Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Shirodhara: The active treatment will be Shirodhara with Ksheerbala oil for 7 sessions. The 7 sessions can be completed in 10 days. (7 sessions ± 3 days). The subjects of control group
Sponsors
Centre for Integrative Medicine and Research CIMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with Chronic Insomnia Disorder based on ICSD-3 Criteria at the time of screening at Department of psychiatry, AIIMS, Delhi. 2. Habitual bedtime between 9:00 pm and midnight. 3. Able and willing to follow all study related instructions and to make all required visits. 4. Insomnia severity index score between 15-21.
Exclusion criteria
Exclusion criteria: 1.Shirodhara therapy related: a)Patients with known allergy to oil formulations / massage. b)Any injury over head / neck, presence of an open wound / abrasion on over forehead & scalp region. c)Central / peripheral neuropathy. d)Patients having problems in lying supine for 1 hour. e)Patients who cannot be relied upon to comply with the therapy procedures or are unwilling to give informed consent. 2.Patients with substance abuse (excluding tobacco, alcohol), severe depressive, psychotic or bipolar disorder with significant suicide risk. 3.Patient diagnosed other primary sleep disorders (OSA, RLS and circadian rhythm sleep disorders etc) will be excluded from study. 4.Patients having sleep schedule changes associated with shift work or night shifts in previous 7 days before study initiation or who intend to do the same during the study period. 5.Patients with clinically significant uncontrolled endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness. 6.Patients with history of malignancy, seizures or significant head trauma. 7.Pregnant or lactating women. 8.Patients in whom another investigational drug was used within three months prior to entry in this study. 9.Subjects otherwise judged by investigator or co- investigator to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. By use of Actigraph-Time to sleep onset,Wake time after sleep onset,Sleep Efficiency,Total sleep time, Nocturnal awakenings after sleep onset (NE) 2.Insomnia Severity index (ISI) 3.Epworth Sleepiness Scale (ESS) 4.Pittsburgh Sleep Quality Index (PSQI) 5.Sleep Diary assessmentTimepoint: For Shirodhara group- At Baseline, after 7 sessions and (i.e. 7 ±3 days), 7 days after intervention. for control group - Baseline, After 10 days and 17 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression Anxiety Stress Scale 2. Salivary cortisol 3. Improvement in symptoms of insomnia & manasa bhava pariksha as per Ayurveda 4. Respiratory rate (RR), Pulse rate (PR) Blood pressure (BP) 5. Visual analogue scale (V.A.S) for StressTimepoint: For Shirodhara group- At Baseline, after 7 sessions and (i.e. 7 ±3 days), 7 days after intervention. for control group - Baseline, After 10 days and 17 days | — |
Countries
India
Contacts
Public ContactDr Gautam Sharma
All India Institute of Medical Sciences (AIIMS)
Outcome results
None listed