A clinical trial to study the effect of Head Massage with NRCCO Oil in Patients Suffering from Mild to Moderate Anxiety and Stress

Phase 2

Completed

Conditions: Health Condition 1: null- Stress and Anxiety

Registration Number: CTRI/2012/05/002671

Lead Sponsor: Emami Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Subjects meeting all of the following criteria will be included to the trial-

1)Subjects suffering from mild to moderate anxiety (who achieve scores between 18 and 24 points on the Hamilton Scale for Anxiety)

2)Subject having age 20 to 65 years, both inclusive.

3)Subjects of female gender or a non-pregnant, non-lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.

4)Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

1)Subjects suffering from severe depression, schizophrenia, diabetes mellitus, heart disease, HIV/AIDS, kidney and liver diseases will not be recruited in the trial.

2)Subjects having addiction to any drug, including alcohol will not be recruited in the trial.

3)Subjects who are using any medication such as anxiolytic, anti-stress medication and under psychotherapy will not be recruited in the trial

4)Subjects on any other medications that could interfere with the effect of the drug under study will not be recruited in the study.

5)In addition, subject should have ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia.

6)Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

7)Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion,

8)Use of any other investigational drug within 1 month prior to randomization

9)Known hypersensitivity to ingredients used in study drug

10)Pregnant and Lactating females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline visit to week 4 in Hamilton Rating Scale for Anxiety (HAM-A) Total ScoreTimepoint: 28 days

Secondary Outcome Measures

Name	Time	Method
1.Mean change from baseline visit to week 4 in Global assessment for overall improvement assessment by the Investigator <br/ ><br> <br/ ><br> <br/ ><br>2.Mean change from baseline visit to week 4 in Global assessment for overall improvement assessment by the subject <br/ ><br> <br/ ><br>3.Mean change from baseline visit to week 4 in overall Quality Of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) <br/ ><br> <br/ ><br>4.Tolerability of study drugs by assessing the incidence of adverse events (AEs) and discontinuation due to the AEs <br/ ><br>Timepoint: 28 days