A study to evaluate the benefit of adding probiotics to standard treatment in patients with chronic insomnia.

A Prospective Study to Compare the Clinical Efficacy of Probiotics as an Adjuvant to Standard Therapy in Patients With Chronic Insomnia in a Tertiary Care Centre in South India - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100559

Enrollment

Registered

2026-01-08

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: G470- Insomnia

Interventions

Intervention1: LACTOBACILLUS RHAMNOSUS: Standard therapy with probiotics as adjuvant drugs once a day before bed, daily for 4weeks Control Intervention1: STANDARD THERAPY: Standard therapy for chroni

Eligibility

Inclusion criteria

Inclusion criteria: Male or female adults aged 18 45 years Male or female patient with diagnosis of chronic insomnia as per DSM-5 criteria Patients willing to give written and informed consent

Exclusion criteria

Exclusion criteria: Current use of antibiotics or probiotics within the past month Diagnosed gastrointestinal diseases Major psychiatric or neurological disorders Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
To assess the effect of probiotic supplementation on sleep quality in patients with chronic insomnia.Timepoint: 4weeks	—

Secondary

Measure	Time frame
To evaluate changes in sleep latency To assess changes in sleep efficiency. Timepoint: 6weeks	—

Countries

India

Contacts

Public ContactDr Sridevi S A

ACS Medical College and Hospital

vishnupriya14696@gmail.com9790216057

Outcome results

None listed

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