Back to resultsDouble Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH
Primary Purpose
Hemorrhage
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Bellis Perenis ,Arnica montana
Sponsored by
About this trial
This is an interventional prevention trial for Hemorrhage focused on measuring post partum hemmorhage,Arnica montana,Bellis Perenis
Eligibility Criteria
Inclusion Criteria:
- healthy women during delivery
Exclusion Criteria:
- Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis
Sites / Locations
- Haddasah Medical Organization
Outcomes
Primary Outcome Measures
hemoglobin levels 2 days post partum
Secondary Outcome Measures
pain
Full Information
NCT ID
NCT00405626
First Posted
November 29, 2006
Last Updated
November 29, 2006
Sponsor
Hadassah Medical Organization
Collaborators
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00405626
Brief Title
Double Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH
Official Title
Phase 2 Study of the Effect of Bellis Perenis and Arnica Montana on Post Partum Hemmorhage
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Shaare Zedek Medical Center
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
post partum hemmorhage,Arnica montana,Bellis Perenis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bellis Perenis ,Arnica montana
Primary Outcome Measure Information:
Title
hemoglobin levels 2 days post partum
Secondary Outcome Measure Information:
Title
pain
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy women during delivery
Exclusion Criteria:
Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Mankuta, MD
Phone
5791070
Email
mankuta@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Menachem Oberbaum, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mankuta
Organizational Affiliation
Hadassah University Medical Organization
Official's Role
Study Chair
Facility Information:
Facility Name
Haddasah Medical Organization
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Mankuta, MD
First Name & Middle Initial & Last Name & Degree
David Mankuta, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16036165
Citation
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.
Results Reference
result
Learn more about this trial
Double Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH
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