Viewing Study NCT04210895


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Study NCT ID: NCT04210895
Status: COMPLETED
Last Update Posted: 2020-04-14
First Post: 2019-12-18
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep
Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
Organization:

Study Overview

Official Title: Efficacy of Footbaths With Ginger Powder on Subjectively Perceived Quality of Sleep: a Randomized Controlled Pilot Study
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A randomized, controlled trial to explore whether warm footbaths with added ginger powder can improve the sleep quality of adults with self-perceived insomnia symptoms. Participants receive daily footbaths either with warm water alone or with added ginger powder over a period of 2 weeks.
Detailed Description: This is a randomized controlled trial with parallel group design to explore the effects of warm water footbaths with added ginger powder (experimental) compared to footbaths with warm water alone (active comparator) on sleep quality in adults with self-perceived insomnia symptoms. Participants receive daily footbaths 1-3 hours before bedtime over a period of two weeks. The footbaths are prepared by the participants themselves and carried out at their homes. Outcome measures are assessed at baseline (pre intervention) and two weeks after baseline (post intervention). The main focus is on change in subjective quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI). The statistical analysis comprises analyses of variance based on linear mixed effects models.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: