Acute and Subchronic Oral Toxicity Study of Polyherbal Formulation Containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol. ex. Maton in Rats
The polyherbal formulation containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol ex. Maton has been used for hypertension treatment empirically. Our previous study showed its blood pressure-lowering effect on a rat model of hypertensio...
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| creator | Santosa, D. Koketsu, Mamoru Jumina, Jumina Widyarini, S. Sugiyono, S. Purwono, S. Yuliani, F. S. Nugrahaningsih, D. A. A. Mustofa, M. Sholikhah, E. N. Ngatidjan, N. |
| description | The polyherbal formulation containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol ex. Maton has been used for hypertension treatment empirically. Our previous study showed its blood pressure-lowering effect on a rat model of hypertension. However, toxicity data were not available for this polyherbal formulation. This study is aimed at evaluating the acute and subchronic oral toxicity of the polyherbal formulation in rats. The acute toxicity study was conducted on 6 female Wistar rats using the fixed-dose method for the treatment group and 5 female Wistar rats for the control. The single dose of 2,000 mg/kg of the polyherbal formulation was given orally. There were no significant toxic effects and no death observed until the end of the study, and it was showed that the lethal dose 50% (LD50) of the polyherbal formulation was estimated to be more than 2,000 mg/kg. The macroscopic and microscopic examination of vital organs showed no symptoms of toxicity. At the subchronic toxicity study, the polyherbal formulation with 3 dose variations of 252 mg/kg, 1,008 mg/kg, and 4,032 mg/kg was administered for 91 days orally. The lowest dose of 252 mg/kg is equivalent to the daily recommended dose for a human. There were no significant toxic effects observed at all doses on physical sign and symptoms, weight gain, food intake, hematological parameters, biochemical parameters, and macroscopic and microscopic examination of organs. These findings showed that the short- and long-term oral administration of the polyherbal formulation is safe to use within its dose recommendation. |
| doi_str_mv | 10.1155/2020/8609364 |
| format | Article |
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Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol. ex. Maton in Rats</title><source>MEDLINE</source><source>PubMed Central Open Access</source><source>Wiley-Blackwell Open Access Titles</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Santosa, D. ; Koketsu, Mamoru ; Jumina, Jumina ; Widyarini, S. ; Sugiyono, S. ; Purwono, S. ; Yuliani, F. S. ; Nugrahaningsih, D. A. A. ; Mustofa, M. ; Sholikhah, E. N. ; Ngatidjan, N.</creator><contributor>de Sousa, Damião Pergentino ; Damião Pergentino de Sousa</contributor><creatorcontrib>Santosa, D. ; Koketsu, Mamoru ; Jumina, Jumina ; Widyarini, S. ; Sugiyono, S. ; Purwono, S. ; Yuliani, F. S. ; Nugrahaningsih, D. A. A. ; Mustofa, M. ; Sholikhah, E. N. ; Ngatidjan, N. ; de Sousa, Damião Pergentino ; Damião Pergentino de Sousa</creatorcontrib><description>The polyherbal formulation containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol ex. Maton has been used for hypertension treatment empirically. Our previous study showed its blood pressure-lowering effect on a rat model of hypertension. However, toxicity data were not available for this polyherbal formulation. This study is aimed at evaluating the acute and subchronic oral toxicity of the polyherbal formulation in rats. The acute toxicity study was conducted on 6 female Wistar rats using the fixed-dose method for the treatment group and 5 female Wistar rats for the control. The single dose of 2,000 mg/kg of the polyherbal formulation was given orally. There were no significant toxic effects and no death observed until the end of the study, and it was showed that the lethal dose 50% (LD50) of the polyherbal formulation was estimated to be more than 2,000 mg/kg. The macroscopic and microscopic examination of vital organs showed no symptoms of toxicity. At the subchronic toxicity study, the polyherbal formulation with 3 dose variations of 252 mg/kg, 1,008 mg/kg, and 4,032 mg/kg was administered for 91 days orally. The lowest dose of 252 mg/kg is equivalent to the daily recommended dose for a human. There were no significant toxic effects observed at all doses on physical sign and symptoms, weight gain, food intake, hematological parameters, biochemical parameters, and macroscopic and microscopic examination of organs. These findings showed that the short- and long-term oral administration of the polyherbal formulation is safe to use within its dose recommendation.</description><identifier>ISSN: 2314-6133</identifier><identifier>EISSN: 2314-6141</identifier><identifier>DOI: 10.1155/2020/8609364</identifier><identifier>PMID: 32309440</identifier><language>eng</language><publisher>Cairo, Egypt: Hindawi Publishing Corporation</publisher><subject>Acute toxicity ; Agricultural industry ; Allium sativum ; Amomum - chemistry ; Amomum compactum ; Animal models ; Animals ; Antihypertensives ; Blood pressure ; Body Weight ; Body weight gain ; Curcuma ; Curcuma - chemistry ; Disease Models, Animal ; Drug dosages ; Eating ; Female ; Food intake ; Garlic ; Garlic - chemistry ; Hematology ; Herbal medicine ; Hypertension ; Laboratories ; Lethal dose ; Lethal Dose 50 ; Liver - drug effects ; Liver - pathology ; Male ; Medical research ; Oral administration ; Organs ; Parameters ; Plant Extracts - toxicity ; Pressure effects ; Public health ; Rats ; Rats, Wistar ; Terminalia - chemistry ; Terminalia bellirica ; Toxicity ; Toxicity Tests, Acute</subject><ispartof>BioMed research international, 2020, Vol.2020 (2020), p.1-18</ispartof><rights>Copyright © 2020 E. N. Sholikhah et al.</rights><rights>COPYRIGHT 2020 John Wiley & Sons, Inc.</rights><rights>Copyright © 2020 E. N. Sholikhah et al. This is an open access article distributed under the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. http://creativecommons.org/licenses/by/4.0</rights><rights>Copyright © 2020 E. N. Sholikhah et al. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c499t-c06748d28b43dff1e11c1637f9907d89531e08a5574af0b764ad92fe1af51b2f3</citedby><cites>FETCH-LOGICAL-c499t-c06748d28b43dff1e11c1637f9907d89531e08a5574af0b764ad92fe1af51b2f3</cites><orcidid>0000-0002-6545-8691</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7136774/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7136774/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,4023,27922,27923,27924,53790,53792</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32309440$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>de Sousa, Damião Pergentino</contributor><contributor>Damião Pergentino de Sousa</contributor><creatorcontrib>Santosa, D.</creatorcontrib><creatorcontrib>Koketsu, Mamoru</creatorcontrib><creatorcontrib>Jumina, Jumina</creatorcontrib><creatorcontrib>Widyarini, S.</creatorcontrib><creatorcontrib>Sugiyono, S.</creatorcontrib><creatorcontrib>Purwono, S.</creatorcontrib><creatorcontrib>Yuliani, F. S.</creatorcontrib><creatorcontrib>Nugrahaningsih, D. A. A.</creatorcontrib><creatorcontrib>Mustofa, M.</creatorcontrib><creatorcontrib>Sholikhah, E. N.</creatorcontrib><creatorcontrib>Ngatidjan, N.