Study of the safety of oral Triphala aqueous extract on healthy volunteers

Triphala extract is a well known medicinal herbal formula which is usually prescribed by Thai traditional doctors to adjust the physiological functions of the body. Previous studies have reported that Triphala has antioxidant, anti-inflammatory, antihypercholesterolemia and anticancer properties. Th...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Journal of integrative medicine 2020-01, Vol.18 (1), p.35-40
Hauptverfasser: Phetkate, Pratya, Kummalue, Tanawan, Rinthong, Prasob-orn, Kietinun, Somboon, Sriyakul, Kusuma
Format: Artikel
Sprache:eng
Schlagworte:
Online-Zugang:Volltext
Tags: Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
container_end_page 40
container_issue 1
container_start_page 35
container_title Journal of integrative medicine
container_volume 18
creator Phetkate, Pratya
Kummalue, Tanawan
Rinthong, Prasob-orn
Kietinun, Somboon
Sriyakul, Kusuma
description Triphala extract is a well known medicinal herbal formula which is usually prescribed by Thai traditional doctors to adjust the physiological functions of the body. Previous studies have reported that Triphala has antioxidant, anti-inflammatory, antihypercholesterolemia and anticancer properties. Though this herbal recipe is commonly used in Thailand, its human safety, especially in the oral form, has not been studied. We therefore conducted a clinical trial (Phase I). This study evaluated the safety of administering the aqueous extract of Triphala to healthy volunteers at 2500 mg/d. An open-label, single-arm trial was conducted at Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand, between July 2017 and July 2018. The study enrolled 10 male and 10 female healthy volunteers; all were given Triphala (water extract; five capsules of 500 mg each) orally, once a day, at bedtime, for four consecutive weeks. Signs and symptoms, physical examinations, hematology and blood chemistry were assessed at the beginning of the trial and every week thereafter, for four consecutive weeks. After finishing the trial, on day 28, all volunteers were invited to a follow-up session on day 35 to evaluate the safety of the herbal recipe using the same measurements. At the oral dose of 2500 mg/d, Triphala had no serious adverse effects in healthy volunteers. Moreover, it was found to have significantly improved the volunteers’ high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35. We conclude that aqueous extract of Triphala is safe for healthy volunteers and that it elevates HDL-C levels and lowers blood sugar. Further clinical study should investigate its effects on HDL-C and blood sugar levels among the dyslipidemic and prediabetic groups. This trial was registered in the Thai Clinical Trial Registry with the identifier TCTR20180423002.
doi_str_mv 10.1016/j.joim.2019.10.002
format Article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2311921802</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S2095496419301001</els_id><sourcerecordid>2311921802</sourcerecordid><originalsourceid>FETCH-LOGICAL-c356t-43f5abcc914a16d81c1b442cd99e2a8197fe1bece2b99eb496db0bf48a18f8df3</originalsourceid><addsrcrecordid>eNp9UMtOwzAQ9AFEq9If4IB85JJgOw9siQuqeKoSB8rZcpy1kiiJi-1U9O9J2sKRvax2NDuaGYSuKIkpofltEze27mJGqBiBmBB2huaMiCxKRZ7O0NL7hozD8zxLxAWaJTTnhGTJHL19hKHcY2twqAB7ZSAcLutUizeu3laqVVh9DWAHj-E7OKUDtj2uQLWh2uOdbYc-ADh_ic6Naj0sT3uBPp8eN6uXaP3-_Lp6WEc6yfIQpYnJVKG1oKmiecmppkWaMl0KAUxxKu4M0AI0sGJEijFBWZDCpFxRbnhpkgW6OepunR19-SC72mtoW9VPJiVLKBWMcsJGKjtStbPeOzBy6-pOub2kRE7VyUZO1cmpugkjh6frk_5QdFD-vfyWNhLujwQYU-5qcNLrGnoNZe1AB1na-j_9H9vYgoc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2311921802</pqid></control><display><type>article</type><title>Study of the safety of oral Triphala aqueous extract on healthy volunteers</title><source>MEDLINE</source><source>Alma/SFX Local