Double Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH

November 29, 2006 updated by: Hadassah Medical Organization

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

Study Overview

Status

Unknown

Conditions

Hemorrhage

Intervention / Treatment

Drug: Bellis Perenis ,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 Type

Interventional

Enrollment (Anticipated)

210

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Jerusalem, Israel
    - Haddasah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

healthy women during delivery

Exclusion Criteria:

Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
hemoglobin levels 2 days post partum

Secondary Outcome Measures

Outcome Measure
pain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Shaare Zedek Medical Center

Investigators

Study Chair: David Mankuta, Hadassah University Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Anticipated)

September 1, 2007

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Estimate)

November 30, 2006

Last Update Submitted That Met QC Criteria

November 29, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

post partum hemmorhage,Arnica montana,Bellis Perenis

Additional Relevant MeSH Terms

Other Study ID Numbers

Hompostpartum-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.