Article: A DOUBLE-BLIND RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE ANXIOLYTIC AND SEDATIVE EFFECT OF PARIJATA PUSHPA ARKA IN PREOPERATIVE PATIENTS

Article Category: Original Research articles

DOI: 10.7897/2277-4343.17253

Pages: 67-70

Author: Bhagya Shaji *, Rakesh RN

Abstract: Preoperative anxiety is a common issue that can negatively impact the perioperative period. It can increase the need for anesthesia, cause heart problems, delay recovery after surgery, and worsen pain afterward. Ayurveda offers several herbal mixes that have calming properties. Parijata Pushpa Arka, made from the flowers of Nyctanthes arbor-tristis, is believed to have calming and sedative effects, but scientific proof of these claims is still lacking. This study aimed to assess the anxiolytic and sedative effects of Parijata Pushpa Arka in patients undergoing elective surgery using objective measures. The study is carried out as per international conference of Harmonization-Good Clinical Practices Guidelines (ICH-GCP) or as per ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. We conducted a double-blind, randomized, placebo-controlled clinical study involving forty patients scheduled for elective surgeries. The participants were randomly divided into two groups. Group A received Parijata Pushpa Arka at ten milliliters twice daily for seven days before the surgery. Group B received distilled water as a placebo. We assessed anxiety levels using the State Trait Anxiety Inventory and the Amsterdam Preoperative Anxiety and Information Scale. We evaluated sedation levels with the Richmond Agitation Sedation Scale. We also recorded vital signs, including pulse rate and mean arterial pressure. We used Jamovi computer software for statistical analysis. The baseline demographic characteristics were similar in both groups. No significant differences were found between Group A and Group B regarding anxiety or sedation scores at any assessment point, with p-values greater than 0.05. The vital signs remained stable and comparable throughout the study. The study concluded that Parijata Pushpa Arka was safe and well-tolerated.

Keyword: Parijata Pushpa Arka, Preoperative anxiety, STAI, APAIS, RASS