Collection</source><creator>Phetkate, Pratya ; Kummalue, Tanawan ; Rinthong, Prasob-orn ; Kietinun, Somboon ; Sriyakul, Kusuma</creator><creatorcontrib>Phetkate, Pratya ; Kummalue, Tanawan ; Rinthong, Prasob-orn ; Kietinun, Somboon ; Sriyakul, Kusuma</creatorcontrib><description>Triphala extract is a well known medicinal herbal formula which is usually prescribed by Thai traditional doctors to adjust the physiological functions of the body. Previous studies have reported that Triphala has antioxidant, anti-inflammatory, antihypercholesterolemia and anticancer properties. Though this herbal recipe is commonly used in Thailand, its human safety, especially in the oral form, has not been studied. We therefore conducted a clinical trial (Phase I). This study evaluated the safety of administering the aqueous extract of Triphala to healthy volunteers at 2500 mg/d. An open-label, single-arm trial was conducted at Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand, between July 2017 and July 2018. The study enrolled 10 male and 10 female healthy volunteers; all were given Triphala (water extract; five capsules of 500 mg each) orally, once a day, at bedtime, for four consecutive weeks. Signs and symptoms, physical examinations, hematology and blood chemistry were assessed at the beginning of the trial and every week thereafter, for four consecutive weeks. After finishing the trial, on day 28, all volunteers were invited to a follow-up session on day 35 to evaluate the safety of the herbal recipe using the same measurements. At the oral dose of 2500 mg/d, Triphala had no serious adverse effects in healthy volunteers. Moreover, it was found to have significantly improved the volunteers’ high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35. We conclude that aqueous extract of Triphala is safe for healthy volunteers and that it elevates HDL-C levels and lowers blood sugar. Further clinical study should investigate its effects on HDL-C and blood sugar levels among the dyslipidemic and prediabetic groups. This trial was registered in the Thai Clinical Trial Registry with the identifier TCTR20180423002.</description><identifier>ISSN: 2095-4964</identifier><identifier>DOI: 10.1016/j.joim.2019.10.002</identifier><identifier>PMID: 31680053</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adult ; Biomarkers, Pharmacological - blood ; Capsules ; Clinical trial ; Drug Monitoring - methods ; Female ; Fruit - chemistry ; Healthy Volunteers ; Humans ; Male ; Plant Extracts - administration &amp; dosage ; Prospective Studies ; Safety ; Thailand ; Triphala ; Young Adult</subject><ispartof>Journal of integrative medicine, 2020-01, Vol.18 (1), p.35-40</ispartof><rights>2019</rights><rights>Copyright © 2019. Published by Elsevier B.V.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-43f5abcc914a16d81c1b442cd99e2a8197fe1bece2b99eb496db0bf48a18f8df3</citedby><cites>FETCH-LOGICAL-c356t-43f5abcc914a16d81c1b442cd99e2a8197fe1bece2b99eb496db0bf48a18f8df3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31680053$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Phetkate, Pratya</creatorcontrib><creatorcontrib>Kummalue, Tanawan</creatorcontrib><creatorcontrib>Rinthong, Prasob-orn</creatorcontrib><creatorcontrib>Kietinun, Somboon</creatorcontrib><creatorcontrib>Sriyakul, Kusuma</creatorcontrib><title>Study of the safety of oral Triphala aqueous extract on healthy volunteers</title><title>Journal of integrative medicine</title><addtitle>J Integr Med</addtitle><description>Triphala extract is a well known medicinal herbal formula which is usually prescribed by Thai traditional doctors to adjust the physiological functions of the body. Previous studies have reported that Triphala has antioxidant, anti-inflammatory, antihypercholesterolemia and anticancer properties. Though this herbal recipe is commonly used in Thailand, its human safety, especially in