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NCT00719563 · OUTCOME

Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue

American Ginseng in Treating Patients With Fatigue Caused by Cancer · Source last updated 2017-02-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline and Week 4

What was measured

Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Analysis population: Includes all participants who completed both baseline and week 4 assessments.

Groups in this outcome

Ginseng

Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.

Placebo

Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ginseng150
Placebo150

Reported measurements

Fatigue Usual
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng11.925.7Not reportedNot reportedNot reported
Placebo9.923.4Not reportedNot reportedNot reported
Fatigue Now
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng11.826.4Not reportedNot reportedNot reported
Placebo7.924.1Not reportedNot reportedNot reported
Fatigue Worst
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng11.825.6Not reportedNot reportedNot reported
Placebo9.725.3Not reportedNot reportedNot reported
BFT Total Interference
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng9.222.0Not reportedNot reportedNot reported
Placebo5.821.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.7
        value
        11.9
      2. group Id
        OG001
        spread
        23.4
        value
        9.9
    title
    Fatigue Usual
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.4
        value
        11.8
      2. group Id
        OG001
        spread
        24.1
        value
        7.9
    title
    Fatigue Now
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.6
        value
        11.8
      2. group Id
        OG001
        spread
        25.3
        value
        9.7
    title
    Fatigue Worst
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.0
        value
        9.2
      2. group Id
        OG001
        spread
        21.1
        value
        5.8
    title
    BFT Total Interference
denoms
  1. counts
    1. group Id
      OG000
      value
      150
    2. group Id
      OG001
      value
      150
    units
    Participants
description
Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
dispersion Type
Standard Deviation
groups
  1. description
    Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
    id
    OG000
    title
    Ginseng
  2. description
    Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Includes all participants who completed both baseline and week 4 assessments.
reporting Status
POSTED
time Frame
Baseline and Week 4
title
Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice