Proof of Efficacy Study to Evaluate an Ayurvedic Formulation in the Treatment of Allergic Rhinitis: An Open Label Randomized Controlled Clinical Trial
Background: Allergic rhinitis is largely treated by using antihistamines and nasal sprays, either alone or in combination. However, these measures ease out the symptoms but do not address causative factors, and have their share of side effects and limitations. An Ayurvedic herbo-mineral formulation,...
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| creator | Prakash, Vaidya B Rao, Yashwant K Prakash, Shikha Sati, Sneha T Mohapatra, Ankita Negi, Neha |
| description | Background: Allergic rhinitis is largely treated by using antihistamines and nasal sprays, either alone or in combination. However, these measures ease out the symptoms but do not address causative factors, and have their share of side effects and limitations. An Ayurvedic herbo-mineral formulation, IMMBO, has been reported to be effective in treating allergic rhinitis.Objective: The present study was carried out to evaluate the efficacy, safety, and tolerability of the Ayurvedic herbo-mineral formulation in comparison with a fixed-dose combination of levocetirizine and montelukast.Method: This was a randomized, comparative, clinical study carried out on 250 patients at a medical college in India. The patients were enrolled according to the eligibility criteria of the study and randomized into two groups, to receive either Ayurvedic herbo-mineral formulation, IMMBO, or a combination of levocetirizine and montelukast for 28 days. Total nasal symptom score (TNSS) and Immunoglobulin E (IgE) were calculated for evaluation of efficacy parameters. Result: At the end of therapy both IMMBO and levocetirizine and montelukast combination showed significant improvement in TNSS in both treated population and per protocol population. The IMMBO group had a statistically higher reduction in TNSSs compared to the levocetirizine + montelukast group (-5.70 vs. -3.31; p |
| doi_str_mv | 10.7759/cureus.46663 |
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| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10628601</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2895626682</sourcerecordid><originalsourceid>FETCH-LOGICAL-c320t-9e14c9ae866e9d9dffc654c055d206af53ebdb7508493972f9c099d268b4bd23</originalsourceid><addsrcrecordid>eNpdkd-KEzEUhwdRcKl75wMEvPHCrpnMTCbxRkrpqlBYWXsfMsnJNksmqflTqA_i85raRVQI5EC-fOccfk3zusU34zjw96pEKOmmp5R2z5or0lK2ZC3rn_9Vv2yuU3rEGLd4JHjEV83PrzEEg-rZGGOVVCf0LRd9QjmgzVG6IjMg6dHqVOIRtFXoNsS5OJlt8Mh6lPeAdhFknsHns2flHMSHCt7vrbfZpg9o5dHdATzaygkcupdeh9n-AI3WwecY6odaukor6arMSveqeWGkS3D9dC-a3e1mt_683N59-rJebZeqIzgvObS94hIYpcA118YoOvQKD4MmmEozdDDpaRww63nHR2K4wpxrQtnUT5p0i-bjRXso0wxa1RWidOIQ7SzjSQRpxb8v3u7FQziKFlPCKG6r4e2TIYbvBVIWs00KnJMeQkmCMMZw15Paf9G8-Q99DCX6ul6l-EAJpew80rsLpWJIKYL5M02LxTlocQla_A66-wWFN59h</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2895626682</pqid></control><display><type>article</type><title>Proof of Efficacy Study to Evaluate an Ayurvedic Formulation in the Treatment of Allergic Rhinitis: An Open Label Randomized Controlled Clinical Trial</title><source>PubMed Central Open Access</source><source>PubMed Central</source><creator>Prakash, Vaidya B ; Rao, Yashwant K ; Prakash, Shikha ; Sati, Sneha T ; Mohapatra, Ankita ; Negi, Neha</creator><creatorcontrib>Prakash, Vaidya B ; Rao, Yashwant K ; Prakash, Shikha ; Sati, Sneha T ; Mohapatra, Ankita ; Negi, Neha</creatorcontrib><description>Background: Allergic rhinitis is largely treated by using antihistamines and nasal sprays, either alone or in combination. However, these measures ease out the symptoms but do not address causative factors, and have their share of side effects and limitations. An Ayurvedic herbo-mineral formulation, IMMBO, has been reported to be effective in treating allergic rhinitis.Objective: The present study was carried out to evaluate the efficacy, safety, and tolerability of the Ayurvedic herbo-mineral formulation in comparison with a fixed-dose combination of levocetirizine and montelukast.Method: This was a randomized, comparative, clinical study carried out on 250 patients at a medical college in India. The patients were enrolled according to the eligibility criteria of the study and randomized into two groups, to receive either Ayurvedic herbo-mineral formulation, IMMBO, or a combination of levocetirizine and montelukast for 28 days. Total nasal symptom score (TNSS) and Immunoglobulin E (IgE) were calculated for evaluation of efficacy parameters. Result: At the end of therapy both IMMBO and levocetirizine and montelukast combination showed significant improvement in TNSS in both treated population and per protocol population. The IMMBO group had a statistically higher reduction in TNSSs compared to the levocetirizine + montelukast group (-5.70 vs. -3.31; p<0.01). There was a statistically significant difference in the reduction of IgE levels between the groups (-351.54 vs. -208.79; p<0.05). Conclusion: The findings of this study establish prima facie evidence about the efficacy and safety of Ayurvedic formulation. However, the said Ayurvedic formulation needs to be further developed scientifically.