Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems
Background and objectives SIVI is a standardized extract prepared using the aerial parts of developed to enhance the quality of sleep. The objective of the present study was to the evaluate efficacy and safety of SIVI ( extract) in the management of stress and sleep problems in Indian particip...
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| Veröffentlicht in: | Curēus (Palo Alto, CA) CA), 2024-03, Vol.16 (3), p.e56530-e56530 |
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| creator | Harit, Mahesh Kumar Mundhe, Narendra Tamoli, Sr, Sanjay Pawar, Vinay Bhapkar, Vedvati Kolhe, Ganesh Mahadik, Swapnali Kulkarni, Anand Agarwal, Ankit |
| description | Background and objectives SIVI is a standardized extract prepared using the aerial parts of
developed to enhance the quality of sleep. The objective of the present study was to the evaluate efficacy and safety of SIVI (
extract) in the management of stress and sleep problems in Indian participants in a randomized, double-blind, placebo-controlled, clinical study. Materials and methods A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI (
extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30. Results
extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI (
extract) group compared to the placebo group on day 15 and day 30. SIVI (
extract) did not show any adverse effects. Conclusions The results of the current study indicate that
extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia. |
| doi_str_mv | 10.7759/cureus.56530 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3043778243</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3043778243</sourcerecordid><originalsourceid>FETCH-LOGICAL-c244t-f4a39b671a938c791fa2aa54615c73be23478eaf53411f5e29b3be30a255b25e3</originalsourceid><addsrcrecordid>eNpdkclP3DAUh62qVQcBt54rS730QMBrnBxhWhYJqSOg6jF68byoHjnx1E4OcOUfx7NQIU5v-96mHyFfODs1Rtdndoo4pVNdask-kAPBy6qoeKU-vvFn5DilFWOMMyOYYZ_JTFalKoVSB-T5DoZl6N0TLk_ojzC1HosL74YcLTxYbEMxD8MYg_cbYp5LzoKn9-O0fKShowtIyXU-RKBusBAHGDdezsfRWbeGYUz0jxv_5paIKdG8j957xDVdxJDX9emIfOrAJzze20Py-_Lnw_y6uP11dTM_vy1sPnUsOgWybkvDoZaVNTXvQABoVXJtjWxRSGUqhE5LxXmnUdRtzkoGQutWaJSH5Ptu7jqGfxOmseldsug9DBim1EimpDGVUDKj396hqzDl3_yWqk2tGK8zdbKjbAwpReyadXQ9xMeGs2ajT7PTp9nqk_Gv-6FT2-PyP_yqhnwB8N6Mig</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3049794019</pqid></control><display><type>article</type><title>Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems</title><source>PubMed Central</source><source>PubMed Central Open Access</source><creator>Harit, Mahesh Kumar ; Mundhe, Narendra ; Tamoli, Sr, Sanjay ; Pawar, Vinay ; Bhapkar, Vedvati ; Kolhe, Ganesh ; Mahadik, Swapnali ; Kulkarni, Anand ; Agarwal, Ankit</creator><creatorcontrib>Harit, Mahesh Kumar ; Mundhe, Narendra ; Tamoli, Sr, Sanjay ; Pawar, Vinay ; Bhapkar, Vedvati ; Kolhe, Ganesh ; Mahadik, Swapnali ; Kulkarni, Anand ; Agarwal, Ankit</creatorcontrib><description>Background and objectives SIVI is a standardized extract prepared using the aerial parts of
developed to enhance the quality of sleep. The objective of the present study was to the evaluate efficacy and safety of SIVI (
extract) in the management of stress and sleep problems in Indian participants in a randomized, double-blind, placebo-controlled, clinical study. Materials and methods A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI (
extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30. Results
extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI (
extract) group compared to the placebo group on day 15 and day 30. SIVI (
extract) did not show any adverse effects. Conclusions The results of the current study indicate that
extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia.</description><identifier>ISSN: 2168-8184</identifier><identifier>EISSN: 2168-8184</identifier><identifier>DOI: 10.7759/cureus.56530</identifier><identifier>PMID: 38646244</identifier><language>eng</language><publisher>United States: Cureus Inc</publisher><subject>Anxiety ; Diabetes ; Fatigue ; Hypertension ; Hypotheses ; Insomnia ; Sleep ; Stress</subject><ispartof>Curēus (Palo Alto, CA), 2024-03, Vol.16 (3), p.e56530-e56530</ispartof><rights>Copyright © 2024, Harit et al.</rights><rights>Copyright © 2024, Harit et al. This work is published under https://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c244t-f4a39b671a938c791fa2aa54615c73be23478eaf53411f5e29b3be30a255b25e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38646244$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Harit, Mahesh Kumar</creatorcontrib><creatorcontrib>Mundhe, Narendra</creatorcontrib><creatorcontrib>Tamoli, Sr, Sanjay</creatorcontrib><creatorcontrib>Pawar, Vinay</creatorcontrib><creatorcontrib>Bhapkar, Vedvati</creatorcontrib><creatorcontrib>Kolhe, Ganesh</creatorcontrib><creatorcontrib>Mahadik, Swapnali</creatorcontrib><creatorcontrib>Kulkarni, Anand</creatorcontrib><creatorcontrib>Agarwal, Ankit</creatorcontrib><title>Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems</title><title>Curēus (Palo Alto, CA)</title><addtitle>Cureus</addtitle><description>Background and objectives SIVI is a standardized extract prepared using the aerial parts of
developed to enhance the quality of sleep. The objective of the present study was to the evaluate efficacy and safety of SIVI (