</creatorcontrib><title>Acute and Subchronic Oral Toxicity Study of Polyherbal Formulation Containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol. ex. Maton in Rats</title><title>BioMed research international</title><addtitle>Biomed Res Int</addtitle><description>The polyherbal formulation containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol ex. Maton has been used for hypertension treatment empirically. Our previous study showed its blood pressure-lowering effect on a rat model of hypertension. However, toxicity data were not available for this polyherbal formulation. This study is aimed at evaluating the acute and subchronic oral toxicity of the polyherbal formulation in rats. The acute toxicity study was conducted on 6 female Wistar rats using the fixed-dose method for the treatment group and 5 female Wistar rats for the control. The single dose of 2,000 mg/kg of the polyherbal formulation was given orally. There were no significant toxic effects and no death observed until the end of the study, and it was showed that the lethal dose 50% (LD50) of the polyherbal formulation was estimated to be more than 2,000 mg/kg. The macroscopic and microscopic examination of vital organs showed no symptoms of toxicity. At the subchronic toxicity study, the polyherbal formulation with 3 dose variations of 252 mg/kg, 1,008 mg/kg, and 4,032 mg/kg was administered for 91 days orally. The lowest dose of 252 mg/kg is equivalent to the daily recommended dose for a human. There were no significant toxic effects observed at all doses on physical sign and symptoms, weight gain, food intake, hematological parameters, biochemical parameters, and macroscopic and microscopic examination of organs. These findings showed that the short- and long-term oral administration of the polyherbal formulation is safe to use within its dose recommendation.</description><subject>Acute toxicity</subject><subject>Agricultural industry</subject><subject>Allium sativum</subject><subject>Amomum - chemistry</subject><subject>Amomum compactum</subject><subject>Animal models</subject><subject>Animals</subject><subject>Antihypertensives</subject><subject>Blood pressure</subject><subject>Body Weight</subject><subject>Body weight gain</subject><subject>Curcuma</subject><subject>Curcuma - chemistry</subject><subject>Disease Models, Animal</subject><subject>Drug dosages</subject><subject>Eating</subject><subject>Female</subject><subject>Food intake</subject><subject>Garlic</subject><subject>Garlic - chemistry</subject><subject>Hematology</subject><subject>Herbal medicine</subject><subject>Hypertension</subject><subject>Laboratories</subject><subject>Lethal dose</subject><subject>Lethal Dose 50</subject><subject>Liver - drug effects</subject><subject>Liver - pathology</subject><subject>Male</subject><subject>Medical research</subject><subject>Oral administration</subject><subject>Organs</subject><subject>Parameters</subject><subject>Plant Extracts - toxicity</subject><subject>Pressure effects</subject><subject>Public health</subject><subject>Rats</subject><subject>Rats, Wistar</subject><subject>Terminalia - chemistry</subject><subject>Terminalia bellirica</subject><subject>Toxicity</subject><subject>Toxicity Tests, Acute</subject><issn>2314-6133</issn><issn>2314-6141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>RHX</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkktrGzEUhYfS0oQ0u66LoJuWxI6e89gUjGnSgktK7K7FHY1kK8xIjkaT2v8xP6oydpx2V23uRefjcLicLHtP8JgQIa4opviqzHHFcv4qO6WM8FFOOHl93Bk7yc77_h6nV5JE5m-zE0YZrjjHp9nTRA1RI3ANmg-1WgXvrEK3AVq08BurbNyieRyaLfIG_fTtdqVDncRrH7qhhWi9Q1PvIlhn3RJN2tYOHeqT8JjmbHyJFjp01kFrAdU6ycEqQJ9uQIfoxp_Rnd_UiZoOQQ0doPQ9LK3zPTwru2iTznfJTvluDSqmbe7bMdKbMfoBMSWwDt1B7N9lbwy0vT4_zLPs1_XXxfTbaHZ78306mY0Ur6o4UjgveNnQsuasMYZoQhTJWWGqChdNWQlGNC5BiIKDwXWRc2gqajQBI0hNDTvLvux910Pd6UZpF9PB5DrYDsJWerDyX8XZlVz6R1kQlhcFTwYfDwbBPwy6j_LeDyEdqZeU46rApOT0hVpCq6V1xicz1dleyUlOBWWCC5Goyz2lgu_7oM0xB8FyVxK5K4k8lCThH_7OfoSfK5GAiz2wsq6B3_Y_7XRitIEXmrBC5Jj9AWiszuo</recordid><startdate>2020</startdate><enddate>2020</enddate><creator>Santosa, D.</creator><creator>Koketsu, Mamoru</creator><creator>Jumina, Jumina</creator><creator>Widyarini, S.</creator><creator>Sugiyono, S.</creator><creator>Purwono, S.</creator><creator>Yuliani, F. 