopathic complexOther
20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrium muriaticum 6cH and Scutellaria lateriflora 6cH.
| Study group | Role | What they receive |
|---|---|---|
| 20% Ethanol | Placebo comparator | Ten drops of unmedicated 20% ethanol must be administered under the tongue, three times per day, thirty minutes before or after meals, for six weeks. Receives: Other: 20% ethanol |
| Homoeopathic complex | Experimental | Ten drops of 20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH will be administered under the tongue, three times per day, thirty minutes before or after meals, for six weeks. Receives: Other: Homoeopathic complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly blood pressure measurements using a Dura Shock Handheld Aneroid sphygmomanometer model DS55
Blood pressure will be monitored in the left and right arm of each participant with a Dura Shock Handheld Aneroid sphygmomanometer model DS55, which will be correctly calibrated. An obese BP cuff will be used for overweight participants to ensure reliable results. Blood pressure measurements will be conducted according to standard operating procedures.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr J. Pellow, University of Johannesburg
- Investigators
- Janice Pellow, M.TechHom, Study director, University of Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419235
- Sponsor's protocol ID
- NangamsoBavuma200907364
- Status last verified
- May 2016
- First submitted
- 4 Apr 2015
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Homoeopathic Complex (Amylenum Nitrosum 6CH, Crataegus Oxyacantha 6CH, Natrum Muriaticum 6CH and Scutellaria Lateriflora 6CH) on Blood Pressure in Refractory Hypertension
- ClinicalTrials.gov ID
- NCT02419235
- Acronym / sponsor ID
- NangamsoBavuma200907364
- Conditions
- Essential Hypertension
- Keywords
- Refractory hypertension, Homoeopathy, Homoeopathic complex, Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH, Scutellaria lateriflora 6cH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Apr 2015 (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.
Refractory hypertension is defined as failure to reach goal blood pressure control in patients who are adherent to full doses of the appropriate drug regime. Hypertension results in 7.6 million deaths annually and 92 million disability adjusted years worldwide, making it the number one attributable risk for death throughout the world. Conventional treatment involves lifestyle modification and antihypertensive drug therapy; however blood pressure can remain uncontrolled despite these treatment options. Previous studies have demonstrated a reduction in blood pressure in adults with essential hypertension with the use of various homoeopathic complexes. There has been no research done to date on the effect of the homoeopathic combination of Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH in adults with refractory hypertension.
The aim of the study is to investigate the effect of a homoeopathic complex Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH on blood pressure in adults with refractory hypertension, by means of blood pressure readings.
Detailed description
This study is a six week, double-blind, placebo-controlled pilot study. Thirty participants, aged 35 to 60 years, who have been previously diagnosed by their healthcare provider with refractory hypertension, will be recruited by means of purposive sampling. Adverts will be placed at the University of Johannesburg (UJ) Doornfontein campus and the Soweto satellite clinic Nanga Vutshilo Community Centre.
Potential participants that respond to the advert will attend an initial consultation and will be requested to sign a Participant Information and Consent Form once they agree to participate in the study. The medical history and physical examination (including vital signs, fundoscopic exam, cardiovascular exam, respiratory exam and urinalysis) will be recorded on a Case Form. Blood pressure (BP) readings will be taken on each arm with a manual BP cuff, according to standard operating procedures, on the first three consecutive days to confirm inclusion into the study. Individuals with secondary organ damage from hypertension will be excluded from the study.
Those participants that qualify for the study will be placed into two groups. One group will receive a 50ml bottle of the homoeopathic complex and the other group a 50ml bottle of placebo. Participants will receive an Intake Diary, to be completed daily, recording compliance and any adverse symptoms or aggravations that may be experienced. Follow-up consultations will take place every 7 days and participants will be requested to bring with their medication bottles for further assessment of compliance; BP readings will be recorded on a data collection form. All participants will be given the Dietary Approaches to Stop Hypertension (DASH) eating plan at the end of the study to help control their hypertension. Additionally, participants will be given an information leaflet to give to their healthcare provider, detailing the study.
Data will be analysed using the non-parametric methods: inter-group analysis will be conducted using SPSS v18 with the Mann-Whitney U-test; intra-group analysis will be done using the Friedman and the Wilcoxon-Signed Ranks tests.
A possible outcome of this study is that the homoeopathic complex will have a normalizing effect on BP readings compared to placebo. Regardless of the outcome, this study will contribute to our knowledge on the use of homoeopathic complex remedies in the treatment and management of refractory hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% Ethanol | Placebo comparator | Other: 20% ethanolTen drops of unmedicated 20% ethanol must be administered under the tongue, three times per day, thirty minutes before or after meals, for six weeks. |
| Homoeopathic complex | Experimental | Other: Homoeopathic complexTen drops of 20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrum muriaticum 6cH and Scutellaria lateriflora 6cH will be administered under the tongue, three times per day, thirty minutes before or after meals, for six weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are male or female, between the ages of 35-60 years;
- have a systolic blood pressure between 140 mmHg-160 mmHg;
- have a diastolic blood pressure between 90 mmHg-99 mmHg; and
- are on 3 or more conventional anti-hypertensive medications of different drug classes, one of which must be a diuretic.
Key exclusion criteria (6 listed)
- Have a systolic blood pressure < 140 mmHg; > 160 mmHg;
- have a diastolic blood pressure < 90 mmHg; > 99 mmHg;
- are pregnant or lactating;
- are on any other herbal or homoeopathic medicine for the treatment of hypertension;
- have secondary organ damage from hypertension; and or
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 |
|---|---|---|
| 20% ethanolAlso: 20% alcoholUnmedicated 20% ethanol. | Other | 20% Ethanol |
| Homoeopathic complex20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrium muriaticum 6cH and Scutellaria lateriflora 6cH. | Other | Homoeopathic complex |
Primary outcome
Weekly blood pressure measurements using a Dura Shock Handheld Aneroid sphygmomanometer model DS55
Time frame: 6 weeks
Blood pressure will be monitored in the left and right arm of each participant with a Dura Shock Handheld Aneroid sphygmomanometer model DS55, which will be correctly calibrated. An obese BP cuff will be used for overweight participants to ensure reliable results. Blood pressure measurements will be conducted according to standard operating procedures.
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 17 May 2016.
- Individual participant dataSharing planned: No
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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.
Janice Pellow, M.TechHom study director
University of Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 20% ethanol and Homoeopathic complex in people with Essential Hypertension, run by University of Johannesburg at 1 site in South Africa.
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 4 inclusion and 6 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
Weekly blood pressure measurements using a Dura Shock Handheld Aneroid sphygmomanometer model DS55 (time frame: 6 weeks). 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 17 May 2016.