@article {2416, title = {A Double-blind, Randomized Controlled Study of Triterpenoids based Standardized Gotu Kola Leaves Extract in the Patients with Tension Type Headache}, journal = {Pharmacognosy Journal}, volume = {16}, year = {2024}, month = {December 2024}, pages = {1238-1251}, type = {Original Article}, chapter = {1238}, abstract = {

Introduction: Triterpenoid-based standardized Centella asiatica leaves extract as nasal solution (INDCANS) has shown potential in animal models of stress-related disorders. Objective: Efficacy and safety evaluation of INDCA-NS in patients with Tension-type headache (TTH). Methods: 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 {\textquotedblleft}Depression, Anxiety, and Stress Scale{\textquotedblright} (DASS-21); {\textquotedblleft}Work Productivity and Activity Questionnaire{\textquotedblright} (WPAI: SHP); {\textquotedblleft}World Health Organization Brief{\textquotedblright} (WHOQOL-BREF), cortisol and DHEA levels, rescue medications), and safety outcome measures (including adverse events) were monitored. Results: Subacute administration of INDCA-NS (but not PLACEBOCA-NS) significantly reduced the duration of headache and TTH{\textquoteright}s effect of TTH on WPAI:SHP (Q5) scores, namely productivity in working patients (P \< 0.05, within the groups). The INDCA-NS showed significant difference (P \< 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{\textquoteright}s impact on daily activities (Q6 of WPAI:SHP), and improved WHOQOL scores (P \< 0.05, within the group). The other outcome measures were not statistically significant within or between groups. Conclusion: Subacute INDCA-NS reduced headache duration and improved work productivity in TTH patients.

}, keywords = {Centella asiatica leaves; Chronic Stress; Pain; Work productivity}, doi = {10.5530/pj.2024.16.202}, author = {Prasad Thakurdesai and Pallavi Deshpande and Namrata Desai and Prasanna Mathad and Sandhya Rani and Dhananjay Raje} } @article {1725, title = {Preclinical Safety Evaluation of Acute and Subacute Intranasal Administration of Polyphenols-based Cinnamon Bark Extract in Laboratory Rats}, journal = {Pharmacognosy Journal}, volume = {13}, year = {2021}, month = {December 2021}, pages = {1621-1631}, type = {Original Article}, chapter = {1621}, abstract = {

Background: Polyphenols-based standardized cinnamon (Cinnamomum zeylanicum) bark extract (IND02) demonstrated efficacy against allergic rhinitis in animal models and human clinical study. Objectives: To assess the acute and subacute intranasal toxicity of the IND02 nasal solution (IND02-NS). Methods: 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. Results: 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. Conclusion: IND02-NS was found safe at 100 μg/rat/day during acute and subacute (28 days repeated dose) for nasal administration in rats.

}, keywords = {Intranasal toxicity, Maximum tolerated dose, Noobserved- adverse-effect level., Polyphenols, Standardized cinnamon bark}, doi = {10.5530/pj.2021.13.209}, author = {Prasad Thakurdesai and Pallavi Deshpande} }