A 13-Week Repeated Oral Dose Toxicity Study of ChondroT in Sprague-Dawley Rats.
13-week repeated oral dose toxicity
4-week recovery test
ChondroT
NOAEL
Journal
BMC complementary and alternative medicine
ISSN: 1472-6882
Titre abrégé: BMC Complement Altern Med
Pays: England
ID NLM: 101088661
Informations de publication
Date de publication:
12 Dec 2019
12 Dec 2019
Historique:
received:
26
02
2019
accepted:
26
11
2019
entrez:
14
12
2019
pubmed:
14
12
2019
medline:
23
1
2020
Statut:
epublish
Résumé
ChondroT, a new herbal medication, consists of Angelica grosseserrata Maxim., Lonicera japonica Thunb., Angelica gigas Nakai, Clematis terniflora var. manshurica (Rupr.) Ohwi, and Phellodendron amurense Rupr. (6:4:4:4:3). Our previous studies have shown that ChondroT exhibits significant anti-arthritic and anti-inflammatory effects. In this study, we aimed to assess the toxicological safety assessment of ChondroT. This study was designed to assess the safety of ChondroT after repeated oral administration. Male and female Sprague-Dawley rats were treated with ChondroT at oral doses of 0, 500, 1000, and 2000 mg/kg for 13 weeks. Mortality, clinical signs, body weight changes, food consumption, ophthalmological findings, urinalysis, hematological and blood-chemical parameters, necropsy findings, organ weights, and histological markers were recorded throughout the study period. Rats were also monitored for an additional 4 weeks to determine the recovery time. No death occurred and no significant changes in food consumption, ophthalmologic findings, and urinalysis were found. Although there were alterations in clinical signs, body weights, hematological parameters, blood-chemical parameters, necropsy findings, organ weights, and histological markers, they were not considered to be toxicologically significant. The results suggest that the no-observed adverse effects level (NOAEL) was 2000 mg/kg/day for the test substance. ChondroT, a new complex herbal medication composed of five plants, can therefore be used safely at the NOAEL.
Sections du résumé
BACKGROUND
BACKGROUND
ChondroT, a new herbal medication, consists of Angelica grosseserrata Maxim., Lonicera japonica Thunb., Angelica gigas Nakai, Clematis terniflora var. manshurica (Rupr.) Ohwi, and Phellodendron amurense Rupr. (6:4:4:4:3). Our previous studies have shown that ChondroT exhibits significant anti-arthritic and anti-inflammatory effects. In this study, we aimed to assess the toxicological safety assessment of ChondroT.
METHODS
METHODS
This study was designed to assess the safety of ChondroT after repeated oral administration. Male and female Sprague-Dawley rats were treated with ChondroT at oral doses of 0, 500, 1000, and 2000 mg/kg for 13 weeks. Mortality, clinical signs, body weight changes, food consumption, ophthalmological findings, urinalysis, hematological and blood-chemical parameters, necropsy findings, organ weights, and histological markers were recorded throughout the study period. Rats were also monitored for an additional 4 weeks to determine the recovery time.
RESULTS
RESULTS
No death occurred and no significant changes in food consumption, ophthalmologic findings, and urinalysis were found. Although there were alterations in clinical signs, body weights, hematological parameters, blood-chemical parameters, necropsy findings, organ weights, and histological markers, they were not considered to be toxicologically significant.
CONCLUSIONS
CONCLUSIONS
The results suggest that the no-observed adverse effects level (NOAEL) was 2000 mg/kg/day for the test substance. ChondroT, a new complex herbal medication composed of five plants, can therefore be used safely at the NOAEL.
Identifiants
pubmed: 31830971
doi: 10.1186/s12906-019-2773-4
pii: 10.1186/s12906-019-2773-4
pmc: PMC6909520
doi:
Substances chimiques
Plant Extracts
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
367Subventions
Organisme : the Ministry of Health & Welfare, Republic of Korea
ID : HI17C0911
Références
BMC Complement Altern Med. 2016 Jul 13;16:213
pubmed: 27411719
Vet Pathol. 2010 Jan;47(1):137-9
pubmed: 20080494
BMC Complement Altern Med. 2013 Feb 26;13:47
pubmed: 23442977
Medicine (Baltimore). 2018 Mar;97(12):e0170
pubmed: 29561428
Evid Based Complement Alternat Med. 2016;2016:1230294
pubmed: 27382402
Evid Based Complement Alternat Med. 2018 Feb 8;2018:8565132
pubmed: 29576802
Ther Adv Musculoskelet Dis. 2012 Aug;4(4):259-67
pubmed: 22859925
FASEB J. 2008 Mar;22(3):659-61
pubmed: 17942826
Database (Oxford). 2016 Mar 15;2016:null
pubmed: 26980517
Ann Rheum Dis. 2008 Jan;67(1):5-10
pubmed: 18077542
Lancet. 2011 Jun 18;377(9783):2115-26
pubmed: 21684382
Ann Rheum Dis. 2010 Mar;69(3):483-9
pubmed: 19762361
Pharmazie. 2009 Dec;64(12):836-9
pubmed: 20095144
Toxicol Pathol. 1992;20(3 Pt 1):327-40
pubmed: 1295064
BMC Complement Altern Med. 2019 Jan 8;19(1):10
pubmed: 30621705
BMC Complement Altern Med. 2018 Apr 19;18(1):131
pubmed: 29673343
Ann Rheum Dis. 2005 Nov;64(11):1539-41
pubmed: 16107512
J Rheumatol Suppl. 1991 Feb;27:10-2
pubmed: 2027107
Molecules. 2018 Jan 20;23(1):null
pubmed: 29361716