An Open Labeled, Prospective, Clinical Study to Evaluate Efficacy and Safety of Head Massage with NRCCO OIL in Patients Suffering from Mild to Moderate Anxiety and Stress

Subjects suffering from anxiety and stress, attending outpatient clinic at R. A. Podar Hospital, Worli, Mumbai-18 will be screened for eligibility criteria. Considering 20% dropout rate, 36 subjects will be recruited in the trial to get 30 evaluable cases. On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and his/her physical examinations will be done.  Subject will be assessed for severity of Anxiety on Hamilton Anxiety Rating Scale (HAM-A). If Subject’s score is between 18 and 24 points on HAM-A, then subject will be considered eligible for recruitment.

 On baseline visit, subject will be recruited in the study if he/she meets all the inclusion criteria. Subject will be asked to come to hospital for follow up on every week after baseline visit till the completion of the study (Week 4). At baseline visit and at every follow up visit (except last follow up visit), subjects will be given 2 bottles each containing 150 ml of NRCCO Oil (210 ml for 7 days and 90 ml for use if follow up is delayed maximum by 3 days). Subjects will be advised to apply sufficient quantity of NRCCO Oil on scalp and thereafter head massage for 10 minutes. Subjects will be instructed to use NRCCO Oil for head massage two times daily i.e in the morning (30 minutes before bath) and in the evening (30 minutes before bedtime) .

 On every follow up visit, subjects will undergo general and systemic examinations and assessment of severity of anxiety on HAM-A scale. Subject’s global evaluation for overall improvement and Investigator’s global evaluation for overall improvement will be done on every follow–up visit till the completion of the study. Tolerability of the trial drug will be assessed by the investigator and by the patient at the end of the trial. All the subjects will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. 

Summary of Results:

The present study on NRCCO concludes that head massage with NRCCO helps significantly in reducing the symptoms of stress and anxiety as measured on HAMA scale. The common symptoms of stress and anxiety like insomnia, tension, fear, depressed mood, headache were relieved significantly by regular head massage with NRCCO for 28 days. A significant reduction in the symptoms was observed with 7 days of head massage with oil. The improvement in symptoms continued and at the end of the trial i.e. 28 days. It can thus be concluded that head massage with NRCCO can prove to be a useful remedy in the management of stress and anxiety.