</description><identifier>ISSN: 2168-8184</identifier><identifier>EISSN: 2168-8184</identifier><identifier>DOI: 10.7759/cureus.46663</identifier><language>eng</language><publisher>Palo Alto: Cureus Inc</publisher><subject>16th century ; 8th century ; Allergies ; Allergy/Immunology ; Asthma ; Ayurvedic medicine ; Clinical significance ; Clinical trials ; Disease ; Drug dosages ; Hay fever ; Integrative/Complementary Medicine ; Nose ; Patients ; Rhinitis ; Sinusitis ; Steroids</subject><ispartof>Curēus (Palo Alto, CA), 2023-10, Vol.15 (10), p.e46663-e46663</ispartof><rights>Copyright © 2023, Prakash et al. This work is published under https://creativecommons.org/licenses/by/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright © 2023, Prakash et al. 2023 Prakash et al.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c320t-9e14c9ae866e9d9dffc654c055d206af53ebdb7508493972f9c099d268b4bd23</citedby><cites>FETCH-LOGICAL-c320t-9e14c9ae866e9d9dffc654c055d206af53ebdb7508493972f9c099d268b4bd23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628601/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10628601/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,886,27929,27930,53796,53798</link.rule.ids></links><search><creatorcontrib>Prakash, Vaidya B</creatorcontrib><creatorcontrib>Rao, Yashwant K</creatorcontrib><creatorcontrib>Prakash, Shikha</creatorcontrib><creatorcontrib>Sati, Sneha T</creatorcontrib><creatorcontrib>Mohapatra, Ankita</creatorcontrib><creatorcontrib>Negi, Neha</creatorcontrib><title>Proof of Efficacy Study to Evaluate an Ayurvedic Formulation in the Treatment of Allergic Rhinitis: An Open Label Randomized Controlled Clinical Trial</title><title>Curēus (Palo Alto, CA)</title><description>Background: Allergic rhinitis is largely treated by using antihistamines and nasal sprays, either alone or in combination. However, these measures ease out the symptoms but do not address causative factors, and have their share of side effects and limitations. An Ayurvedic herbo-mineral formulation, IMMBO, has been reported to be effective in treating allergic rhinitis.Objective: The present study was carried out to evaluate the efficacy, safety, and tolerability of the Ayurvedic herbo-mineral formulation in comparison with a fixed-dose combination of levocetirizine and montelukast.Method: This was a randomized, comparative, clinical study carried out on 250 patients at a medical college in India. The patients were enrolled according to the eligibility criteria of the study and randomized into two groups, to receive either Ayurvedic herbo-mineral formulation, IMMBO, or a combination of levocetirizine and montelukast for 28 days. Total nasal symptom score (TNSS) and Immunoglobulin E (IgE) were calculated for evaluation of efficacy parameters. Result: At the end of therapy both IMMBO and levocetirizine and montelukast combination showed significant improvement in TNSS in both treated population and per protocol population. The IMMBO group had a statistically higher reduction in TNSSs compared to the levocetirizine + montelukast group (-5.70 vs. -3.31; p<0.01). There was a statistically significant difference in the reduction of IgE levels between the groups (-351.54 vs. -208.79; p<0.05). Conclusion: The findings of this study establish prima facie evidence about the efficacy and safety of Ayurvedic formulation. However, the said Ayurvedic formulation needs to be further developed scientifically.</description><subject>16th century</subject><subject>8th century</subject><subject>Allergies</subject><subject>Allergy/Immunology</subject><subject>Asthma</subject><subject>Ayurvedic medicine</subject><subject>Clinical significance</subject><subject>Clinical trials</subject><subject>Disease</subject><subject>Drug dosages</subject><subject>Hay fever</subject><subject>Integrative/Complementary Medicine</subject><subject>Nose</subject><subject>Patients</subject><subject>Rhinitis</subject><subject>Sinusitis</subject><subject>Steroids</subject><issn>2168-8184</issn><issn>2168-8184</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNpdkd-KEzEUhwdRcKl75wMEvPHCrpnMTCbxRkrpqlBYWXsfMsnJNksmqflTqA_i85raRVQI5EC-fOccfk3zusU34zjw96pEKOmmp5R2z5or0lK2ZC3rn_9Vv2yuU3rEGLd4JHjEV83PrzEEg-rZGGOVVCf0LRd9QjmgzVG6IjMg6dHqVOIRtFXoNsS5OJlt8Mh6lPeAdhFknsHns2flHMSHCt7vrbfZpg9o5dHdATzaygkcupdeh9n-AI3WwecY6odaukor6arMSveqeWGkS3D9dC-a3e1mt_683N59-rJebZeqIzgvObS94hIYpcA118YoOvQKD4MmmEozdDDpaRww63nHR2K4wpxrQtnUT5p0i-bjRXso0wxa1RWidOIQ7SzjSQRpxb8v3u7FQziKFlPCKG6r4e2TIYbvBVIWs00KnJMeQkmCMMZw15Paf9G8-Q99DCX6ul6l-EAJpew80rsLpWJIKYL5M02LxTlocQla_A66-wWFN59h</recordid><startdate>20231008</startdate><enddate>20231008</enddate><creator>Prakash, Vaidya