NCT00198952

Brief Summary

to test safety and efficacy on metabolism, heart rate, blood pressure, TSH (and other blood)and hunger/caloric compensation on ephedra versus placebo

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2000

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

April 1, 2002

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

ObesityMetabolism

Outcome Measures

Primary Outcomes (5)

  • metabolic rate

  • heart rate

  • blood pressure

  • TSH

  • caloric compensation

Secondary Outcomes (2)

  • weight

  • body composition

Interventions

DietProDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-50, non-smoking, not pregnant (serum), Beck \<15, physician permission

You may not qualify if:

  • pregnant, lactating, smoker, use of appetite-affecting medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lawrence J Cheskin, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

February 1, 2000

Study Completion

March 1, 2001

Last Updated

September 20, 2005

Record last verified: 2002-04

Locations

US(1)