The efficacy of nutraceuticals in the treatment of chronic insomnia
| ISRCTN | ISRCTN85501054 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85501054 |
| Secondary identifying numbers | 0000698 |
- Submission date
- 18/07/2024
- Registration date
- 30/07/2024
- Last edited
- 24/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Sleep disorders and anxiety disorders, in addition to constituting a complex syndrome, represent a clinical condition in which various interconnected pathophysiological mechanisms contribute to determining the clinical phenotype.
Therefore, the ideal drug in these patients, in addition to having an anxiolytic and hypno-inducing action, should have a modulatory action on chronic stress, mood, inflammatory state, with a therapeutic action also on the cognitive and physical dimensions of the clinical syndrome.
A natural supplement dedicated to a population of patients suffering from sleep disorders associated with specific and non-specific states of anxiety might be made up of 4 distinct therapeutic principles (plant extracts, amino acids, vitamins, minerals) with a strengthening action on the physiological mechanisms responsible for regulating the sleep-wake rhythm and the homeostasis of the neurotransmitter and immune systems involved in the regulation of the state of alertness, mood and the hypothalamic-pituitary-adrenal axis.
The therapeutic rationale is based on the principle of the synergy of action exerted by constituents, such as plant extracts, capable of exerting a direct action on the GABA-A receptors implicated in the induction of sleep and on the mechanisms of chronic inflammation; the precursor amino acids for the synthesis of substances such as GABA, melatonin, dopamine and serotonin; vitamins, enzymatic catalysts for the synthesis of molecules involved in the regulation of the circadian rhythm and mood states; minerals, essential as cofactors for the correct functioning of neurotransmitters, neuro-hormones, and the chemical reactions connected to them. The main objective of this prospective, observational, open-label study, lasting eight weeks, was to evaluate the efficacy and safety of a phytotherapeutic and nutraceutical compound in a sample of patients suffering from insomnia disorder associated with states of anxiety.
Who can participate?
Patients suffering from insomnia disorder according to the DSM-V criteria, associated with a state of anxiety measured according to STAI-Y1/Y2.
What does the study involve?
All participants received the same sachet of powdered herbal mixture, vitamins, essential amino acids and trace elements to be taken one per day one hour before falling asleep
What are the possible benefits and risks of participating?
The pharmacological properties of the compound under study and the related benefits, would be to reduce the state of hypervigilance and consequently, improve the quantity and quality of sleep. No concerns about the safety profile of the study compound, were anticipated
Where is the study run from?
Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
April 2018 to October 2022
Who is funding the study?
Ecupharma S.r.l. (Italy)
Who is the main contact?
Dr Gianluca Bruti, gianluca.bruti@gmail.com
Contact information
Public, Scientific, Principal Investigator
Antonio Bertoloni avenue, 26 C
Rome
00197
Italy
| Phone | +39-06-4997661 |
|---|---|
| dip.odonto@cert.uniroma1.it |
Study information
| Study design | Observational prospective open-label |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | 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 |
| Study objectives | To evaluate the efficacy and safety of a nutraceutical compound composed of a combination of herbs, vitamins, trace elements and essential amino acids in the treatment of patients with chronic insomnia associated with anxiety. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This study was performed in a private office and did not require any institutional regulation. |
| Health condition(s) or problem(s) studied | Treatment of patients suffering from chronic insomnia and anxiety states. |
| Intervention | 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), associated with a state of anxiety. The sample study was clinically evaluated at baseline (T0), and after four (T1) and eight weeks (T2) of phytotherapeutic and nutraceutical treatment. There was no further systematic follow-up after the eight-week study |
| Intervention type | Other |
| Primary outcome measure | Measured at baseline and week four: 1. The Pittsburgh Sleep Quality Index (PSQI) 2. STAI-Y1 (anxiety) |
| Secondary outcome measures | 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 |
| Overall study start date | 21/04/2018 |
| Completion date | 25/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 28 |
| Key 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. |
| Key exclusion criteria | 1. Major depressive disorders 2. Substance abuse disorders 3. Pregnancy 4. Unstable clinical status |
| Date of first enrolment | 23/09/2021 |
| Date of final enrolment | 20/09/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00197
Italy
Sponsor information
University/education
Caserta Avenue 6
Rome
00161
Italy
| Phone | +39 0649976611 |
|---|---|
| dip.odonto@cert.uniroma1.it | |
| Website | http://www.uniroma1.it/ |
"ROR" |
https://ror.org/02be6w209 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request Gianluca Bruti; gianluca.bruti@gmail.com |
Editorial Notes
24/07/2024: Trial's existence confirmed by Sapienza University of Rome.
