4-week of American ginseng 1000 mg/day every morning

4-week of placebo for American ginseng 1000 mg/day every morning

4-week of American ginseng 3000 mg/day every morning

4-week of placebo for American ginseng 3000 mg/day every morning

4-week of American ginseng 1000 mg/day every morning
American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

American Ginseng 1000 mg/Day

4-week of placebo for American ginseng 1000 mg/day every morning
Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.
Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Placebo for American Ginseng 1000 mg/Day

4-week of American ginseng 3000 mg/day every morning
American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

American Ginseng 3000 mg/Day

4-week of placebo for American ginseng 3000 mg/day every morning
Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.
Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Placebo for American Ginseng 3000 mg/Day

Total

Sex: Female, Male

Region of Enrollment

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.

Change in Fatigue Severity Score (FSS)

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.

Change in the Brief Fatigue Inventory

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.

Change in Epworth Sleepiness Scale

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.

Change in Patient Health Questionnaire 9

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.

Change in Insomnia Severity Index

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.

Change in Medical Outcomes Study HIV Health Survey

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".

Changes in Clinical Global Impressions

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.

Inflammatory Markers

Laboratory: Change in absolute cluster of differentiation 4 (CD4) cell count from baseline to week 5. Negative values mean decline in CD4 cell count.

Change in CD4 Cell Count

Laboratory: Change in plasma HIV RNA from baseline to week 4. A negative value means a drop in plasma HIV RNA.

Change in Plasma HIV RNA

Questionnaire: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue score from baseline to week 4. Change in PROMIS fatigue score from baseline to Week 4. The change in fatigue as measured by the PROMIS fatigue (Week 4 minus Baseline) using the Wilcoxon test. The PROMIS fatigue is a scale with normalized mean of 50 and standard deviation (SD) of 10. Higher mean values mean more fatigue and negative values indicate less fatigue.

Change in PROMIS Fatigue

Adverse events (AEs) were assessed from baseline to wk 4 using the NIH Division of AIDS (DAIDS) Grading Toxicity Table, a well known tool used by NIH networks for assessing the severity of AEs in participants enrolled in clinical trials. Reporting the number of participants in each arm who experienced adverse events.

Number of Participants With Adverse Events in the Ginseng and Placebo Arms

Overall Study

Adriana Andrade

HIV/AIDS-associated Fatigue

American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

American ginseng

Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.
Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

panax/akuutti patologinen solukuolema

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

Täydellisin lääketieteellinen tietokanta tieteen tukemana