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Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol. ex. Maton in Rats</title><author>Santosa, D. ; Koketsu, Mamoru ; Jumina, Jumina ; Widyarini, S. ; Sugiyono, S. ; Purwono, S. ; Yuliani, F. S. ; Nugrahaningsih, D. A. A. ; Mustofa, M. ; Sholikhah, E. 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S.</au><au>Nugrahaningsih, D. A. A.</au><au>Mustofa, M.</au><au>Sholikhah, E. N.</au><au>Ngatidjan, N.</au><au>de Sousa, Damião Pergentino</au><au>Damião Pergentino de Sousa</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Acute and Subchronic Oral Toxicity Study of Polyherbal Formulation Containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol. ex. Maton in Rats</atitle><jtitle>BioMed research international</jtitle><addtitle>Biomed Res Int</addtitle><date>2020</date><risdate>2020</risdate><volume>2020</volume><issue>2020</issue><spage>1</spage><epage>18</epage><pages>1-18</pages><issn>2314-6133</issn><eissn>2314-6141</eissn><abstract>The polyherbal formulation containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol ex. Maton has been used for hypertension treatment empirically. Our previous study showed its blood pressure-lowering effect on a rat model of hypertension. However, toxicity data were not available for this polyherbal formulation. This study is aimed at evaluating the acute and subchronic oral toxicity of the polyherbal formulation in rats. The acute toxicity study was conducted on 6 female Wistar rats using the fixed-dose method for the treatment group and 5 female Wistar rats for the control. The single dose of 2,000 mg/kg of the polyherbal formulation was given orally. There were no significant toxic effects and no death observed until the end of the study, and it was showed that the lethal dose 50% (LD50) of the polyherbal formulation was estimated to be more than 2,000 mg/kg. The macroscopic and microscopic examination of vital organs showed no symptoms of toxicity. At the subchronic toxicity study, the polyherbal formulation with 3 dose variations of 252 mg/kg, 1,008 mg/kg, and 4,032 mg/kg was administered for 91 days orally. The lowest dose of 252 mg/kg is equivalent to the daily recommended dose for a human. There were no significant toxic effects observed at all doses on physical sign and symptoms, weight gain, food intake, hematological parameters, biochemical parameters, and macroscopic and microscopic examination of organs. These findings showed that the short- and long-term oral administration of the polyherbal formulation is safe to use within its dose recommendation.</abstract><cop>Cairo, Egypt</cop><pub>Hindawi Publishing Corporation</pub><pmid>32309440</pmid><doi>10.1155/2020/8609364</doi><tpages>18</tpages><orcidid>https://orcid.org/0000-0002-6545-8691</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2314-6133 |
| ispartof | BioMed research international, 2020, Vol.2020 (2020), p.1-18 |
| issn | 2314-6133 2314-6141 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7136774 |
| source | MEDLINE; PubMed Central Open Access; Wiley-Blackwell Open Access Titles; PubMed Central; Alma/SFX Local Collection |
| subjects | Acute toxicity Agricultural industry Allium sativum Amomum - chemistry Amomum compactum Animal models Animals Antihypertensives Blood pressure Body Weight Body weight gain Curcuma Curcuma - chemistry Disease Models, Animal Drug dosages Eating Female Food intake Garlic Garlic - chemistry Hematology Herbal medicine Hypertension Laboratories Lethal dose Lethal Dose 50 Liver - drug effects Liver - pathology Male Medical research Oral administration Organs Parameters Plant Extracts - toxicity Pressure effects Public health Rats Rats, Wistar Terminalia - chemistry Terminalia bellirica Toxicity Toxicity Tests, Acute |
| title | Acute and Subchronic Oral Toxicity Study of Polyherbal Formulation Containing Allium sativum L., Terminalia bellirica (Gaertn.) Roxb., Curcuma aeruginosa Roxb., and Amomum compactum Sol. ex. Maton in Rats |
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