NCT00504010

Brief Summary

Arnica in a topical gel formulation will be compared to a placebo to determine whether it decreases muscle soreness following leg exercise when applied to the legs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 7, 2009

Status Verified

January 1, 2009

Enrollment Period

1.1 years

First QC Date

July 17, 2007

Last Update Submit

January 6, 2009

Conditions

MusclesExerciseArnica

Keywords

arnicamuscle sorenessexerciseeccentric

Outcome Measures

Primary Outcomes (1)

  • Muscle soreness

    24 - 72 hours

Secondary Outcomes (2)

  • Muscle tenderness

    48 hours

  • Range of motion of ankle joint

    48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

arnica containing cream

Drug: Arnica Montana

2

PLACEBO COMPARATOR

carrier cream without arnica

Drug: placebo cream

Interventions

Arnica MontanaDRUG

Applied to lower extremity once a day for 3 days

1
placebo creamDRUG

placebo cream applied to leg daily for 3 days

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older
  • two fully functional legs

You may not qualify if:

  • allergy or sensitivity to the ester family
  • open wound or inflammatory condition on legs
  • chronic or acute leg pain
  • neuropathy involving one or both legs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Family Medicine

Houston, Texas, 77074, United States

Location

MeSH Terms

Conditions

Motor ActivityMyalgia

Interventions

Arnicae flos extract

Condition Hierarchy (Ancestors)

BehaviorMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David W Bauer, MD

    Memorial Hermann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 19, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 7, 2009

Record last verified: 2009-01

Locations

US(1)