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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
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Licorice First, Then Licorice and HCTZ Licorice and HCTZ First, Then Licorice
Hide Arm/Group Description 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 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.
Period Title: First Intervention
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Washout Period of 3 Weeks
Started 5 5
Completed 5 5
Not Completed 0 0
Period Title: Second Intervention
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 10 participants
10
1.Primary Outcome
Title Plasma Potassium
Hide Description Plasma potassium measured with indirect ion specific electrode method
Time Frame Baseline and 2 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Licorice Licorice and HCTZ
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mmol/l
Baseline 4.0  (0.2) 4.0  (0.3)
2 weeks 4.1  (0.3) 3.7  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Licorice, Licorice and HCTZ
Comments Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between arms
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments P-value of the change in the plasma potassium (baseline to 2 weeks) between arms
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Licorice Licorice and HCTZ
Hide Arm/Group Description Licorice 32 grams a day Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily
All-Cause Mortality
Licorice Licorice and HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Licorice Licorice and HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Licorice Licorice and HCTZ
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
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
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