Trial · NCT01500096

American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial

NCT01500096, Phase 2, Completed, Johns Hopkins University; results first posted 2018-06-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial. Trials, record NCT01500096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01500096

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial
NCT number: NCT01500096
Status: Completed
Phases: Phase 2
Enrollment: 96 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: HIV/AIDS-associated Fatigue
Interventions: American ginseng, Placebo for American ginseng
First posted: 2011-12-26
Last updated: 2018-07-10
Results first posted: 2018-06-12

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Fatigue Severity Score (FSS)	From baseline to week 4 (28 days of study drugs)	Change in FSS score from baseline to Week 4. The change in fatigue as measured by the FSS (Week 4 minus Baseline) using the Wilcoxon test. The FSS is a scale score ranging from 1 to 63 with higher scores indicative of more fatigue. A negative number indicates a decline in the FSS scale. Participants with FSS data at both times points were assessed.
Secondary	Change in the Brief Fatigue Inventory	Change in BFI scores from baseline to week 4 (28 days of study drugs)	Questionnaire: Change in the Brief Fatigue Inventory (BFI) from baseline to week 4. We compared BFI scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. We used the BFI Question that assess "Worst Fatigue" score: 0 to 90 scale. Higher scores means more fatigue; negative values mean less fatigue.The BFI was used to supplement the data obtained from the FSS.
Secondary	Change in Epworth Sleepiness Scale	From baseline to week 4 (28 days of study drugs)	Questionnaire: Change in Epworth Sleepiness Scale (ESS) score from baseline to week 4. The ESS is scale ranges from 0 to 24; higher scores mean worse sleep disorder while a negative score indicates less sleep disorder. The ESS was used to supplement the data obtained from the FSS.
Secondary	Change in Patient Health Questionnaire 9	From baseline to week 4 (28 days of study drugs)	Questionnaire: Change in Patient Health Questionnaire 9 (PHQ9) score from baseline to week 4. The scale for the PHQ9 score ranges from 0 to 27; higher scores mean worse depression; negative scores indicate less depression. We compared PHQ 9 scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. The PHQ9 was used to supplement the data obtained from the FSS.
Secondary	Change in Insomnia Severity Index	From baseline to week 4 (28 days of study drugs)	Questionnaire: Change in Insomnia Severity Index (ISI) score from baseline to week 4. The ISI scale ranges from 0 to 28; higher scores mean worse insomnia while negative scores indicate less insomnia. The ISI was used to supplement the data obtained from the FSS.
Secondary	Change in Medical Outcomes Study HIV Health Survey	From baseline to week 4 (28 days of study drugs)	Questionnaire: Change in Medical Outcomes Study (MOS) HIV Health Survey score from baseline to week 4. We evaluated the MOS Energy Fatigue scores; the MOS scale ranges from 0-100; higher scores mean more energy. The MOS was used to supplement the data obtained from the FSS.
Secondary	Changes in Clinical Global Impressions	From baseline to week 4 (28 days of study drugs)	Questionnaire: Change in Clinical Global Impressions (CGI) scores from baseline to week 4. CGI is an instrument for making global assessments of worsening or improvement during interventional trials. The subject rates the change in the overall status since beginning the intervention (ranging from: very much improved, much improved, minimally improved, no change, and minimally worse). We assessed the number of participants who rated "very much improved".
Secondary	Inflammatory Markers	From baseline to week 4 (28 days of study drugs)	Laboratory - Inflammatory Markers (IMs): Change in Interleukin (IL) -6 and soluble receptors of tumor necrosis factor (TNF) α 1 and 2 (sTNFR1 and sTNFR2) from baseline to week 4. Negative values indicate less change in inflammatory markers.
Secondary	Change in CD4 Cell Count	From baseline to week 5 (28 days of study drugs)	Laboratory: Change in absolute cluster of differentiation 4 (CD4) cell count from baseline to week 5. Negative values mean decline in CD4 cell count.
Secondary	Change in Plasma HIV RNA	From baseline to week 4 (28 days of study drugs)	Laboratory: Change in plasma HIV RNA from baseline to week 4. A negative value means a drop in plasma HIV RNA.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Fatigue Severity Score (FSS)	From baseline to week 4 (28 days of study drugs)	There was one missing scale from the ginseng 3000 arm	units on a scale	MEAN
SECONDARY	Change in the Brief Fatigue Inventory	Change in BFI scores from baseline to week 4 (28 days of study drugs)	There was on missing questionnaire from the ginseng 3000 arm	units on a scale	MEAN
SECONDARY	Change in Epworth Sleepiness Scale	From baseline to week 4 (28 days of study drugs)	There was one missing questionnaire from the ginseng 3000 arm	units on a scale	MEAN
SECONDARY	Change in Patient Health Questionnaire 9	From baseline to week 4 (28 days of study drugs)	There was one missed PHQ9 in the ginseng 3000 mg arm	units on a scale	MEAN
SECONDARY	Change in Insomnia Severity Index	From baseline to week 4 (28 days of study drugs)	There was one missing ISI in the ginseng 3000 mg arm	units on a scale	MEAN
SECONDARY	Change in Medical Outcomes Study HIV Health Survey	From baseline to week 4 (28 days of study drugs)		units on a scale	MEAN
SECONDARY	Changes in Clinical Global Impressions	From baseline to week 4 (28 days of study drugs)		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Inflammatory Markers	From baseline to week 4 (28 days of study drugs)		pg/ml	MEAN
SECONDARY	Change in CD4 Cell Count	From baseline to week 5 (28 days of study drugs)		cells per cubic millimeter	MEAN
SECONDARY	Change in Plasma HIV RNA	From baseline to week 4 (28 days of study drugs)		copies/mL	MEAN

