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Completed

NCT Number: NCT00605202

Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oulu University Hospital

Oulu, 90220, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrochlorothiazide

Drug

Hydrochlorothiazide 25 mg a day for 14 days.

Other names: Hydrex semi, ATC C03AA03

Licorice

Dietary Supplement

Licorice candy 32 grams a day for 14 days.

Other names: Pepe Original candy

Primary outcomes

  1. Plasma Potassium

    Time frame: Baseline and 2 weeks

    Plasma potassium measured with indirect ion specific electrode method

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 30, 2008
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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