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Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Information source: University of Oulu
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypokalemia

Intervention: Hydrochlorothiazide (Drug); Licorice (Dietary Supplement)

Phase: Phase 4

Status: Completed

Sponsored by: University of Oulu

Official(s) and/or principal investigator(s):
Markku Savolainen, MD, Principal Investigator, Affiliation: Oulu University Hospital

Summary

This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day for 14 days given in the other arm. The study is a randomized, open-label cross-over trial. There is at least a 3-week wash-out between the arms. The hypothesis is that the combination of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the change in the plasma level of potassium between the arms.

Clinical Details

Official title: Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma Potassium

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy volunteer

- Age 18-40 years

Exclusion Criteria:

- Any continuous medication

- Any significant disease

- Hypotension or hypertension

- Allergy to licorice or hydrochlorothiazide

- Pregnancy and breast feeding

- Fear of needles and previous difficult blood samplings

- Substance abuse

- Participation in another clinical drug trial within 1 month of enrollment

Locations and Contacts

Oulu University Hospital, Oulu 90220, Finland
Additional Information

Starting date: February 2008
Last updated: December 10, 2009

Page last updated: August 23, 2015

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