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Sleeplessness treated with lifestyle modification and regimenal therapy

Efficacy of Natul therapy with herbal decoction Vs placebo control in the Management of sahar lazim primary insomnia A Randomized Comparative controlled clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100178
Enrollment
72
Registered
2026-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Intervention1: Natul therapy: Approximately 1 litre of herbal decoction made of jao babuna and ukhwahan poured in rhythmic flow over the forehead for 10 to 15 mins Control Intervention1: Natul therapy

Sponsors

Aiysha Farhana K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ISI Score more than 21 criterion for enrolment is more than 30 mins to fall asleep and subjective total sleep time less than 6.5 hrs per night for atleast 3 nights per week and daytime complaints associated with disturbed sleep the disturbance does not occur exclusively during the course of another mental disorder

Exclusion criteria

Exclusion criteria: participants below 18 and above 60 years of age will be excluded ISI less than 21 Psychiatric illness Mental disorders(e.g.Major Depressive Disorder, Generalized Anxiety Disorder,a Delirium) Physiological effects of a substance (e.g.a drug abuse,a medication) or a general medical condition Pregnancy and Lactation Mentally retarded patients

Design outcomes

Primary

MeasureTime frame
To access the improvement in sleep quality using Insomnia Severity Index(ISI) To compare the outcomes between Natul group and Control groupTimepoint: baseline and 14th day

Secondary

MeasureTime frame
To evaluate the impact of natul therapy on health related quality of life using SF36v2 to assess daytime sleepiness and functional fatigue using epsworth sleepiness scale to quantify energy expenditure and physical activity during functional tasks using samrtphone compatible digital tools and wearablesTimepoint: baseline and 14th day

Countries

India

Contacts

Public ContactDr Nizamudeen S

Tamilnadu Dr MGR Medical University

drnizamgumc@gamil.com8754404152

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026