American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00752895
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 293
• Locations: 125
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng extract is more effective than a placebo in preventing respiratory infections.

PURPOSE: This randomized trial is studying the side effects of American ginseng extract and to see how well it works compared with a placebo in preventing respiratory infection and in reducing antibiotic use in patients with chronic lymphocytic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Dietary Supplement: American ginseng; Dietary Supplement: Placebo	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To assess the effect of American ginseng extract on the number of days of acute respiratory infection (ARI) during the peak respiratory illness season (January-March) in patients with chronic lymphocytic leukemia (CLL).

• To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.

Secondary

• To assess the effect of this treatment on antibiotic use days (AUDs).

• To assess the effect of this treatment on the rate of all infections diagnosed by a physician.

• To assess the effect of this treatment on the duration and severity of each ARI episode.

• To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.

• To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.

• To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).

• To determine the incidence of ARI and type of illness in an untreated cohort of CLL patients over an entire winter respiratory illness season (January 1- April 30).

Tertiary

• To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician.

OUTLINE: This is a multicenter study. Patients are stratified according to antibiotic prophylaxis with trimethoprim-sulfamethoxazole (yes vs no), serum IgG (≤ 500 mg/dL vs > 500 mg/dL), and influenza vaccine status (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral American ginseng extract twice daily.

• Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for up to 4 months in the absence of illness or adverse events.

After completion of study treatment, patients are followed at 4 weeks by phone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 293 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Double-Blind, Placebo Controlled Trial of North American Ginseng Extract (CVT-E002; COLD-fX®) to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients With Chronic Lymphocytic Leukemia
• Actual Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I - Ginseng Patients receive oral American ginseng extract twice daily.	Dietary Supplement: American ginseng; Given orally
Placebo Comparator: Arm II - Placebo Patients receive oral placebo twice daily.	Dietary Supplement: Placebo; Given orally

Outcome Measures

Primary Outcome Measures

1. Acute Respiratory Infection (ARI) Days [3 months]

   An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.

Secondary Outcome Measures

1. Number of Antibiotic Use Days [3 months]

   An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of chronic lymphocytic leukemia (CLL)

• Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease

• Untreated CLL allowed

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

• Life expectancy > 12 months

• Creatinine < 2.0 mg/dL OR creatinine clearance > 50 mL/min

• AST/ALT ≤ 2.5 times upper limit of normal (ULN)

• Total bilirubin ≤ 1.5 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception prior to and during study treatment

• No known cirrhosis, collagen vascular disease, multiple sclerosis, or HIV positivity

• No other prior or concurrent malignancies except for non-melanoma skin cancers or carcinoma in situ of the cervix

• Other prior malignancies allowed provided the patient has been disease-free for > 5 years

• No uncontrolled intercurrent illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• No psychiatric or social illness that would limit compliance with study requirements

• No history of allergy or other adverse response to ginseng products

• No history of seasonal or environmental allergies that require ongoing treatment with antihistamines, intranasal corticosteroids, or systemic corticosteroids

PRIOR CONCURRENT THERAPY:

• More than 3 months since prior and no concurrent chlorambucil

• At least 1 month since prior and no other concurrent herbal ginseng products

• No prior or concurrent fludarabine, alemtuzumab, rituximab, intravenous immunoglobulin, or hematopoietic stem cell transplantation

• No concurrent corticosteroids (20 mg/day of prednisone or equivalent)

