HypertensionNCT01527760
Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension
A study testing Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.) in people with Hypertension, run by Fr Muller Homoeopathic Medical College at 1 site in India.
Trial summary
To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)
- How many people
- 37 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2011to Sep 2011
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension at the range 180-120 mm of Hg for Systole \&
- 110-80 mm of Hg for Diastole
Who cannot join
- Patients who are on ACEI / ARB for Hypertension
- Diseases in which life expectancy is less than six months
- Secondary hypertension
- CHD
- Family History of Mental Illness like Anxiety or depression.
- Nasal Congestion
Trial locations and contacts
1 site in 1 country.
India1 site
Fr Muller Homoeopathic Medical College Hospital
Mangalore, Karnataka, 575018
About this study
Official title: Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension. One Group Pretest Posttest Design
To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks.
- Conditions
- Hypertension
- Being tested
- Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)
- Keywords
- Essential Hypertension, Viscum album mother tincture, one group pretest post-test study
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)Drug
Ten drops of Drug in 30 ml of distilled water with a frequency of three times a day for a duration of 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic and Diastolic blood pressure.
Measured: 12 weeks
Secondary outcomes (5)
Change in Serum Cholesterol
Measured: 12 weeks
Change in Serum Triglycerides
Measured: 12 weeks
Change in Serum LDH
Measured: 12 weeks
Change in Serum Urea
Measured: 12 weeks
change in Serum CKMB
The blood sample was collected at the end of 12 weeks of medication followed by a drug free period of 4 weeks.The blood sample was collected again at the end of 4 weeks of drug free period to ascertain serum CKMB.
Measured: 12 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fr Muller Homoeopathic Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Rajiv Gandhi University of Health Sciences
- Responsible party
- Principal investigator, Dr Kurian P J, Fr Muller Homoeopathic Medical College
- Investigators
- Dr Kurian P John, MD, Principal investigator, Fr Muller Homoeopathic Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527760
- Sponsor's protocol ID
- RGUHS2010
- Status last verified
- Feb 2012
- First submitted
- 3 Feb 2012
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poruthukaren KJ, Palatty PL, Baliga MS, Suresh S. Clinical evaluation of Viscum album mother tincture as an antihypertensive: a pilot study. J Evid Based Complementary Altern Med. 2014 Jan;19(1):31-5. doi: 10.1177/2156587213507726. Epub 2013 Nov 5.
PubMed 24647376
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Viscum Album Mother Tincture as an Anti-hypertensive in Essential Hypertension. One Group Pretest Posttest Design
- ClinicalTrials.gov ID
- NCT01527760
- Acronym / sponsor ID
- RGUHS2010
- Conditions
- Hypertension
- Keywords
- Essential Hypertension, Viscum album mother tincture, one group pretest post-test study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fr Muller Homoeopathic Medical CollegeUniversity, hospital or other
- Collaborators
- Rajiv Gandhi University of Health Sciences
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Feb 2012 (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.
To estimate the effectiveness of Viscum album Homoeopathic mother tincture in Essential Hypertension by conducting clinical trial in moderate hypertensive patients for a period of six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertension at the range 180-120 mm of Hg for Systole \&
- 110-80 mm of Hg for Diastole
Key exclusion criteria (6 listed)
- Patients who are on ACEI / ARB for Hypertension
- Diseases in which life expectancy is less than six months
- Secondary hypertension
- CHD
- Family History of Mental Illness like Anxiety or depression.
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 |
|---|---|---|
| Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)Ten drops of Drug in 30 ml of distilled water with a frequency of three times a day for a duration of 12 weeks | Drug | – |
Primary outcome
Change in Systolic and Diastolic blood pressure.
Time frame: 12 weeks
5 secondary outcomes
Change in Serum Cholesterol
Time frame: 12 weeks
Change in Serum Triglycerides
Time frame: 12 weeks
Change in Serum LDH
Time frame: 12 weeks
Change in Serum Urea
Time frame: 12 weeks
change in Serum CKMB
Time frame: 12 weeks and 16 weeks
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 16 Feb 2012.
- Derived from this study: PubMed 24647376Poruthukaren KJ, Palatty PL, Baliga MS, Suresh S. Clinical evaluation of Viscum album mother tincture as an antihypertensive: a pilot study. J Evid Based Complementary Altern Med. 2014 Jan;19(1):31-5. doi: 10.1177/2156587213507726. Epub 2013 Nov 5.
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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.
Dr Kurian P John, MD principal investigator
Fr Muller Homoeopathic Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.) in people with Hypertension, run by Fr Muller Homoeopathic Medical College at 1 site 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 2 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 16 Feb 2012. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in Systolic and Diastolic blood pressure. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01527760, which also lists 1 linked publication.
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 16 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.