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NCT00719563 · OUTCOME

Change From Baseline to Week 4 in the General Subscale of the MFSI-SF

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

Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. 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
Ginseng147
Placebo153

Reported measurements

Source class 1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ginseng14.427.1Not reportedNot reportedNot reported
Placebo8.224.8Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0737
    statistical Method
    Wilcoxon Rank Sum
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0737
    statistical Method
    Wilcoxon Rank Sum
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.1
        value
        14.4
      2. group Id
        OG001
        spread
        24.8
        value
        8.2
denoms
  1. counts
    1. group Id
      OG000
      value
      147
    2. group Id
      OG001
      value
      153
    units
    Participants
description
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. 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 in the General Subscale of the MFSI-SF
type
PRIMARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice