Herbal Pillows for Sleep Disorders
(SSS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Duquesne University
Must not be taking: Antidepressants, Anxiolytics, Opioids, others
Disqualifiers: COPD, Insomnia, Pregnancy, others
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine the effect of herbal pillows on sleep and quality of life in a healthy population using actigraphy, validated questionnaires and daily diary logs. The goal of this study is to improve sleep and quality of life using herbal and Ayurveda/holistic-based botanical pillows.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications or substances that can affect mood or sleep, including prescription drugs like anti-depressants and over-the-counter products like melatonin.
What data supports the effectiveness of the treatment Herbal Pillows for sleep disorders?
Research indicates that herbal remedies, including those with ingredients like valerian and chamomile, have been used to help with sleep issues. Additionally, Chinese herbal medicine has been commonly used for treating insomnia, suggesting potential benefits of plant-based treatments for sleep disorders.
12345Are herbal pillows safe for use in humans?
Herbal products, including those used for sleep, can have adverse effects similar to prescription medications, and issues often arise from product quality or adulteration. It's important to be aware that herbs can interact with other medications, which can be hazardous if not properly managed.
678910How do herbal pillows differ from other treatments for sleep disorders?
Herbal pillows are unique because they use natural plant materials, like chamomile and lavender, to promote sleep through their calming scents, unlike conventional drugs that often work by altering brain chemistry. This makes them a non-invasive and potentially safer option for those who prefer to avoid medication.
1251112Eligibility Criteria
This trial is for healthy individuals experiencing sleep issues or poor quality of life due to mental health concerns. Participants should be interested in trying holistic approaches like Ayurveda.Inclusion Criteria
Must be willing to adhere to a sleep hygiene protocol for 2 weeks without interruption in the comfort of your home
Must be willing to refrain from alcohol and anything that can affect mood and sleep during the testing period
Must be willing to wear a watch that monitors sleep and light as well as a sleep mask for two consecutive weeks
+4 more
Exclusion Criteria
I cannot inhale properly due to a condition like COPD or using a CPAP machine.
Chemical sensitivities
Allergies
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants use herbal pillows to assess effects on sleep and quality of life
2 weeks
Daily diary logs and actigraphy assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
Participant Groups
The study is testing whether sleeping on herbal pillows can improve sleep and overall well-being. It involves tracking sleep patterns with actigraphy, answering questionnaires, and keeping a daily diary.
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Vata PillowExperimental Treatment1 Intervention
Group II: Pitta PillowExperimental Treatment1 Intervention
Group III: Kapha PillowExperimental Treatment1 Intervention
Group IV: Control PillowActive Control1 Intervention
Group V: Placebo PillowPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duquesne UniversityPittsburgh, PA
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Who Is Running the Clinical Trial?
Duquesne UniversityLead Sponsor
Cura Rest/Healing and Yoga ArtsCollaborator
References
Hypnotic Activity of Capparis spinosa Hydro-alcoholic Extract in Mice. [2021]Sleep disorders are among the most common psychiatric and medical conditions. Herbal medicine appears to be effective in the treatment of sleep disorders which have been valued by many of publications and patents.
Herbal remedies: efficacy in controlling sleepiness and promoting sleep. [2015]Difficulties with sleep and daytime sleepiness are common complaints among adults in the United States. During the past decade, the use of herbal preparations among adults increased from 2.5% to 12.4%. This article presents relevant aspects of the 1994 Dietary Supplements Health and Education Act that stimulated the proliferation of herbal medicinals and reviews the pharmacological properties of the most commonly available herbal wake-promoting and sedating products. Given the rapid increase in use of herbals, health care professionals need to educate themselves and their patients about the use of these preparations.
Prescriptions of Chinese Herbal Medicines for Insomnia in Taiwan during 2002. [2022]Chinese herbal medicine (CHM) has been commonly used for treating insomnia in Asian countries for centuries. The aim of this study was to conduct a large-scale pharmaco-epidemiologic study and evaluate the frequency and patterns of CHM use in treating insomnia. We obtained the traditional Chinese medicine (TCM) outpatient claims from the National Health Insurance in Taiwan for the year 2002. Patients with insomnia were identified from the diagnostic code of International Classification of Disease among claimed visiting files. Corresponding prescription files were analyzed, and an association rule was applied to evaluate the co-prescription of CHM. Results showed that there were 16 134 subjects who visited TCM clinics for insomnia in Taiwan during 2002 and received a total of 29 801 CHM prescriptions. Subjects between 40 and 49 years of age comprised the largest number of those treated (25.3%). In addition, female subjects used CHMs for insomnia more frequently than male subjects (female : male = 1.94 : 1). There was an average of 4.8 items prescribed in the form of either an individual Chinese herb or formula in a single CHM prescription for insomnia. Shou-wu-teng (Polygonum multiflorum) was the most commonly prescribed single Chinese herb, while Suan-zao-ren-tang was the most commonly prescribed Chinese herbal formula. According to the association rule, the most commonly prescribed CHM drug combination was Suan-zao-ren-tang plus Long-dan-xie-gan-tang, while the most commonly prescribed triple drug combination was Suan-zao-ren-tang, Albizia julibrissin, and P. multiflorum. Nevertheless, further clinical trials are needed to evaluate the efficacy and safety of these CHMs for treating insomnia.
Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: a randomized controlled trial. [2021]To assess the efficacy and safety of NSF-3, a polyherbal sedative-hypnotic (containing standardized extracts of Valeriana officinalis, Passiflora incarnate and Humulus lupulus), in comparison to zolpidem in primary insomnia.