extract) in the management of stress and sleep problems in Indian participants in a randomized, double-blind, placebo-controlled, clinical study. Materials and methods A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI (
extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30. Results
extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI (
extract) group compared to the placebo group on day 15 and day 30. SIVI (
extract) did not show any adverse effects. Conclusions The results of the current study indicate that
extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia.</description><subject>Anxiety</subject><subject>Diabetes</subject><subject>Fatigue</subject><subject>Hypertension</subject><subject>Hypotheses</subject><subject>Insomnia</subject><subject>Sleep</subject><subject>Stress</subject><issn>2168-8184</issn><issn>2168-8184</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNpdkclP3DAUh62qVQcBt54rS730QMBrnBxhWhYJqSOg6jF68byoHjnx1E4OcOUfx7NQIU5v-96mHyFfODs1Rtdndoo4pVNdask-kAPBy6qoeKU-vvFn5DilFWOMMyOYYZ_JTFalKoVSB-T5DoZl6N0TLk_ojzC1HosL74YcLTxYbEMxD8MYg_cbYp5LzoKn9-O0fKShowtIyXU-RKBusBAHGDdezsfRWbeGYUz0jxv_5paIKdG8j957xDVdxJDX9emIfOrAJzze20Py-_Lnw_y6uP11dTM_vy1sPnUsOgWybkvDoZaVNTXvQABoVXJtjWxRSGUqhE5LxXmnUdRtzkoGQutWaJSH5Ptu7jqGfxOmseldsug9DBim1EimpDGVUDKj396hqzDl3_yWqk2tGK8zdbKjbAwpReyadXQ9xMeGs2ajT7PTp9nqk_Gv-6FT2-PyP_yqhnwB8N6Mig</recordid><startdate>20240320</startdate><enddate>20240320</enddate><creator>Harit, Mahesh Kumar</creator><creator>Mundhe, Narendra</creator><creator>Tamoli, Sr, Sanjay</creator><creator>Pawar, Vinay</creator><creator>Bhapkar, Vedvati</creator><creator>Kolhe, Ganesh</creator><creator>Mahadik, Swapnali</creator><creator>Kulkarni, Anand</creator><creator>Agarwal, Ankit</creator><general>Cureus Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20240320</creationdate><title>Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems</title><author>Harit, Mahesh Kumar ; Mundhe, Narendra ; Tamoli, Sr, Sanjay ; Pawar, Vinay ; Bhapkar, Vedvati ; Kolhe, Ganesh ; Mahadik, Swapnali ; Kulkarni, Anand ; Agarwal, Ankit</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c244t-f4a39b671a938c791fa2aa54615c73be23478eaf53411f5e29b3be30a255b25e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Anxiety</topic><topic>Diabetes</topic><topic>Fatigue</topic><topic>Hypertension</topic><topic>Hypotheses</topic><topic>Insomnia</topic><topic>Sleep</topic><topic>Stress</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Harit, Mahesh Kumar</creatorcontrib><creatorcontrib>Mundhe, Narendra</creatorcontrib><creatorcontrib>Tamoli, Sr, Sanjay</creatorcontrib><creatorcontrib>Pawar, Vinay</creatorcontrib><creatorcontrib>Bhapkar, Vedvati</creatorcontrib><creatorcontrib>Kolhe, Ganesh</creatorcontrib><creatorcontrib>Mahadik, Swapnali</creatorcontrib><creatorcontrib>Kulkarni, Anand</creatorcontrib><creatorcontrib>Agarwal, Ankit</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Curēus (Palo Alto, CA)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Harit, Mahesh Kumar</au><au>Mundhe, Narendra</au><au>Tamoli, Sr, Sanjay</au><au>Pawar, Vinay</au><au>Bhapkar, Vedvati</au><au>Kolhe, Ganesh</au><au>Mahadik, Swapnali</au><au>Kulkarni, Anand</au><au>Agarwal, Ankit</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems</atitle><jtitle>Curēus (Palo Alto, CA)</jtitle><addtitle>Cureus</addtitle><date>2024-03-20</date><risdate>2024</risdate><volume>16</volume><issue>3</issue><spage>e56530</spage><epage>e56530</epage><pages>e56530-e56530</pages><issn>2168-8184</issn><eissn>2168-8184</eissn><abstract>Background and objectives SIVI is a standardized extract prepared using the aerial parts of
developed to enhance the quality of sleep. The objective of the present study was to the evaluate efficacy and safety of SIVI (
extract) in the management of stress and sleep problems in Indian participants in a randomized, double-blind, placebo-controlled, clinical study. Materials and methods A total of 65 participants with stress and insomnia were randomized to two groups with 32 in the SIVI (
extract) group and 33 in the placebo group. Subjects were asked to take the test substance along with water at bedtime for 30 days. The Perceived Stress Scale, quality of life using the General Health Questionnaire (GHQ-12) scale, and Insomnia Severity Index were assessed on day 1, day 15, and day 30. Results
extract showed a statistically significant reduction in the mean score of stress on the Perceived Stress Scale and significantly increased the mean score of total sleep time compared to placebo. The general psychological health was found to be significantly improved in the SIVI (
extract) group compared to the placebo group on day 15 and day 30. SIVI (
extract) did not show any adverse effects. Conclusions The results of the current study indicate that
extract is beneficial in the management of stress and helps to improve sleep quality in subjects with stress and insomnia.</abstract><cop>United States</cop><pub>Cureus Inc</pub><pmid>38646244</pmid><doi>10.7759/cureus.56530</doi><oa>free_for_read</oa></addata></record> |
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| source | PubMed Central; PubMed Central Open Access |
| subjects | Anxiety Diabetes Fatigue Hypertension Hypotheses Insomnia Sleep Stress |
| title | Randomized, Double-Blind, Placebo-Controlled, Clinical Study of Passiflora incarnata in Participants With Stress and Sleep Problems |
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