HemorrhagePhase 1NCT00405626
Double Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH
A Phase 1 study testing Bellis Perenis ,Arnica montana in people with Hemorrhage, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Bellis Perenis ,Arnica montana
- How many people
- 210 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to Sep 2007
- Phase
- Phase 1
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy women during delivery
Who cannot join
- Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis
Trial locations and contacts
1 site in 1 country.
Menachem Oberbaum, MD contact
Israel1 site
Haddasah Medical Organization
Jerusalem
David Mankuta, MD
David Mankuta, MD
About this study
Official title: Phase 2 Study of the Effect of Bellis Perenis and Arnica Montana on Post Partum Hemmorhage
To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana
Read the detailed description
To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana compare it with placebo
- Conditions
- Hemorrhage
- Being tested
- Bellis Perenis ,Arnica montana
- Keywords
- post partum hemmorhage,Arnica montana,Bellis Perenis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bellis Perenis ,Arnica montanaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin levels 2 days post partum
Secondary outcomes (1)
pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startApr 2007
- Study completionSep 2007 (estimated)
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 HemorrhageStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Investigators
- David Mankuta, Study chair, Hadassah University Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405626
- Sponsor's protocol ID
- Hompostpartum-HMO-CTIL
- Status last verified
- Feb 2006
- First submitted
- 29 Nov 2006
- Last updated
- 30 Nov 2006
- Results posted
- No
Publications
Oberbaum M, Galoyan N, Lerner-Geva L, Singer SR, Grisaru S, Shashar D, Samueloff A. The effect of the homeopathic remedies Arnica montana and Bellis perennis on mild postpartum bleeding--a randomized, double-blind, placebo-controlled study--preliminary results. Complement Ther Med. 2005 Jun;13(2):87-90. doi: 10.1016/j.ctim.2005.03.006.
PubMed 16036165
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Effect of Bellis Perenis and Arnica Montana on Post Partum Hemmorhage
- ClinicalTrials.gov ID
- NCT00405626
- Acronym / sponsor ID
- Hompostpartum-HMO-CTIL
- Conditions
- Hemorrhage
- Keywords
- post partum hemmorhage,Arnica montana,Bellis Perenis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Study start
- Apr 2007
- Study completion
- Sep 2007 (estimated)
- First posted
- 30 Nov 2006 (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 look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana
Detailed description
To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana compare it with placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy women during delivery
Key exclusion criteria (1 listed)
- Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis
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 |
|---|---|---|
| Bellis Perenis ,Arnica montana | Drug | – |
Primary outcome
hemoglobin levels 2 days post partum
1 secondary outcome
pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2006.
- Results publication: PubMed 16036165Oberbaum M, Galoyan N, Lerner-Geva L, Singer SR, Grisaru S, Shashar D, Samueloff A. The effect of the homeopathic remedies Arnica montana and Bellis perennis on mild postpartum bleeding--a randomized, double-blind, placebo-controlled study--preliminary results. Complement Ther Med. 2005 Jun;13(2):87-90. doi: 10.1016/j.ctim.2005.03.006.
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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.
Menachem Oberbaum, MD contact
David Mankuta study chair
Hadassah University Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bellis Perenis ,Arnica montana in people with Hemorrhage, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 2006. 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 Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Mankuta, MD (5791070, mankuta@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin levels 2 days post partum. 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 NCT00405626, 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 30 Nov 2006.