Updates on Nutraceutical Sleep Therapeutics and Investigational Research. [2023]Approximately 50% of the population will suffer from a sleep disorder over the course of their lifetime. There is increasing interest in nutraceuticals for these conditions. The quality of the evidence for the safety and effectiveness of using these supplements to treat sleep disorders varies substantially. In this review, we discuss the data about the effectiveness and safety of six commonly used plant-based sleep therapeutics: caffeine, chamomile, cherries, kava kava, L-tryptophan, marijuana, and valerian. We explore both historical uses of each substance and the current state of the literature.
The safety of Chinese herbal medicine: a pilot study for a national survey. [2018]The aim of this study was to establish the feasibility of conducting a national safety survey involving patients of herbalists monitoring and reporting adverse events associated with the routine practice of Chinese herbal medicine.
A randomised-controlled trial of the effects of a traditional herbal supplement on sleep onset insomnia. [2019]To study the effectiveness and safety of a traditional herbal supplement used for sleep onset insomnia.
Adverse effects associated with herbal medicine. [2012]Medical journals are now publishing case reports of adverse reactions to herbal therapy. With increasing use, and more importantly, increasing awareness of potential hazardous effects, these reports are liable to increase in frequency. It is also increasingly realised that herbs and drugs can interact in the same way that drug/drug interactions occur. This is particularly hazardous for the patient if the treating doctor is not aware of the herbal prescription. This article reviews the published material and highlights areas of major concern. Most of the serious adverse events reported relate to problems of product quality or adulteration.
A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000-2013. [2015]Herbal medicines are perceived to be safe by the general public and medical practitioners, despite abundant evidence from clinical trials and case reports that show herbal preparations can have significant adverse effects. The overall impact of adverse events to herbal medicines in Australia is currently unknown. Post marketing surveillance of medications through spontaneous adverse drug reaction (ADR) reports to the Therapeutic Goods Administration (TGA) is one way to estimate this risk. The patterns of spontaneously reported ADRs provide insight to herbal dangers, especially when compared with patterns of a mechanistically similar conventional drug. The study compared the pattern of spontaneously reported ADRs to St. John's Wort (Hypericum perforatum), a common herbal treatment for depression which contains selective serotonin reuptake inhibitors (SSRI), to fluoxetine, a commonly prescribed synthetic SSRI antidepressant. Spontaneous ADR reports sent to the TGA between 2000-2013 for St. John's Wort (n = 84) and fluoxetine (n = 447) were obtained and analysed. The demographic information, types of interaction, severity of the ADR, and the body systems affected (using the Anatomical Therapeutic Chemical classification system) were recorded for individual ADR cases. The majority of spontaneously reported ADRs for St. John's Wort and fluoxetine were concerning females aged 26-50 years (28.6%, 22.8%). The organ systems affected by ADRs to St John's Wort and fluoxetine have a similar profile, with the majority of cases affecting the central nervous system (45.2%, 61.7%). This result demonstrates that herbal preparations can result in ADRs similar to those of prescription medications.
Safety issues with herbal products. [2019]To review safety issues associated with the use of herbal products.
Over-the-counter sleeping pills: a survey of use in Hong Kong and a review of their constituents. [2022]This study examined the composition of over-the-counter (OTC) sleeping pills in Hong Kong and reviewed the current knowledge about the hypnotic efficacy and safety of their major herbal and dietary supplement constituents. We conducted a cross-sectional survey of OTC sleep aids at drug stores in a residential district of 0.3 million population and literature search using MEDLINE, EMBASE, PsycINFO, China Journal Net, China Biomedical Database and relevant English and Chinese literature. We identified 17 brands of OTC sleeping pill: eleven of them were composed of mixtures of Chinese and Western herbal agents and six brands contained 3 mg of melatonin. The Chinese herbal mixture suanzaorentang, comprising zizyphi spinosi semen, poria cocos, ligusticum wallichii, anemarrhenae rhizoma and glycyrrhizae radix in ratio of 7:5:2:1:1, was the most common OTC sleeping pill available in the survey. Our literature review showed that kava, valerian and melatonin were the better-researched herbs and dietary supplements, however, the data on hypnotic efficacy and safety was inadequate to support their clinical use. More rigorous investigations of the risk-benefit relationship of herbal agents and dietary supplements used for insomnia are needed.
Efficacy and safety of herbal stimulants and sedatives in sleep disorders. [2019]World-wide use of herbal medicines is increasing, following regulatory and manufacturing developments. Herbs are attractive alternative medications to many patients with sleep disorders, who may be averse to using conventional drugs. We review here the most common herbal stimulants and sedatives. Caffeine, in herbal teas, black tea, coffee, soft drinks and pharmaceuticals, is used widely to control sleepiness, but more research is needed on its use in sleep disorders. Ephedra, and its constituent ephedrine, are used in both stimulant and weight loss preparations, sometimes with caffeine; safety concerns have arisen with this practice. Yohimbe is another herb used in stimulant and body-building preparations which has safety concerns. Asian and Siberian ginseng have been traditionally used for fatigue, and have some supportive experimental evidence for this use. Herbal sedatives also have some evidence for efficacy; the observations that certain plant flavonoid compounds bind to benzodiazepine receptors adds interest to their use. Valerian and kava have received the most research attention; both have decreased sleep onset time and promoted deeper sleep in small studies, and kava also shows anxiolytic effects. German chamomile, lavender, hops, lemon balm and passionflower are reputed to be mild sedatives but need much more experimental examination.