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Trial record 2 of 5 for:    15632335 [PUBMED-IDS]

Effect of Ginseng in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02923453
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover design, the participants are randomized to receive either placebo or American ginseng extract (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment. Following ≥4-week washout period the participants are crossed over to another 8-week treatment arm. Throughout the study period, all individuals maintain their original diabetes treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety parameters include liver, kidney and hemostatic functions.

Condition or disease Intervention/treatment Phase
Type II Diabetes Control Dietary Supplement: CNT 2000 American ginseng extract Dietary Supplement: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of American Ginseng (Penax Quinquefolius) Extract on Glycemic Control in Individuals With Type 2 Diabetes: A Double-blind, Randomized, Crossover Clinical Trial
Study Start Date : March 1998
Actual Primary Completion Date : December 2001
Actual Study Completion Date : August 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
1g/meal of placebo three times per day (3g/day) for 8-weeks.
Dietary Supplement: Placebo
Active Comparator: Ginseng Extract
CNT2000 (Chai-Na- Ta Corp., Langley, BC) American ginseng extract 1g/meal of placebo three times per day (3g/day) for 8-weeks.
Dietary Supplement: CNT 2000 American ginseng extract



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: 8 weeks ]
  2. Fasting blood insulin [ Time Frame: 8 weeks ]
  3. Blood pressure [ Time Frame: 8 weeks ]
  4. serum nitrates/nitrites (NOx) [ Time Frame: 8 weeks ]
  5. Plasminogen activator inhibitor-1 (PAI-1) [ Time Frame: 8 weeks ]
  6. Alanine amino-transferase (ALT) [ Time Frame: 8 weeks ]
  7. serum creatinine [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of type 2 diabetes of ≥1 year duration
  • BMI between 25-35kg/m^2
  • HbA1c between 6.5-8.5%

Exclusion Criteria:

  • Patients on insulin therapy
  • Impaired hepatic or renal function
  • Clinically manifested diabetic complications
  • Present cardiac problems
  • Uncontrolled hypoglycemia
  • Cigarette smokers
  • Alcohol consumption (>2 drinks per week)
  • Taking ginseng or other herb with possible hypoglycemic effect
  • Involvement in any other investigational drug studies
  • Changed medication during the course of the study periods or during the washout period

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): NCT02923453


Locations
Canada, Ontario
: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto

Publications:
Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02923453     History of Changes
Other Study ID Numbers: CNT 2000
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases