The efficacy of nutraceuticals in the treatment of chronic insomnia

A combination of herbs, vitamins, trace elements and essential amino acids in the treatment of patients with insomnia disorder associated with anxiety symptoms: an observational, pilot, open-label, prospective, eight-week study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN85501054

Enrollment

Registered

2024-07-30

Start date

2021-09-23

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

Treatment of patients suffering from chronic insomnia and anxiety states. Mental and Behavioural Disorders

Interventions

The study was conducted on a clinical sample of 28 patients suffering from insomnia disorder according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V), associ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients suffering from chronic insomnia according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders and the third edition of the International Classification of Sleep Disorders (DSM-V), associated with a state of anxiety.

Exclusion criteria

Exclusion criteria: 1. Major depressive disorders 2. Substance abuse disorders 3. Pregnancy 4. Unstable clinical status

Design outcomes

Primary

Measure	Time frame
Measured at baseline and week four: 1. The Pittsburgh Sleep Quality Index (PSQI) 2. STAI-Y1 (anxiety)	—

Secondary

Measure	Time frame
1. PSQI at baseline and eight weeks 2. STAI-Y2 at baseline and eight weeks 3. Beck Depression Inventory (BDI) at four and eight weeks 4. Fatigue Severity Scale (FSS) at four and eight weeks 5. Depression and Anxiety Scale Short form – 21 (DASS-21) at four and eight weeks 6. Patient global impression of improvement - severity (PGI-S) at four and eight weeks 7. Rapid Stress Assessment (RSA) at four and eight weeks 8. Insomnia Severity Index at four and eight weeks 9. General health (SF-36) at four and eight weeks	—

Measure

Time frame

1. PSQI at baseline and eight weeks 2. STAI-Y2 at baseline and eight weeks 3. Beck Depression Inventory (BDI) at four and eight weeks 4. Fatigue Severity Scale (FSS) at four and eight weeks 5. Depression and Anxiety Scale Short form – 21 (DASS-21) at four and eight weeks 6. Patient global impression of improvement - severity (PGI-S) at four and eight weeks 7. Rapid Stress Assessment (RSA) at four and eight weeks 8. Insomnia Severity Index at four and eight weeks 9. General health (SF-36) at four and eight weeks

—

Countries

Italy

Contacts

Public ContactGianluca Bruti

dip.odonto@cert.uniroma1.it+39-06-4997661

Outcome results

None listed

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