the oral form, has not been studied. We therefore conducted a clinical trial (Phase I). This study evaluated the safety of administering the aqueous extract of Triphala to healthy volunteers at 2500 mg/d. An open-label, single-arm trial was conducted at Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand, between July 2017 and July 2018. The study enrolled 10 male and 10 female healthy volunteers; all were given Triphala (water extract; five capsules of 500 mg each) orally, once a day, at bedtime, for four consecutive weeks. Signs and symptoms, physical examinations, hematology and blood chemistry were assessed at the beginning of the trial and every week thereafter, for four consecutive weeks. After finishing the trial, on day 28, all volunteers were invited to a follow-up session on day 35 to evaluate the safety of the herbal recipe using the same measurements. At the oral dose of 2500 mg/d, Triphala had no serious adverse effects in healthy volunteers. Moreover, it was found to have significantly improved the volunteers’ high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35. We conclude that aqueous extract of Triphala is safe for healthy volunteers and that it elevates HDL-C levels and lowers blood sugar. Further clinical study should investigate its effects on HDL-C and blood sugar levels among the dyslipidemic and prediabetic groups. This trial was registered in the Thai Clinical Trial Registry with the identifier TCTR20180423002.</description><subject>Adult</subject><subject>Biomarkers, Pharmacological - blood</subject><subject>Capsules</subject><subject>Clinical trial</subject><subject>Drug Monitoring - methods</subject><subject>Female</subject><subject>Fruit - chemistry</subject><subject>Healthy Volunteers</subject><subject>Humans</subject><subject>Male</subject><subject>Plant Extracts - administration &amp; dosage</subject><subject>Prospective Studies</subject><subject>Safety</subject><subject>Thailand</subject><subject>Triphala</subject><subject>Young Adult</subject><issn>2095-4964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9UMtOwzAQ9AFEq9If4IB85JJgOw9siQuqeKoSB8rZcpy1kiiJi-1U9O9J2sKRvax2NDuaGYSuKIkpofltEze27mJGqBiBmBB2huaMiCxKRZ7O0NL7hozD8zxLxAWaJTTnhGTJHL19hKHcY2twqAB7ZSAcLutUizeu3laqVVh9DWAHj-E7OKUDtj2uQLWh2uOdbYc-ADh_ic6Naj0sT3uBPp8eN6uXaP3-_Lp6WEc6yfIQpYnJVKG1oKmiecmppkWaMl0KAUxxKu4M0AI0sGJEijFBWZDCpFxRbnhpkgW6OepunR19-SC72mtoW9VPJiVLKBWMcsJGKjtStbPeOzBy6-pOub2kRE7VyUZO1cmpugkjh6frk_5QdFD-vfyWNhLujwQYU-5qcNLrGnoNZe1AB1na-j_9H9vYgoc</recordid><startdate>202001</startdate><enddate>202001</enddate><creator>Phetkate, Pratya</creator><creator>Kummalue, Tanawan</creator><creator>Rinthong, Prasob-orn</creator><creator>Kietinun, Somboon</creator><creator>Sriyakul, Kusuma</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202001</creationdate><title>Study of the safety of oral Triphala aqueous extract on healthy volunteers</title><author>Phetkate, Pratya ; Kummalue, Tanawan ; Rinthong, Prasob-orn ; Kietinun, Somboon ; Sriyakul, Kusuma</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-43f5abcc914a16d81c1b442cd99e2a8197fe1bece2b99eb496db0bf48a18f8df3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Biomarkers, Pharmacological - blood</topic><topic>Capsules</topic><topic>Clinical trial</topic><topic>Drug Monitoring - methods</topic><topic>Female</topic><topic>Fruit - chemistry</topic><topic>Healthy Volunteers</topic><topic>Humans</topic><topic>Male</topic><topic>Plant Extracts - administration &amp; dosage</topic><topic>Prospective Studies</topic><topic>Safety</topic><topic>Thailand</topic><topic>Triphala</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Phetkate, Pratya</creatorcontrib><creatorcontrib>Kummalue, Tanawan</creatorcontrib><creatorcontrib>Rinthong, Prasob-orn</creatorcontrib><creatorcontrib>Kietinun, Somboon</creatorcontrib><creatorcontrib>Sriyakul, Kusuma</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of