Advertisement

Advances in Therapy

, Volume 27, Issue 4, pp 250–255 | Cite as

Oral dose-ranging developmental toxicity study of an herbal supplement (NT) and gallic acid in rats

  • Anthony Booth
  • Ronald J. Amen
  • Michael Scott
  • Frank L. GreenwayEmail author
Original Research

Abstract

Objective

To evaluate the combination of rhubarb, astragalus, red sage, ginger, and turmeric (mixture referred to as “NT”) together with gallic acid for evidence of reproductive toxicity in rats.

Methods

Fifty virgin female rats were cohabited with male rats. Day 0 of potential pregnancy was evidence of spermatozoa on vaginal smear. The presumably pregnant rats were randomized to five groups of 10 individuals and were fed by daily gavage on days 6–20 of presumed gestation with one of the following: deionized water placebo, 21.6 mg/kg per day, 215 mg/kg per day, 430 mg/kg per day, or 860 mg/kg per day of a mixture of NT (20%) and gallic acid (80%). Cesarean section was performed on day 21.

Results

All 50 rats had one or more live fetuses and survived until they were killed. Body weight was reduced in the 860 mg/kg per day group compared with placebo: mean (SD), 406.8 (23.0) vs. 430.1 (27.7) g, P<0.05. There were no dose-related adverse events or differences between groups in uterine size, food intake, corpora lutea, implantations, litter size, number of live fetuses, and gender distribution of fetuses or fetal resorptions. There were no dead fetuses, and all placentae appeared normal. All rats and tissues were normal at necropsy. Fetal weights did not differ between groups, and there were no fetal abnormalities.

Conclusion

The combination of NT and gallic acid gave no evidence of reproductive toxicity at 430 mg/kg per day or below, which is reassuring should this combination be used in the future as a dietary herbal supplement for the treatment of obesity.

Keywords

astragalus gallic acid ginger red sage reproduction rhubarb toxicity turmeric 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Wei K, Xu X. Herbal composition and method for controlling body weight and composition. United States Patent 6,541,046, April 1, 2003. Available at: www.freepatentsonline.com/6541046.html. Accessed: April 1, 2010.Google Scholar
  2. 2.
    York DA, Sonyja Thomas, Greenway FL, Liu Z, Rood JC. Effect of an herbal extract Number Ten (NT) on body weight in rats. Chin Med. 2006;2:10.CrossRefGoogle Scholar
  3. 3.
    Greenway FL, Liu Z, Martin CK, Rood JC, Yu Y, Amen RJ. Safety and efficacy of NT, an herbal supplement, in treating human obesity. Int J Obes (Lond). 2006;30:1737–1741.CrossRefGoogle Scholar
  4. 4.
    Glick Z. Modes of action of gallic acid in suppressing food intake of rats. J Nutr. 1981;111:1910–1916.PubMedGoogle Scholar
  5. 5.
    Niho N, Shibutani M, Tamura T, et al. Subchronic toxicity study of gallic acid by oral administration in F344 rats. Food Chem Toxicol. 2001;39:1063–1070.CrossRefPubMedGoogle Scholar
  6. 6.
    Liu Z, Schwimer J, Liu D, Greenway FL, Anthony CT, Woltering EA. Black raspberry extract and fractions contain angiogenesis inhibitors. J Agric Food Chem. 2005;53:3909–3015.CrossRefPubMedGoogle Scholar
  7. 7.
    Good Laboratory Practices (GLP) for Non-Clinical Laboratory Studies 21 CFR Part 58. Available at: www.fda.gov/ohrms/dockets/98fr/980335s1.PDF. Accessed: April 1, 2010.Google Scholar
  8. 8.
    National Research Council, Institute of Laboratory Animal Resources. Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academy Press; 1996.Google Scholar
  9. 9.
    Rupnick MA, Panigrahy D, Zhang CY, et al. Adipose tissue mass can be regulated through the vasculature. Proc Natl Acad Sci U S A. 2002; 99:10730–10735.CrossRefPubMedGoogle Scholar
  10. 10.
    Son MJ, Kim JS, Kim MH, et al. Combination treatment with temozolomide and thalidomide inhibits tumor growth and angiogenesis in an orthotopic glioma model. Int J Oncol. 2006;28:53–59.PubMedGoogle Scholar
  11. 11.
    Uhl K, Kennedy DL, Kweder SL. Risk management strategies in the Physicians’ Desk Reference product labels for pregnancy category X drugs. Drug Saf. 2002;25:885–892.CrossRefPubMedGoogle Scholar
  12. 12.
    Parman T, Wiley MJ, Wells PG. Free radical-mediated oxidative DNA damage in the mechanism of thalidomide teratogenicity. Nat Med. 1999;5:582–285.CrossRefPubMedGoogle Scholar

Copyright information

© Springer Healthcare 2010

Authors and Affiliations

  • Anthony Booth
    • 1
  • Ronald J. Amen
    • 2
  • Michael Scott
    • 3
  • Frank L. Greenway
    • 4
    Email author
  1. 1.WestLake PartnersChesterUSA
  2. 2.WestLake PartnersVilla ParkUSA
  3. 3.ATOX Research, Inc.San FranciscoUSA
  4. 4.Pennington Biomedical Research CenterLouisiana State University SystemBaton RougeUSA

Personalised recommendations