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Efficacy and safety of ginsam, a vinegar extract from Panax ginseng, in type 2 diabetic patients: Results of a double-blind, placebo-controlled study.

ABSTRACT:

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Aims/Introduction: The efficacy, dose-response relationship and safety of ginsam, a vinegar extract from Panax ginseng, were evaluated in an 8-week, double-blind, randomized, placebo-controlled study in drug-naïve patients with type 2 diabetes.

Materials and methods

A total of 72 diabetic patients were randomized to receive 1500, 2000 or 3000 mg of ginsam, or placebo daily for 8 weeks (n = 18 in each group). The primary end-point was the changes from the baseline HbA1c level. The secondary end-points were the changes of fasting and postprandial 2-h glucose concentration, and the proportion of patients achieving a reduction in HbA1c >0.5%.

Results

In the intention-to-treat analysis, ginsam treatment reduced HbA1c level significantly: -0.56 ± 0.25% in the 1500 mg group, -0.31 ± 0.12% in the 2000 mg group, and -0.29 ± 0.11% in the 3000 mg group (all P < 0.05), with a significant difference between the 1500 mg ginsam and the placebo group (-0.02 ± 0.12%, P = 0.021). The changes in fasting glucose concentration followed the same pattern: -21.40, -14.27 and -6.76 mg/dL for 1500, 2000, and 3000 mg, respectively, vs -2.25 mg/dL for the placebo. The percentage of patients whose HbA1c level decreased by >0.5% differed significantly between the placebo group (11.1%) and the 1500 mg (27.8%) and 2000 mg (27.8%) groups. No severe adverse events were observed in any group.

Conclusions

An 8-week treatment with ginsam, a vinegar extract from P. ginseng, moderately improved HbA1c level and was well tolerated in type 2 diabetic patients with inadequate glycemic control. This trial was registered with ClinicalTrial.Gov (no. NCT01008163). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00185.x, 2011).

SUBMITTER: Yoon JW

PROVIDER: S-EPMC4014955 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Efficacy and safety of ginsam, a vinegar extract from Panax ginseng, in type 2 diabetic patients: Results of a double-blind, placebo-controlled study.

Yoon Ji Won JW Kang Seon Mee SM Vassy Jason L JL Shin Hayley H Lee Yun Hee YH Ahn Hwa Young HY Choi Sung Hee SH Park Kyong Soo KS Jang Hak Chul HC Lim Soo S

Journal of diabetes investigation 20120601 3

<h4>Unlabelled</h4>Aims/Introduction: The efficacy, dose-response relationship and safety of ginsam, a vinegar extract from Panax ginseng, were evaluated in an 8-week, double-blind, randomized, placebo-controlled study in drug-naïve patients with type 2 diabetes.<h4>Materials and methods</h4> A total of 72 diabetic patients were randomized to receive 1500, 2000 or 3000 mg of ginsam, or placebo daily for 8 weeks (n = 18 in each group). The primary end-point was the changes from the baseline HbA ...[more]

PMID: 24843582

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Project description:BackgroundGS-3K8 and GINST, both of which are modified ginseng extracts, have never been examined in terms of their effectiveness for the prevention of acute respiratory illness (ARI) in humans. We conducted a pilot study to assess the feasibility of performing a large-scale, randomized, controlled trial.MethodsThis study was a randomized, double-blind, placebo-controlled, pilot study at a single center from October 2014 to March 2015. The 45 healthy applicants were randomly divided into the GS-3K8 (n = 15), GINST (n = 15), and placebo groups (n = 15). The study drug was administered as a capsule (500 mg/cap and 3000 mg/day). GS-3K8 contained 6.31 mg/g of Rg1, 15.05 mg/g of Re, 30.84 mg/g of Rb1, 15.02 mg/g of Rc, 12.44 mg/g of Rb2, 6.97 mg/g of Rd, 1.59 mg/g of Rg3, 3.25 mg/g of Rk1, and 4.84 mg/g of Rg5. GINST contained 7.54 mg/g of Rg1, 1.87 mg/g of Re, 5.42 mg/g of Rb1, 0.29 mg/g of Rc, 0.36 mg/g of Rb2, 0.70 mg/g of Rd, and 6.3 mg/g of compound K. The feasibility criteria were the rates of recruitment, drug compliance, and successful follow-up. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measures were the duration of symptoms.ResultsThe rate of recruitment was 11.3 participants per week. The overall rate of completed follow-up was 97.8%. The mean compliance rate was 91.64 ± 9.80%, 95.28 ± 5.75%, and 89.70 ± 8.99% in the GS-3K8, GINST, and placebo groups, respectively. The incidence of ARI was 64.3% (9/14; 95% confidence interval [CI], 31.4-91.1%), 26.7% (4/15; 95% CI, 4.3-49.0%), and 80.0% (12/15; 95% CI, 54.8-93.0%) in the GS-3K8, GINST, and placebo groups, respectively. The average days of symptoms were 3.89 ± 4.65, 9.25 ± 7.63, and 12.25 ± 12.69 in the GS-3K8, GINST, and placebo groups, respectively.ConclusionThe results support the feasibility of a full-scale trial. GS-3K8 and GINST appear to have a positive tendency toward preventing the development of ARI and reducing the symptom duration. A randomized controlled trial is needed to confirm these findings.

Dataset Information

Efficacy and safety of ginsam, a vinegar extract from Panax ginseng, in type 2 diabetic patients: Results of a double-blind, placebo-controlled study.

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Materials and methods

Results

Conclusions

Publications

Efficacy and safety of ginsam, a vinegar extract from Panax ginseng, in type 2 diabetic patients: Results of a double-blind, placebo-controlled study.

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