B</creator><creator>Rao, Yashwant K</creator><creator>Prakash, Shikha</creator><creator>Sati, Sneha T</creator><creator>Mohapatra, Ankita</creator><creator>Negi, Neha</creator><general>Cureus Inc</general><general>Cureus</general><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><scope>5PM</scope></search><sort><creationdate>20231008</creationdate><title>Proof of Efficacy Study to Evaluate an Ayurvedic Formulation in the Treatment of Allergic Rhinitis: An Open Label Randomized Controlled Clinical Trial</title><author>Prakash, Vaidya B ; Rao, Yashwant K ; Prakash, Shikha ; Sati, Sneha T ; Mohapatra, Ankita ; Negi, Neha</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c320t-9e14c9ae866e9d9dffc654c055d206af53ebdb7508493972f9c099d268b4bd23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>16th century</topic><topic>8th century</topic><topic>Allergies</topic><topic>Allergy/Immunology</topic><topic>Asthma</topic><topic>Ayurvedic medicine</topic><topic>Clinical significance</topic><topic>Clinical trials</topic><topic>Disease</topic><topic>Drug dosages</topic><topic>Hay fever</topic><topic>Integrative/Complementary Medicine</topic><topic>Nose</topic><topic>Patients</topic><topic>Rhinitis</topic><topic>Sinusitis</topic><topic>Steroids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Prakash, Vaidya B</creatorcontrib><creatorcontrib>Rao, Yashwant K</creatorcontrib><creatorcontrib>Prakash, Shikha</creatorcontrib><creatorcontrib>Sati, Sneha T</creatorcontrib><creatorcontrib>Mohapatra, Ankita</creatorcontrib><creatorcontrib>Negi, Neha</creatorcontrib><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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Curēus (Palo Alto, CA)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Prakash, Vaidya B</au><au>Rao, Yashwant K</au><au>Prakash, Shikha</au><au>Sati, Sneha T</au><au>Mohapatra, Ankita</au><au>Negi, Neha</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Proof of Efficacy Study to Evaluate an Ayurvedic Formulation in the Treatment of Allergic Rhinitis: An Open Label Randomized Controlled Clinical Trial</atitle><jtitle>Curēus (Palo Alto, CA)</jtitle><date>2023-10-08</date><risdate>2023</risdate><volume>15</volume><issue>10</issue><spage>e46663</spage><epage>e46663</epage><pages>e46663-e46663</pages><issn>2168-8184</issn><eissn>2168-8184</eissn><abstract>Background: Allergic rhinitis is largely treated by using antihistamines and nasal sprays, either alone or in combination. However, these measures ease out the symptoms but do not address causative factors, and have their share of side effects and limitations. An Ayurvedic herbo-mineral formulation, IMMBO, has been reported to be effective in treating allergic rhinitis.Objective: The present study was carried out to evaluate the efficacy, safety, and tolerability of the Ayurvedic herbo-mineral formulation in comparison with a fixed-dose combination of levocetirizine and montelukast.Method: This was a randomized, comparative, clinical study carried out on 250 patients at a medical college in India. The patients were enrolled according to the eligibility criteria of the study and randomized into two groups, to receive either Ayurvedic herbo-mineral formulation, IMMBO, or a combination of levocetirizine and montelukast for 28 days. Total nasal symptom score (TNSS) and Immunoglobulin E (IgE) were calculated for evaluation of efficacy parameters. Result: At the end of therapy both IMMBO and levocetirizine and montelukast combination showed significant improvement in TNSS in both treated population and per protocol population. The IMMBO group had a statistically higher reduction in TNSSs compared to the levocetirizine + montelukast group (-5.70 vs. -3.31; p<0.01). There was a statistically significant difference in the reduction of IgE levels between the groups (-351.54 vs. -208.79; p<0.05). Conclusion: The findings of this study establish prima facie evidence about the efficacy and safety of Ayurvedic formulation. However, the said Ayurvedic formulation needs to be further developed scientifically.</abstract><cop>Palo Alto</cop><pub>Cureus Inc</pub><doi>10.7759/cureus.46663</doi><oa>free_for_read</oa></addata></record> |
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| subjects | 16th century 8th century Allergies Allergy/Immunology Asthma Ayurvedic medicine Clinical significance Clinical trials Disease Drug dosages Hay fever Integrative/Complementary Medicine Nose Patients Rhinitis Sinusitis Steroids |
| title | Proof of Efficacy Study to Evaluate an Ayurvedic Formulation in the Treatment of Allergic Rhinitis: An Open Label Randomized Controlled Clinical Trial |
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