A Randomized, Double Blind, Comparative, Multi-centric, Interventional, Prospective, Clinical study to Evaluate Efficacy & Safety of Topical head application Oil in participants with Stress & Insomnia

It is a randomized, double blind, comparative, multi-centric, interventional, prospective, clinical study to evaluate efficacy & safety of Topical head application Oil in participants with Stress and Insomnia. Study will be carried out in 3 to 4 centers in India. As per computer generated randomization list, participants will be randomized to one of the two study groups in 1:1 ratio. Participants will be asked to apply sufficient quantity of given oil on scalp in evening and thereafter head massage for 5 minutes for 14 days. Primary objectives of the study will be to assess change in stress level using perceived stress scale (PSS) and change in patient-reported total sleep time (as per Participant diary). Secondary objectives of the study will be to assess relaxation, cooling, refreshing, soothing (VAS) and time duration of relaxation, cooling, refreshing, soothing post application, change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset based on participant diary, change in fatigue using Fatigue Severity Scale (FSS), change in headache mood, ability to function at work, and concentration on a graded scale, change in severity of insomnia using Insomnia Severity Index (ISI), change in quality of sleep using Pittsburgh Sleep Quality Index (PSQI), change in hair fall through running finger test, comb test pull test and Dandruff test, change in quality of life (QOL) using Quality of Life Enjoyment and Satisfaction Questionnaire â€“ Short Form (Q-LES-Q-SF), changes in morning serum cortisol level, assessment of adverse events and vitals, global assessment for overall change by participants and by physician and post study tolerability of study product by participants and physician on day 0, day 7 and day 14.

Summary of Results:

The study concludes that topical use of DCO (DRDC/2024/009) for head message for a period of 14 days helps to reduce stress and fatigue and improve sleep onset, duration of sleep and sleep efficiency. DCO helped to impart relaxing, cooling (calming), refreshing and soothing effects, which was observed to be significantly better than control. The cooling (calming) refreshing and relaxation experience lasted for more than 8 hours. DCO also helped to reduce symptoms like headache and improve daytime mood, ability to function and concentration. Topical use of DCO to relieve the above symptoms was assessed to be safe.