Study to assess the effect of nasya karma in brain through f-MRI

Phase 3

Lead Sponsor: Central Council for Research in Ayurveda Sciences Ministry of Ayush New Delhi

Recruitment & Eligibility

Inclusion Criteria

1 Healthy volunteers

2 Willing to participate and give written informed consent

3 Physically independent, ambulatory volunteers

4 Right-handed

5 Willing to abstain from beverages such as coffee, tea, energy drinks or other such stimulants beginning 12 hours prior to fMRI

6 BMI of 17.5 to 30.5 kg/m2

Exclusion Criteria

1 Presence of any illness or disease symptom as elicited by detailed clinical response, history and laboratory investigations

2 history of psychiatric disorders, as assessed by Mini international neuropsychiatric interview, or psycho-somatic disorders

NasyaAnarha

3 history of psychiatric disorders, as assessed by Mini international neuropsychiatric interview, or psycho-somatic disorders

4 use of psychotropic medication known to interfere with the dopaminergic system or sedatives in the last six months

5 Family history of psychiatric diseases

6 Past or current abuse of psychoactive drugs, alcohol use and smoking

7 Contraindicated for MRI

8 Participants who have cognitive impairment

9 Women in menstrual or ovulatory phase

10 Intracranial abnormalities that can adversely affect the interpretation of the brain scans

11 Self-identifies as claustrophobic.

Primary Outcome Measures

Name	Time	Method
â?¢To map brain neuro-physiological activity in response to Nasya through BOLD FMRI <br/ ><br>â?¢To explore brain hemodynamic response, such as alterations in blood flow, blood volume, and intravascular magnetic susceptibility, to Nasya Karma <br/ ><br>â?¢To study the effect of Marsa nasya procedure in apparently healthy volunteers in quality of life, cognitive, sleep and psychological domains. <br/ ><br>Timepoint: Time points for f-MRI - Before Treatment, within 15 minutes of nasya karma, 14th day <br/ ><br>Time points of questionnaire assessment - before treatment, 14th day, 30th day

Secondary Outcome Measures

Name	Time	Method
1. Effect of Marsa nasya in Montreal Cognitive Assessment Scale (MocA) in apparently healthy volunteers <br/ ><br>2. Effect of Marsa nasya in Perceived Stress Scale in apparently healthy volunteers <br/ ><br>3. Effect of Marsa nasya in Hamilton Anxiety Scale in apparently healthy volunteers <br/ ><br>4. Effect of Marsa nasya in Pittsburg Sleep Quality Index in apparently healthy volunteers <br/ ><br>5. Effect of Marsa nasya in SF36 Quality of Life Questionnaire in apparently healthy volunteers <br/ ><br>Timepoint: 0th day, 15th day, 30th day