<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Prasad Thakurdesai</style></author><author><style face="normal" font="default" size="100%">Pallavi Deshpande</style></author><author><style face="normal" font="default" size="100%">Namrata Desai</style></author><author><style face="normal" font="default" size="100%">Prasanna Mathad</style></author><author><style face="normal" font="default" size="100%">Sandhya Rani</style></author><author><style face="normal" font="default" size="100%">Dhananjay Raje</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">A Double-blind, Randomized Controlled Study of Triterpenoids based Standardized Gotu Kola Leaves Extract in the Patients with Tension Type Headache</style></title><secondary-title><style face="normal" font="default" size="100%">Pharmacognosy Journal</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Centella asiatica leaves; Chronic Stress; Pain; Work productivity</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2024</style></year><pub-dates><date><style  face="normal" font="default" size="100%">December 2024</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">16</style></volume><pages><style face="normal" font="default" size="100%">1238-1251</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p class=&quot;rtejustify&quot;&gt;&lt;strong&gt;Introduction:&lt;/strong&gt; Triterpenoid-based standardized &lt;em&gt;Centella asiatica&lt;/em&gt; leaves extract as nasal solution (INDCANS) has shown potential in animal models of stress-related disorders. &lt;strong&gt;Objective:&lt;/strong&gt; Efficacy and safety evaluation of INDCA-NS in patients with Tension-type headache (TTH). &lt;strong&gt;Methods: &lt;/strong&gt;Ninety-one patients with TTH were randomized and administered INDCA-NS (46 patients) or PLACEBOCA-NS (45 patients) nasal spray (400 μg/day, 100 μg in 100 μL shot/ nostril, twice daily) for 28 days, with a 14-day follow-up. Efficacy (headache duration, frequency, and intensity; 21-item “Depression, Anxiety, and Stress Scale” (DASS-21); “Work Productivity and Activity Questionnaire” (WPAI: SHP); “World Health Organization Brief” (WHOQOL-BREF), cortisol and DHEA levels, rescue medications), and safety outcome measures (including adverse events) were monitored.&lt;strong&gt; Results: &lt;/strong&gt;Subacute administration of INDCA-NS (but not PLACEBOCA-NS) significantly reduced the duration of headache and TTH's effect of TTH on WPAI:SHP (Q5) scores, namely productivity in working patients (P &amp;lt; 0.05, within the groups). The INDCA-NS showed significant difference (P &amp;lt; 0.05) in headache duration with and without covariate adjustment (vs. PLACEBOCA-NS). Both treatments found safe, well- tolerated, with no treatment-related adverse events, significantly reduced headache frequency, pain intensity, DASS-21 (stress domain), TTH's impact on daily activities (Q6 of WPAI:SHP), and improved WHOQOL scores (P &amp;lt; 0.05, within the group). The other outcome measures were not statistically significant within or between groups. &lt;strong&gt;Conclusion: &lt;/strong&gt;Subacute INDCA-NS reduced headache duration and improved work productivity in TTH patients.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">6</style></issue><work-type><style face="normal" font="default" size="100%">Original Article</style></work-type><section><style face="normal" font="default" size="100%">1238</style></section><auth-address><style face="normal" font="default" size="100%">&lt;p class=&quot;rtejustify&quot;&gt;&lt;strong&gt;Prasad Thakurdesai*, Pallavi Deshpande, Namrata Desai, Prasanna Mathad , Sandhya Rani, Dhananjay Raje&lt;/strong&gt;&lt;/p&gt;

&lt;p class=&quot;rtejustify&quot;&gt;Department of Pharmacology, Poona College of Pharmacy, Bharati Vidyapeeth Deemed University, Pune, INDIA.&lt;/p&gt;
</style></auth-address></record><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Prasad Thakurdesai</style></author><author><style face="normal" font="default" size="100%">Pallavi Deshpande</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Preclinical Safety Evaluation of Acute and Subacute Intranasal Administration of Polyphenols-based Cinnamon Bark Extract in Laboratory Rats</style></title><secondary-title><style face="normal" font="default" size="100%">Pharmacognosy Journal</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">Intranasal toxicity</style></keyword><keyword><style  face="normal" font="default" size="100%">Maximum tolerated dose</style></keyword><keyword><style  face="normal" font="default" size="100%">Noobserved- adverse-effect level.</style></keyword><keyword><style  face="normal" font="default" size="100%">Polyphenols</style></keyword><keyword><style  face="normal" font="default" size="100%">Standardized cinnamon bark</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2021</style></year><pub-dates><date><style  face="normal" font="default" size="100%">December 2021</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">13</style></volume><pages><style face="normal" font="default" size="100%">1621-1631</style></pages><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p class=&quot;rtejustify&quot;&gt;&lt;strong&gt;Background: &lt;/strong&gt;Polyphenols-based standardized cinnamon (Cinnamomum zeylanicum) bark extract (IND02) demonstrated efficacy against allergic rhinitis in animal models and human clinical study. &lt;strong&gt;Objectives:&lt;/strong&gt; To assess the acute and subacute intranasal toxicity of the IND02 nasal solution (IND02-NS). &lt;strong&gt;Methods:&lt;/strong&gt; Acute and 28-days subacute toxicity using the intranasal route of administration of IND02-NS was evaluated using Wistar rats as per Organisation for Economic Co-operation and Development guidelines. For acute intranasal toxicity study, a single dose of 100 μg/rat/day was administered in five male and female rats and observed for the incidence of mortality and signs of toxicity for 14 days. For a 28-days subacute intranasal toxicity study, doses of 20, 50, and 100 μg/rat/day were administered to a group of five male and female rats.&lt;strong&gt; Results: &lt;/strong&gt;The IND02-NS did not show mortality or treatment-related adverse signs during acute (limit dose of 100 μg/rat/day) and subacute intranasal (28-days repeated dose of 20, 50, and 100 μg/rat/day with 14 days of reversal period) administration. The IND02-NS showed a maximum tolerated dose greater than 100 μg/rat during the acute intranasal toxicity study. The no-observed adverse effect level of IND02-NS was 100 μg/rat/day in rats during the subacute intranasal toxicity study. &lt;strong&gt;Conclusion:&lt;/strong&gt; IND02-NS was found safe at 100 μg/rat/day during acute and subacute (28 days repeated dose) for nasal administration in rats.&lt;/p&gt;
</style></abstract><issue><style face="normal" font="default" size="100%">6s</style></issue><work-type><style face="normal" font="default" size="100%">Original Article</style></work-type><section><style face="normal" font="default" size="100%">1621</style></section><auth-address><style face="normal" font="default" size="100%">&lt;p class=&quot;rtejustify&quot;&gt;&lt;strong&gt;Prasad Thakurdesai&lt;sup&gt;1&lt;/sup&gt;, Pallavi Deshpande&lt;sup&gt;1&lt;/sup&gt;,*&lt;/strong&gt;&lt;/p&gt;

&lt;p class=&quot;rtejustify&quot;&gt;&lt;sup&gt;1&lt;/sup&gt;Department of Scientific Affairs, Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, INDIA.&lt;/p&gt;
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