Chamomile for Chronic Primary Insomnia
Avainsanat
Abstrakti
Kuvaus
Insomnia, defined as the inability to initiate or maintain sleep or lack of restorative sleep, is the most prevalent sleep complaint in primary care. Insomnia is associated with decreased quality of life, work limitations and increased healthcare utilization. Currently there is no treatment for chronic insomnia that is readily available, affordable, without significant side-effects and demonstrated to be safe for long term use. Consequently, treatments that would fill this gap are needed.
Chamomile (Matricaria recutita) has been used as a gentle sleep agent by herbalists for several hundred years. It has been studied in animals for its sedative potential and shows promise for treating insomnia. Currently, chamomile's sedative mechanisms of action are unknown, but are thought to be through the major inhibitory neurotransmitter in the central nervous system, γ - aminobutyric acid (GABA). However, no study has examined chamomile's efficacy and safety for treating insomnia.
The investigators propose a double-blind, placebo-controlled, randomized trial of chamomile in primary care patients with chronic insomnia. Thirty-four patients will be randomized to either Chamomile High Grade Extract, three 5 mg tablets standardized to 0.4% (-)-α-bisabolol twice daily or placebo and will be followed for 28 days for changes in a sleep diary (sleep efficiency, total sleep time, sleep-onset latency and sleep quality), insomnia severity and sleep disturbances. Secondary endpoints include assessing changes in day time functioning (measures of global quality of life, depression and anxiety) and monitoring for any signs of toxicity. The investigators will also determine the feasibility of conducting a larger trial with this agent.
Päivämäärät
| Viimeksi vahvistettu: | 09/30/2017 |
| Ensimmäinen lähetys: | 01/23/2011 |
| Arvioitu ilmoittautuminen lähetetty: | 01/26/2011 |
| Ensimmäinen lähetetty: | 01/30/2011 |
| Viimeisin päivitys lähetetty: | 10/05/2017 |
| Viimeisin päivitys lähetetty: | 11/06/2017 |
| Ensimmäisten tulosten toimittamispäivä: | 01/20/2013 |
| Ensimmäisten QC-tulosten toimittamispäivä: | 06/23/2013 |
| Ensimmäisten tulosten päivämäärä: | 07/29/2013 |
| Todellinen opintojen alkamispäivä: | 06/30/2008 |
| Arvioitu ensisijainen valmistumispäivä: | 11/30/2010 |
| Arvioitu tutkimuksen valmistumispäivä: | 11/30/2010 |
Ehto tai tauti
Interventio / hoito
Dietary Supplement: Chamomile High Grade Extract
Drug: Placebo Tablet
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Experimental: Chamomile High Grade Extract Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet | Dietary Supplement: Chamomile High Grade Extract three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days |
| Placebo Comparator: Placebo Tablet Contained lactose | Drug: Placebo Tablet |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 18 Years Vastaanottaja 18 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | All |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | Inclusion Criteria: - Men and women aged 18 to 64 years; - Must be able to give written informed consent; - Have a diagnosis of primary insomnia per DSM-IV criteria, reporting < 6.5 hours sleep and/or >30 minutes to fall asleep (SOL) and/or wake after sleep onset (WASO) > 30 minutes, three or more nights per week; - Present sleep complaint for at least 6 months; Exclusion Criteria: - Women who are pregnant, lactating or less than six months post-partum. Due to the fact that an assessment of reproductive performance and teratology tests have not been conducted we are excluding pregnant and lactating women; - Patients with unstable medical conditions; - DSM-IV Axis I or personality disorder diagnosis with the exception of patients with treated and stable unipolar depression or generalized anxiety disorder (such that the PRIME-MD scores are within normal range for these disorders); - Difficulty in sleep initiation or maintenance associated with known medical diagnosis or conditions that may affect sleep, e.g., sleep apnea, restless leg syndrome, chronic pain; - Evidence of lack of reliability or noncompliance as defined by missing a pretreatment appointment more than twice; - Current diagnosis of substance abuse or dependence; - Known allergy to chamomile or members of the ragweed family; - Currently taking cyclosporine, warfarin or chronic sedative and anxiolytic medications; - Prior use of insomnia medications is not exclusionary, but patients must be off of these medications at the screening visit and through out the study. |
Tulokset
Ensisijaiset tulosmittaukset
1. Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28. [baseline and day 28]
Toissijaiset tulosmittaukset
1. Change From Baseline of Chamomile on Daytime Functioning Measures: BDI [baseline and day 28]
2. Change From Baseline of Chamomile on Daytime Functioning Measures: STAI [Baseline and 28 days]
3. Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale [Baseline and 28 days]
4. Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ] [Baseline and 28 days]
5. Changes From Baseline in the Safety and Tolerability of Chamomile [once per week during study and day 28]