1 to 10 of 12Source ClinicalTrials.gov

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Results by group56

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Fatigue Severity Score (FSS)	American Ginseng 1000 mg/Day	-24.7	Standard Deviation 18.6	units on a scale
Change in Fatigue Severity Score (FSS)	Placebo for American Ginseng 1000 mg/Day	-16.3	Standard Deviation 18.6	units on a scale
Change in Fatigue Severity Score (FSS)	American Ginseng 3000 mg/Day	-16.9	Standard Deviation 15	units on a scale
Change in Fatigue Severity Score (FSS)	Placebo for American Ginseng 3000 mg/Day	-21.6	Standard Deviation 16.0	units on a scale
Change in the Brief Fatigue Inventory	American Ginseng 1000 mg/Day	-44.2	Standard Deviation 34.3	units on a scale
Change in the Brief Fatigue Inventory	Placebo for American Ginseng 1000 mg/Day	-26.5	Standard Deviation 28.5	units on a scale
Change in the Brief Fatigue Inventory	American Ginseng 3000 mg/Day	-42.7	Standard Deviation 32.4	units on a scale
Change in the Brief Fatigue Inventory	Placebo for American Ginseng 3000 mg/Day	-37.9	Standard Deviation 35.1	units on a scale
Change in Epworth Sleepiness Scale	American Ginseng 1000 mg/Day	-5.74	Standard Error 7.15	units on a scale
Change in Epworth Sleepiness Scale	Placebo for American Ginseng 1000 mg/Day	-6.35	Standard Error 4.43	units on a scale

1 to 10 of 56Source ClinicalTrials.gov

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Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	American Ginseng 1000 mg/Day	32
Overall Study	STARTED	Placebo for American Ginseng 1000 mg/Day	17
Overall Study	STARTED	American Ginseng 3000 mg/Day	31
Overall Study	STARTED	Placebo for American Ginseng 3000 mg/Day	16
Overall Study	COMPLETED	American Ginseng 1000 mg/Day	31
Overall Study	COMPLETED	Placebo for American Ginseng 1000 mg/Day	17
Overall Study	COMPLETED	American Ginseng 3000 mg/Day	31
Overall Study	COMPLETED	Placebo for American Ginseng 3000 mg/Day	14
Overall Study	NOT COMPLETED	American Ginseng 1000 mg/Day	1
Overall Study	NOT COMPLETED	Placebo for American Ginseng 1000 mg/Day	0

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	anxiety	Psychiatric disorders	American Ginseng 1000 mg/Day	11	32	11
other	anxiety	Psychiatric disorders	Placebo for American Ginseng 1000 mg/Day	9	17	9
other	anxiety	Psychiatric disorders	American Ginseng 3000 mg/Day	7	31	7
other	anxiety	Psychiatric disorders	Placebo for American Ginseng 3000 mg/Day	5	16	5
other	cough	Respiratory, thoracic and mediastinal disorders	American Ginseng 1000 mg/Day	3	32	3
other	cough	Respiratory, thoracic and mediastinal disorders	Placebo for American Ginseng 1000 mg/Day	1	17	1
other	cough	Respiratory, thoracic and mediastinal disorders	American Ginseng 3000 mg/Day	0	31	0
other	cough	Respiratory, thoracic and mediastinal disorders	Placebo for American Ginseng 3000 mg/Day	1	16	1
other	Decreased ANC	Blood and lymphatic system disorders	American Ginseng 1000 mg/Day	5	32	5
other	Decreased ANC	Blood and lymphatic system disorders	Placebo for American Ginseng 1000 mg/Day	3	17	3

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	American Ginseng 1000 mg/Day	0	32
Total, all-cause mortality	Placebo for American Ginseng 1000 mg/Day	0	17
Total, all-cause mortality	American Ginseng 3000 mg/Day	0	31
Total, all-cause mortality	Placebo for American Ginseng 3000 mg/Day	0	16
Total, other adverse events	American Ginseng 1000 mg/Day	30	32
Total, other adverse events	Placebo for American Ginseng 1000 mg/Day	16	17
Total, other adverse events	American Ginseng 3000 mg/Day	31	31
Total, other adverse events	Placebo for American Ginseng 3000 mg/Day	13	16
Total, serious adverse events	American Ginseng 1000 mg/Day	2	32
Total, serious adverse events	Placebo for American Ginseng 1000 mg/Day	2	17

1 to 10 of 12Source ClinicalTrials.gov

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Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18713456	BACKGROUND	PubMed
19415341	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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