• No concurrent antibiotic prophylaxis, except for trimethoprim-sulfamethoxazole

• No concurrent warfarin

• No other concurrent investigational or commercial agents or other therapies with the intent to treat the patient's malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Saint Joseph Medical Center - Burbank	Burbank	California	United States	91505
2	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California	United States	92868
3	Helen and Harry Gray Cancer Center at Hartford Hospital	Hartford	Connecticut	United States	06102-5037
4	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
5	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
6	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
7	Graham Hospital	Canton	Illinois	United States	61520
8	Memorial Hospital	Carthage	Illinois	United States	62321
9	Eureka Community Hospital	Eureka	Illinois	United States	61530
10	Evanston Northwestern Healthcare - Evanston Hospital	Evanston	Illinois	United States	60201-1781
11	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
12	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
13	Mason District Hospital	Havana	Illinois	United States	62644
14	Hopedale Medical Complex	Hopedale	Illinois	United States	61747
15	McDonough District Hospital	Macomb	Illinois	United States	61455
16	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
17	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois	United States	61265
18	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
19	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
20	Community Cancer Center	Normal	Illinois	United States	61761
21	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
22	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
23	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
24	Proctor Hospital	Peoria	Illinois	United States	61614
25	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
26	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
27	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
28	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
29	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
30	Perry Memorial Hospital	Princeton	Illinois	United States	61356
31	St. Margaret's Hospital	Spring Valley	Illinois	United States	61362
32	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
33	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
34	St. Vincent Indianapolis Hospital	Indianapolis	Indiana	United States	46260
35	St. Vincent Oncology Center	Indianapolis	Indiana	United States	46260
36	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
37	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
38	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
39	Genesis Medical Center - West Campus	Davenport	Iowa	United States	52804
40	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
41	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
42	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
43	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
44	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
45	Southwest Medical Center	Liberal	Kansas	United States	67901
46	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
47	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
48	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
49	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67042
50	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
51	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
52	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
53	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
54	CCOP - Wichita	Wichita	Kansas	United States	67214
55	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
56	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
57	Pennington Cancer Center at Baton Rouge General	Baton Rouge	Louisiana	United States	70806
58	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
59	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
60	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
61	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
62	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
63	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
64	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
65	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
66	Haematology-Oncology Associates of Ohio and Michigan, PC	Lambertville	Michigan	United States	48144
67	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
68	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
69	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
70	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital	Cape Girardeau	Missouri	United States	63701
71	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
72	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri	United States	63109
73	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
74	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
75	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
76	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59101
77	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
78	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
79	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
80	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
81	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
82	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
83	Northern Montana Hospital	Havre	Montana	United States	59501
84	St. Peter's Hospital	Helena	Montana	United States	59601
85	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
86	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
87	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
88	Community Medical Center	Missoula	Montana	United States	59801
89	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
90	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
91	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
92	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
93	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
94	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
95	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire	United States	03833
96	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
97	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York	United States	11030
98	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11042
99	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
100	MeritCare Broadway	Fargo	North Dakota	United States	58122
101	Hematology Oncology Center	Elyria	Ohio	United States	44035
102	Lima Memorial Hospital	Lima	Ohio	United States	45804
103	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
104	St. Luke's Hospital	Maumee	Ohio	United States	43537
105	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
106	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
107	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
108	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
109	Toledo Hospital	Toledo	Ohio	United States	43606
110	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
111	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
112	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
113	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
114	Medical X-Ray Center, PC	Sioux Falls	South Dakota	United States	57105
115	Sanford Cancer Center at Sanford USD Medical Center	Sioux Falls	South Dakota	United States	57117-5039
116	Presbyterian Hospital of Dallas	Dallas	Texas	United States	75231
117	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
118	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
119	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
120	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
121	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
122	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
123	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
124	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
125	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Kevin High, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00752895
• Other Study ID Numbers: IRB00006819; U10CA081851; REBACCCWFU98308
• First Posted: Sep 16, 2008
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
• Additional relevant MeSH terms: Respiratory Tract Infections; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

Participant Flow

Arm/Group Title	Arm I - Ginseng	Arm II - Placebo
Arm/Group Description	Patients receive oral American ginseng extract twice daily. American ginseng: Given orally	Patients receive oral placebo twice daily. Placebo: Given orally
Period Title: Overall Study
STARTED	147	146
COMPLETED	139	143
NOT COMPLETED	8	3

