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

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ClinicalTrials.gov Identifier: NCT01500096
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : June 12, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The purpose of this study is to determine whether American ginseng is effective in the treatment of HIV-associated fatigue.

Condition or disease Intervention/treatment Phase
HIV/AIDS-associated Fatigue Drug: American ginseng Dietary Supplement: Placebo for American ginseng Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Multiple-Dose Escalation Clinical Trial
Study Start Date : February 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue HIV/AIDS
Drug Information available for: Ginseng

Arm Intervention/treatment
Active Comparator: American ginseng 1000 mg/day
4-week of American ginseng 1000 mg/day every morning
Drug: 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.
Other Name: Panax quinquefolius

Placebo Comparator: Placebo for American ginseng 1000 mg/day
4-week of placebo for American ginseng 1000 mg/day every morning
Dietary Supplement: 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


Active Comparator: American ginseng 3000 mg/day
4-week of American ginseng 3000 mg/day every morning
Drug: 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.
Other Name: Panax quinquefolius

Placebo Comparator: Placebo for American ginseng 3000 mg/day
4-week of placebo for American ginseng 3000 mg/day every morning
Dietary Supplement: 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





Primary Outcome Measures :
  1. Change in Fatigue Severity Score (FSS) [ Time Frame: 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 Outcome Measures :
  1. Change in the Brief Fatigue Inventory [ Time Frame: 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.

  2. Change in Epworth Sleepiness Scale [ Time Frame: 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.

  3. Change in Patient Health Questionnaire 9 [ Time Frame: 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.

  4. Change in Insomnia Severity Index [ Time Frame: 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.

  5. Change in Medical Outcomes Study HIV Health Survey [ Time Frame: 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.

  6. Changes in Clinical Global Impressions [ Time Frame: 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".

  7. Inflammatory Markers [ Time Frame: 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.

  8. Change in CD4 Cell Count [ Time Frame: 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.

  9. Change in Plasma HIV RNA [ Time Frame: 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.

  10. Change in PROMIS Fatigue [ Time Frame: From baseline to week 4 (28 days of study drugs). ]
    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.

  11. Number of Participants With Adverse Events in the Ginseng and Placebo Arms [ Time Frame: From baseline to week 4 (28 days of study drugs) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. HIV-infected men and women, ≥18 years of age
  2. HIV-1 infection documented by a rapid HIV test or any licensed ELISA test kit and confirmed by a repeat ELISA, Western blot at any time prior to study entry; or documentation of ongoing HIV/AIDS care, or treatment for AIDS, or previous positive HIV serology at any time prior to study entry
  3. On stable antiretroviral therapy for at least three months
  4. Undetectable plasma HIV RNA using conventional assays with lower limits of quantification (20-75 copies/ml) obtained within 30 days prior to entry
  5. The following laboratory values obtained within 30 prior to study entry:

    Absolute neutrophil count (ANC) ≥750/mm3 Hematocrit ≥30 Platelet count ≥40,000/mm3 Calculated creatinine clearance (CrCl) ≥50 mL/min, as estimated by the Cockcroft-Gault equation* aspartate amino transferase (AST) serum glutamic oxalacetic transaminase (SGOT), amino alanine transferase (ALT) serum glutamic-pyruvic transaminase (SGPT), and alkaline phosphatase <3 x upper limit of normal (ULN) total bilirubin ≤2.5 x ULN

    NOTE: If the potential subject is taking an atazanavir-containing regimen at the time of screening, total bilirubin ≤5 x ULN is acceptable

    * Calculation for the Cockcroft-Gault equation is available at https://www.fstrf.org/common/utilities/calculators/ccc.html

  6. Clinically significant fatigue (≥4.5 on the FSS)
  7. PHQ-9 Questionnaire score <10
  8. ISI Questionnaire <14
  9. On stable psychiatric medications for at least 8 weeks prior to enrollment.
  10. Ability and willingness of subject to provide a signed informed consent and comply with all study requirements
  11. Laboratory values and physical examination as judged by the principal investigator to be safe to participate
  12. Females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy or tubal ligation) will need a negative serum or urine pregnancy test within 30 days prior to entry.

    NOTE: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and menopause is self-reported history.

  13. All potential subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/ partner must reliable methods of contraception (condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an intrauterine contraceptive device (IUD); or hormone-based contraceptive) while receiving study treatment. Subjects will be encourage to use a barrier method of contraception (e.g. condoms) along with hormonal contraceptives during administration of American ginseng.

EXCLUSION CRITERIA

  1. Untreated hypothyroidism (TSH >4.5 milli-international units per liter (mIU/L))
  2. Untreated or undertreated hypogonadism (calculated free testosterone below The lower limit of normal)
  3. Untreated or under-treated major depressive disorder
  4. No change in testosterone therapy within 6 weeks prior to screening
  5. As determined by the investigator, history of chronic or acute medical condition that in the opinion of the investigator would jeopardize safety of subjects participating in this study
  6. Hospitalization or therapy for serious illness within 30 days prior to study entry as judged by the investigator
  7. Known allergy/sensitivity or any hypersensitivity to components of American ginseng
  8. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence or subject compliance with study requirements (stable methadone treatment allowed)
  9. Current use or requirement for any medications prohibited with study treatment including warfarin. (Lists of prohibited medications are contained in the Prohibited Medications Section of the protocol)
  10. Pregnancy or breastfeeding
  11. Use of any immunomodulator (e.g., interferons, interleukins, systemic corticosteroids, cyclosporine), vaccine, or investigational therapy within 30 days prior to study entry
  12. Treatment with investigational study drugs/vaccines
  13. Co-enrolment in observational trials is allowed if the blood volume requirement does not exceed the Red Cross limits specified for this clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500096


Locations
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Center for Complementary and Integrative Health (NCCIH)