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Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

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ClinicalTrials.gov Identifier: NCT00605202
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : December 9, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
University of Oulu

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypokalemia
Interventions: Drug: Hydrochlorothiazide
Dietary Supplement: Licorice

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Licorice First, Then Licorice and HCTZ Licorice 32 grams a day in the first intervention period, then licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the second intervention period.
Licorice and HCTZ First, Then Licorice Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the first intervention period, then licorice 32 grams a day in the second intervention period.

Participant Flow for 3 periods

Period 1:   First Intervention
    Licorice First, Then Licorice and HCTZ   Licorice and HCTZ First, Then Licorice
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 

Period 2:   Washout Period of 3 Weeks
    Licorice First, Then Licorice and HCTZ   Licorice and HCTZ First, Then Licorice
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Licorice First, Then Licorice and HCTZ   Licorice and HCTZ First, Then Licorice
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population No text entered.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   5 
Male   5 
Region of Enrollment 
[Units: Participants]
 
Finland   10 


  Outcome Measures

1.  Primary:   Plasma Potassium   [ Time Frame: Baseline and 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Janne Hukkanen
Organization: Oulu University Hospital, Department of Internal Medicine
phone: +358-8-315 6212
e-mail: janne.hukkanen@oulu.fi


Publications of Results:

Responsible Party: Professor Markku Savolainen, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT00605202     History of Changes
Other Study ID Numbers: Lakritsi ja hypokalemia
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: August 13, 2009
Results First Posted: December 9, 2009
Last Update Posted: December 15, 2009