Baseline Characteristics

Arm/Group Title	Arm I - Ginseng	Arm II - Placebo	Total
Arm/Group Description	Patients receive oral American ginseng extract twice daily. American ginseng: Given orally	Patients receive oral placebo twice daily. Placebo: Given orally	Total of all reporting groups
Overall Participants	147	146	293
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	71 48.3%	64 43.8%	135 46.1%
>=65 years	76 51.7%	82 56.2%	158 53.9%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	65	66	65
Sex: Female, Male (Count of Participants)
Female	65 44.2%	60 41.1%	125 42.7%
Male	82 55.8%	86 58.9%	168 57.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	2 1.4%	2 0.7%
Not Hispanic or Latino	147 100%	144 98.6%	291 99.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 0.7%	1 0.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 1.4%	3 2.1%	5 1.7%
White	145 98.6%	141 96.6%	286 97.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 0.7%	1 0.3%
Region of Enrollment (participants) [Number]
United States	147 100%	146 100%	293 100%

Outcome Measures

1. Primary Outcome

Title	Acute Respiratory Infection (ARI) Days
Description	An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.

Arm/Group Title	Arm I - Ginseng	Arm II - Placebo
Arm/Group Description	Patients receive oral American ginseng extract twice daily. American ginseng: Given orally	Patients receive oral placebo twice daily. Placebo: Given orally
Measure Participants	137	143
Mean (Standard Deviation) [days]	8.30 (16.87)	6.78 (13.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - Ginseng, Arm II - Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.295
	Comments	This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.
	Method	Negative binomial regression
	Comments

2. Secondary Outcome

Title	Number of Antibiotic Use Days
Description	An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.

Arm/Group Title	Arm I - Ginseng	Arm II - Placebo
Arm/Group Description	Patients receive oral American ginseng extract twice daily. American ginseng: Given orally	Patients receive oral placebo twice daily. Placebo: Given orally
Measure Participants	137	143
Mean (Standard Deviation) [days]	1.12 (3.42)	1.55 (6.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I - Ginseng, Arm II - Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.820
	Comments	This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.
	Method	Negative binomial regression
	Comments

