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Acute, Subacute, and Genotoxicity Assessments of a Proprietary Blend of Garcinia mangostana Fruit Rind and Cinnamomum tamala Leaf Extracts (CinDura®).

ABSTRACT: The present communication describes a battery of toxicity studies that include an acute oral toxicity, a subacute twenty-eight-day repeated oral dose toxicity, and genotoxicity studies on a herbal formulation CinDura® (GMCT). This proprietary herbal composition contains the extracts of the Garcinia mangostana fruit rind (GM) and the Cinnamomum tamala leaf (CT). The toxicological evaluations were performed following the Organization for Economic Cooperation and Development (OECD) guidelines. The acute oral toxicity study in Wistar rats suggests that the median lethal dose of CinDura® is at least 2000?mg/kg body weight. Acute dermal and eye irritation tests in New Zealand white rabbits indicate that the test item is nonirritant to the skin and eyes. A twenty-eight-day repeated dose oral toxicity study was conducted in male and female Wistar rats using daily doses of 250, 500, and 1000?mg/kg body weight, followed by a fourteen-day reversal period for two satellite groups. The CinDura®-supplemented animals did not show any sign of toxicity on their body weights, organ weights, and on the hematobiochemical parameters. The gross pathology and histopathological examinations indicated no treatment-related changes in the experimental animals. Overall, the no-observed-adverse-effect level (NOAEL) of the herbal blend is 1000?mg/kg body weight, the highest tested dose. Also, the results of the bacterial reverse mutation test and the erythrocyte micronucleus assay in mouse bone marrow suggest that CinDura® (GMCT) is neither mutagenic nor clastogenic.

SUBMITTER: Dodda S

PROVIDER: S-EPMC7414347 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Acute, Subacute, and Genotoxicity Assessments of a Proprietary Blend of Garcinia mangostana Fruit Rind and Cinnamomum tamala Leaf Extracts (CinDura®).

Dodda Sundararaju S Alluri Venkata Krishnaraju VK Golakoti Trimurtulu T Sengupta Krishanu K

Journal of toxicology 20200730

The present communication describes a battery of toxicity studies that include an acute oral toxicity, a subacute twenty-eight-day repeated oral dose toxicity, and genotoxicity studies on a herbal formulation CinDura® (GMCT). This proprietary herbal composition contains the extracts of the Garcinia mangostana fruit rind (GM) and the Cinnamomum tamala leaf (CT). The toxicological evaluations were performed following the Organization for Economic Cooperation and Development (OECD) gu ...[more]

PMID: 32802054

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Project description:BACKGROUND:A proprietary composition GMCT contains extracts of two popular Asian herbs viz., Garcinia mangostana (GM) fruit rind and Cinnamomum tamala (CT) leaf. We systematically evaluated physical performance and muscle strength enhancing ability of GMCT in a preclinical mouse model followed by a 42-days double-blind placebo controlled human trial in resistance trained adult males. METHODS:Four groups of Swiss albino mice (20-30 g body weight) (n?=?6) were fed a standard laboratory diet and given Carboxymethylcellulose sodium (CMC), 150 mg/kg GMCT (GMCT-150), 300 mg/kg GMCT (GMCT-300) or 50 mg/kg Oxymetholone (OXY) via oral gavage for 21 days. On day 22, the animals' physical performance and muscle strength were assessed in a forced swimming test (FST) and forelimb grip strength experiment, respectively. In the human trial, thirty-eight resistance-trained young adults (mean age 26.32?±?4.39 years, body weight 67.79?±?12.84 kg, BMI 22.92?±?3.54 kg/m2) completed the trial. The participants received either GMCT (n?=?19; 800 mg daily) or matched placebo (n?=?19) for 42 days. As primary variables, 1-RM bench press, 1-RM leg press, and leg extension repetitions were measured at baseline and on days 14, 28 and 42 of the intervention. Anthropometric parameters and serum markers such as free testosterone, insulin-like growth factor 1 (IGF-1), insulin and lactate were also measured before and after the intervention. RESULTS:GMCT-300 mice showed significant improvement in swimming time (GMCT: 395.3?±?81.70 s vs. CMC: 271.6?±?56.86 s; p?=?0.0166), distance (GMCT: 341.22?±?65.88 m vs. CMC: 260.84?±?49.15 m; p?=?0.0461) and grip strength (GMCT: 43.92?±?6.97 N vs. CMC: 35.0?±?6.92 N; p?=?0.0490), compared with the CMC group. At the end of the 42-day human trial, the per protocol analyses reveal that mean changes from baseline 1-RM bench press (GMCT: 23.47?±?10.07 kg vs. PL: 3.42?±?2.06 kg; p?<?0.0001), leg press (GMCT: 29.32?±?16.17 kg vs. PL: 5.21?±?1.72 kg; p?<?0.0001), number of leg extension repetitions (GMCT: 6.58?±?2.57 vs. PL: 2.05?±?1.22; p?<?0.0001) in GMCT group were significantly improved, compared with placebo. Intergroup difference analyses show that the changes from baseline left arm (GMCT: 1.09?±?0.36 cm vs. PL: 0.68?±?0.42 cm; p?=?0.0023), right arm (GMCT: 1.50?±?0.44 cm vs. PL: 1.11?±?0.43 cm; p?=?0.0088) circumference and lean mass (GMCT: 2.29?±?2.09 kg vs. PL: 0.52?±?2.58 kg; p?=?0.0404) in GMCT group were also significantly improved, compared with placebo. In comparison to placebo, GMCT supplementation did not improve free testosterone, IGF-1, insulin or lactate levels. Parameters of clinical biochemistry, hematology, urine and vital signs of the participants were within the normal range. CONCLUSION:GMCT supplementation is effective in increasing muscle strength, muscle size and, total lean mass, as well as endurance performance. TRIAL REGISTRATION:Clinical Trial Registry of India (CTRI/2015/01/005374), Registered on Jan 07, 2015; CTRI Website URL - http://ctri.nic.in.

Dataset Information

Acute, Subacute, and Genotoxicity Assessments of a Proprietary Blend of Garcinia mangostana Fruit Rind and Cinnamomum tamala Leaf Extracts (CinDura®).

Publications

Acute, Subacute, and Genotoxicity Assessments of a Proprietary Blend of <i>Garcinia mangostana</i> Fruit Rind and <i>Cinnamomum tamala</i> Leaf Extracts (CinDura®).

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