Managing Insomnia with Sesame Oil Ear Therapy and Foot Massage: A Clinical Study

Pragmatic Exploration of Nidranasha and its management with Karna Purana and Padabhyanga with Tila Taila - A Controlled Clinical Study - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112781

Enrollment

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G470- Insomnia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Participants diagnosed with Chronic Insomnia Disorder as per ICD-11 criteria (Code: 7A00), with disturbed sleep for more than 3 months and less than one year. Participants complaining of reduction in sleep time, difficulty in initiating or maintaining of sleep. Participants between the age group of 40 to 60 years. Participants eligible for Karna purana and Padabhyanga Participants having the controlled Blood Pressure and Blood Sugar. Participants having one or more daytime symptoms such as fatigue, depressed mood or irritability, general malaise, cognitive impairment.

Exclusion criteria

Exclusion criteria: Nidranasha because of another sleep-wake disorder, a mental disorder (schizophrenia, depressive psychosis, epilepsy etc.), another medical condition, or a substance or medication. Participants not eligible for Karna purana and Padabhyanga. Participants who are having shifting duties. Participants with drug dependency. Participants with acute illness like cardiovascular accidents, myocardial infarction and chronic obstructive pulmonary diseases. Participants having disturbed sleep for less than three months.

Design outcomes

Primary

Measure	Time frame
Total Sleep Time (TST) measured by ActigraphyTimepoint: Baseline (7-day pre-intervention average), Mid-intervention (Day 11), End of intervention (Day 21)	—

Secondary

Measure	Time frame
1.Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), and Sleep Efficiency measured by actigraphy. 2.Pittsburgh Sleep Quality Index (PSQI) score 3.Perceived Stress Scale (PSS) score 4.Serum Cortisol levelTimepoint: 1.Baseline (7-day pre-intervention average), Mid-intervention (Day 11), End of intervention (Day 21) 2.Day 0 and Day 21 3.Day 0, Day 11, Day 21 4.Day 0 and Day 21	—

Countries

India

Contacts

Public ContactProf H A Vyas

Institute of Teaching and Research in Ayurveda (ITRA)

hiteshayu@gmail.com9426433231

Outcome results