integrative medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Phetkate, Pratya</au><au>Kummalue, Tanawan</au><au>Rinthong, Prasob-orn</au><au>Kietinun, Somboon</au><au>Sriyakul, Kusuma</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Study of the safety of oral Triphala aqueous extract on healthy volunteers</atitle><jtitle>Journal of integrative medicine</jtitle><addtitle>J Integr Med</addtitle><date>2020-01</date><risdate>2020</risdate><volume>18</volume><issue>1</issue><spage>35</spage><epage>40</epage><pages>35-40</pages><issn>2095-4964</issn><abstract>Triphala extract is a well known medicinal herbal formula which is usually prescribed by Thai traditional doctors to adjust the physiological functions of the body. Previous studies have reported that Triphala has antioxidant, anti-inflammatory, antihypercholesterolemia and anticancer properties. Though this herbal recipe is commonly used in Thailand, its human safety, especially in the oral form, has not been studied. We therefore conducted a clinical trial (Phase I). This study evaluated the safety of administering the aqueous extract of Triphala to healthy volunteers at 2500 mg/d. An open-label, single-arm trial was conducted at Chulabhorn International College of Medicine, Thammasat University, Pathum Thani, Thailand, between July 2017 and July 2018. The study enrolled 10 male and 10 female healthy volunteers; all were given Triphala (water extract; five capsules of 500 mg each) orally, once a day, at bedtime, for four consecutive weeks. Signs and symptoms, physical examinations, hematology and blood chemistry were assessed at the beginning of the trial and every week thereafter, for four consecutive weeks. After finishing the trial, on day 28, all volunteers were invited to a follow-up session on day 35 to evaluate the safety of the herbal recipe using the same measurements. At the oral dose of 2500 mg/d, Triphala had no serious adverse effects in healthy volunteers. Moreover, it was found to have significantly improved the volunteers’ high-density lipoprotein cholesterol (HDL-C) levels on day 35 and also reduced their blood sugar levels on days 14 and 35. We conclude that aqueous extract of Triphala is safe for healthy volunteers and that it elevates HDL-C levels and lowers blood sugar. Further clinical study should investigate its effects on HDL-C and blood sugar levels among the dyslipidemic and prediabetic groups. This trial was registered in the Thai Clinical Trial Registry with the identifier TCTR20180423002.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>31680053</pmid><doi>10.1016/j.joim.2019.10.002</doi><tpages>6</tpages></addata></record>
fulltext fulltext
identifier ISSN: 2095-4964
ispartof Journal of integrative medicine, 2020-01, Vol.18 (1), p.35-40
issn 2095-4964
language eng
recordid cdi_proquest_miscellaneous_2311921802
source MEDLINE; Alma/SFX Local Collection
subjects Adult
Biomarkers, Pharmacological - blood
Capsules
Clinical trial
Drug Monitoring - methods
Female
Fruit - chemistry
Healthy Volunteers
Humans
Male
Plant Extracts - administration & dosage
Prospective Studies
Safety
Thailand
Triphala
Young Adult
title Study of the safety of oral Triphala aqueous extract on healthy volunteers
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T22%3A18%3A43IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Study%20of%20the%20safety%20of%20oral%20Triphala%20aqueous%20extract%20on%20healthy%20volunteers&rft.jtitle=Journal%20of%20integrative%20medicine&rft.au=Phetkate,%20Pratya&rft.date=2020-01&rft.volume=18&rft.issue=1&rft.spage=35&rft.epage=40&rft.pages=35-40&rft.issn=2095-4964&rft_id=info:doi/10.1016/j.joim.2019.10.002&rft_dat=%3Cproquest_cross%3E2311921802%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2311921802&rft_id=info:pmid/31680053&rft_els_id=S2095496419301001&rfr_iscdi=true