Effect of Ginseng in Type 2 Diabetes

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02923453

Enrollment

Registered

2016-10-04

Start date

1998-03-31

Completion date

2002-08-31

Last updated

2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes Control

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.

Interventions

DIETARY_SUPPLEMENTCNT 2000 American ginseng extract

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1c	8 weeks

Secondary

Measure	Time frame
Fasting blood insulin	8 weeks
Blood pressure	8 weeks
serum nitrates/nitrites (NOx)	8 weeks
Fasting blood glucose	8 weeks
Alanine amino-transferase (ALT)	8 weeks
serum creatinine	8 weeks
Plasminogen activator inhibitor-1 (PAI-1)	8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026