Adverse Events

Time Frame	5 months
Adverse Event Reporting Description	Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
Arm/Group Title	Arm I - Ginseng		Arm II - Placebo
Arm/Group Description	Patients receive oral American ginseng extract twice daily. American ginseng: Given orally		Patients receive oral placebo twice daily. Placebo: Given orally
All Cause Mortality
	Arm I - Ginseng		Arm II - Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I - Ginseng		Arm II - Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/140 (7.9%)		16/143 (11.2%)
Blood and lymphatic system disorders
Hemolysis	0/140 (0%)	0	1/143 (0.7%)	1
Platelets (160-360)	0/140 (0%)	0	1/143 (0.7%)	3
Cardiac disorders
Cardiac ischemia/fnfarction	1/140 (0.7%)	1	2/143 (1.4%)	2
Hypertension	1/140 (0.7%)	2	0/143 (0%)	0
Hypotension	0/140 (0%)	0	1/143 (0.7%)	1
Supraventricular and nodal arrhythmia: Sinus Bradycardia	1/140 (0.7%)	1	0/143 (0%)	0
Syncope (fainting)	1/140 (0.7%)	1	0/143 (0%)	0
Ventricular Arrhythmia NOS	1/140 (0.7%)	1	0/143 (0%)	0
Ear and labyrinth disorders
Dizziness	1/140 (0.7%)	1	0/143 (0%)	0
Gastrointestinal disorders
Diarrhea	1/140 (0.7%)	1	0/143 (0%)	0
Diarrhea - without colostomy	1/140 (0.7%)	1	0/143 (0%)	0
Hemorrhage, GI: Peritoneal cavity	0/140 (0%)	0	1/143 (0.7%)	1
Vomiting	0/140 (0%)	0	1/143 (0.7%)	1
General disorders
Pain: Abdomen NOS	0/140 (0%)	0	3/143 (2.1%)	4
Pain: Back	0/140 (0%)	0	1/143 (0.7%)	1
Pain: Chest Wall	0/140 (0%)	0	2/143 (1.4%)	2
Pain: Chest/thorax NOS	0/140 (0%)	0	1/143 (0.7%)	1
Pain:Stomach	0/140 (0%)	0	1/143 (0.7%)	1
Infections and infestations
Infection with Grade 3/4 ANC: Skin	0/140 (0%)	0	1/143 (0.7%)	1
Infection with normal ANC or grade 1/2 neutrophils: Lung (pneumonia)	1/140 (0.7%)	1	0/143 (0%)	0
Infection with normal ANC or Grade 1/2 neutrophils: Spleen	0/140 (0%)	0	1/143 (0.7%)	2
Infection with unknown ANC: upper airway NOS	0/140 (0%)	0	1/143 (0.7%)	1
Infection with unknown ANC: Brain (encephalitis)	1/140 (0.7%)	1	0/143 (0%)	0
Metabolism and nutrition disorders
Hypercalcemia	1/140 (0.7%)	1	0/143 (0%)	0
Hyperglycemia	1/140 (0.7%)	1	2/143 (1.4%)	2
Musculoskeletal and connective tissue disorders
Pain - Joint	1/140 (0.7%)	3	3/143 (2.1%)	5
Nervous system disorders
Headache	0/140 (0%)	0	1/143 (0.7%)	1
Seizure	1/140 (0.7%)	1	0/143 (0%)	0
Renal and urinary disorders
Urinary Frequency / Urgency	1/140 (0.7%)	1	0/143 (0%)	0
Urinary Frequency / Urgency - Pllakiuria	1/140 (0.7%)	1	0/143 (0%)	0
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing	0/140 (0%)	0	1/143 (0.7%)	1
Dyspnea	2/140 (1.4%)	2	2/143 (1.4%)	2
Pleural Effusion (non-malignant)	0/140 (0%)	0	1/143 (0.7%)	1
Skin and subcutaneous tissue disorders
Rash/Desquamation	0/140 (0%)	0	1/143 (0.7%)	1
Ulceration	0/140 (0%)	0	1/143 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Arm I - Ginseng		Arm II - Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	121/140 (86.4%)		126/143 (88.1%)
Cardiac disorders
Hypertension	21/140 (15%)	34	23/143 (16.1%)	37
Gastrointestinal disorders
Diarrhea - without colostomy	15/140 (10.7%)	22	19/143 (13.3%)	25
Heartburn	27/140 (19.3%)	46	36/143 (25.2%)	57
Nausea	8/140 (5.7%)	9	14/143 (9.8%)	18
Vomiting	4/140 (2.9%)	4	8/143 (5.6%)	8
General disorders
Hemorrhage, Nose - Epistaxis	3/140 (2.1%)	4	11/143 (7.7%)	15
Metabolism and nutrition disorders
Hyperglycemia	32/140 (22.9%)	56	44/143 (30.8%)	70
Musculoskeletal and connective tissue disorders
Pain - Joint	57/140 (40.7%)	110	65/143 (45.5%)	123
Nervous system disorders
Dizziness	17/140 (12.1%)	27	18/143 (12.6%)	24
Headache	38/140 (27.1%)	58	39/143 (27.3%)	63
Neurology - Other - Nervousness	18/140 (12.9%)	22	11/143 (7.7%)	15
Psychiatric disorders
Insomnia	55/140 (39.3%)	85	36/143 (25.2%)	63
Renal and urinary disorders
Urinary Frequency / Urgency - Pllakiuria	40/140 (28.6%)	77	33/143 (23.1%)	54
Skin and subcutaneous tissue disorders
Rash / Desquamation	6/140 (4.3%)	6	13/143 (9.1%)	20

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.