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Ayurvedic managment in the Treatment of Insomnia.

A randomised controlled clinical trial between clonazepam, ayurvedic polyherbal formulation, and shirodhara in the management of anidra (insomnia) - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101546
Enrollment
90
Registered
2026-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: F519- Sleep disorder not due to a substance or known physiological condition, unspecified

Interventions

None listed

Sponsors

Government of West Bengal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 to 60 years.. 2. Diagnosed cases of Anidra (primary & secondary insomnia) based on Ayurvedic and modern criteria. 3. Patients with Insomnia Severity Index (ISI) score between mild to moderate (8-21). 4. Duration of insomnia greater than equal to 1 month and less than equal to 6 months. 5. Willing to participate and give written informed consent. 6. Patients able to comply with the study protocol and follow-up visits.

Exclusion criteria

Exclusion criteria: 1.Patient below 18 years and above 60 years. 2.Patients with severe insomnia (ISI score greater than 21) requiring higher medical intervention. 3. History of substance abuse, alcohol dependence. 4. Pregnant or lactating women. 5. Patients with major chronic illnesses (e.g., uncontrolled diabetes, cardiac disease, renal or hepatic impairment).

Design outcomes

Primary

MeasureTime frame
Improvement in sleep quality and duration (PSQI, ISI score reduction)Timepoint: At Baseline & after 1st weeks,2nd weeks and 4th weeks .

Secondary

MeasureTime frame
1. Absence of side effects 2. Improvement in patient-reported well-being 3. Reduction in anxiety & fatigueTimepoint: At Baseline ,1st weeks,2nd weeks, 4th weeks

Countries

India

Contacts

Public ContactDr Ananya Das

The West Bengal University of Health Sciences

nabanita.newhope@gmail.com9432682951

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026