@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 = {January 2025}, 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} }