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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00391339
Other study ID # CI-C-64-Wel-06
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received October 19, 2006
Last updated October 19, 2006
Start date November 2006
Est. completion date October 2008

Study information

Verified date October 2006
Source Weleda AG
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs. nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm labour.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date October 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Female

Exclusion Criteria:

- Bishop Score > 5

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bryophyllum p.


Locations

Country Name City State
Switzerland Department of Obstetrics, University of Zuerich Zuerich

Sponsors (1)

Lead Sponsor Collaborator
Weleda AG

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Gwehenberger B, Rist L, Huch R, von Mandach U. Effect of Bryophyllum pinnatum versus fenoterol on uterine contractility. Eur J Obstet Gynecol Reprod Biol. 2004 Apr 15;113(2):164-71. — View Citation

Plangger N, Rist L, Zimmermann R, von Mandach U. Intravenous tocolysis with Bryophyllum pinnatum is better tolerated than beta-agonist application. Eur J Obstet Gynecol Reprod Biol. 2006 Feb 1;124(2):168-72. Epub 2005 Jul 26. — View Citation

Vilàghy I. [Decreasing the rate of premature delivery with phytotherapy--results from general practice]. Ther Umsch. 2002 Dec;59(12):696-701. German. — View Citation