Trial record 17 of 17 for:    Open Studies | homeopathy

Efficacy of Arnica D1 Ointment After Upper Blepharoplasty (ARINE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Isala Klinieken
Sponsor:
Information provided by (Responsible Party):
Wynand BWH Melenhorst, MD, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT01598909
First received: May 12, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.


Condition Intervention
Blepharoplasty
Upper Eyelid Blepharoplasty
Drug: Arnica
Drug: Placebo ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • Surgical outcome [ Time Frame: 7 days and 6 weeks postoperatively ] [ Designated as safety issue: No ]
    Overall judgment of surgical outcome, based on the combined analysis of the amount of ecchymosis, swelling and redness, by an unrelated, uninvolved and "blinded" plastic surgeon.


Secondary Outcome Measures:
  • amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction [ Time Frame: 3, 7 and 42 days postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 136
Study Start Date: November 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arnica ointment Drug: Arnica
Application of Arnica ointment periorbitally
Placebo Comparator: Placebo ointment Drug: Placebo ointment
Application of Arnica ointment, twice a day, for the period of one week.
No Intervention: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing primary blepharoplasty

Exclusion Criteria:

  • use of anticoagulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598909

Contacts
Contact: W Melenhorst, MD PhD 0031384247380 w.b.w.h.melenhorst@isala.nl

Locations
Netherlands
Isala Klinieken Not yet recruiting
Zwolle, Netherlands, 8000 GK
Contact: W Melenhorst, MD PhD    0031384247380    w.b.w.h.melenhorst@isala.nl   
Sponsors and Collaborators
Wynand BWH Melenhorst, MD
Investigators
Principal Investigator: W Melenhorst, MD PhD Isala Klinieken Zwolle
  More Information

No publications provided

Responsible Party: Wynand BWH Melenhorst, MD, MD, PhD, Isala Klinieken
ClinicalTrials.gov Identifier: NCT01598909     History of Changes
Other Study ID Numbers: ARINE Study
Study First Received: May 12, 2012
Last Updated: October 31, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:
blepharoplasty
arnica
homeopathy

ClinicalTrials.gov processed this record on September 14, 2014