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NCT00719563 · OUTCOME

Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3

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 8

What was measured

Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).

Analysis population: Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.

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
Ginseng34
Placebo35

Reported measurements

MFSI-SF General
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng35.724.7Not reportedNot reportedNot reported
Placebo30.622.5Not reportedNot reportedNot reported
MFSI-SF Physical
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng7.617.5Not reportedNot reportedNot reported
Placebo3.820.8Not reportedNot reportedNot reported
MFSI-SF Mental
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng5.319.0Not reportedNot reportedNot reported
Placebo5.316.1Not reportedNot reportedNot reported
MFSI-SF Emotional
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng9.814.8Not reportedNot reportedNot reported
Placebo9.815.9Not reportedNot reportedNot reported
MFSI-SF Vigor
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng18.018.5Not reportedNot reportedNot reported
Placebo12.613.2Not reportedNot reportedNot reported
BFI Total Interference
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng30.623.5Not reportedNot reportedNot reported
Placebo20.920.5Not reportedNot reportedNot reported
LASA Fatigue
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng41.819.5Not reportedNot reportedNot reported
Placebo38.118.3Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.7
        value
        35.7
      2. group Id
        OG001
        spread
        22.5
        value
        30.6
    title
    MFSI-SF General
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.5
        value
        7.6
      2. group Id
        OG001
        spread
        20.8
        value
        3.8
    title
    MFSI-SF Physical
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.0
        value
        5.3
      2. group Id
        OG001
        spread
        16.1
        value
        5.3
    title
    MFSI-SF Mental
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.8
        value
        9.8
      2. group Id
        OG001
        spread
        15.9
        value
        9.8
    title
    MFSI-SF Emotional
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.5
        value
        18.0
      2. group Id
        OG001
        spread
        13.2
        value
        12.6
    title
    MFSI-SF Vigor
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.5
        value
        30.6
      2. group Id
        OG001
        spread
        20.5
        value
        20.9
    title
    BFI Total Interference
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.5
        value
        41.8
      2. group Id
        OG001
        spread
        18.3
        value
        38.1
    title
    LASA Fatigue
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      35
    units
    Participants
description
Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).
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 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.
reporting Status
POSTED
time Frame
Baseline and Week 8
title
Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice