Herbal Pillows for Sleep Disorders

(SSS Trial)

Overseen By Paula A. Witt-Enderby, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duquesne University

Must not be taking: Antidepressants, Anxiolytics, Opioids, others

Disqualifiers: COPD, Insomnia, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

50 Participants Needed

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. ^{1 2 3 4 5}

Are 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. ^{6 7 8 9 10}

How 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. ^{1 2 5 11 12}

Research Team

Paula A. Witt-Enderby

Principal Investigator

Duquesne University

Eligibility 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

Exclusion Criteria

I cannot inhale properly due to a condition like COPD or using a CPAP machine.

Chemical sensitivities

Allergies

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

Treatment Details

Interventions

• Herbal Pillows

Trial Overview 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.

Participant Groups

Group I: Vata Pillow Experimental Treatment 1 Intervention

Group II: Pitta Pillow Experimental Treatment 1 Intervention

Group III: Kapha Pillow Experimental Treatment 1 Intervention

Group IV: Control Pillow Active Control 1 Intervention

Group V: Placebo Pillow Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Duquesne University

Lead Sponsor

Trials

33

Recruited

2,500+

Cura Rest/Healing and Yoga Arts

Collaborator

Trials

1

Recruited

50+

Findings from Research

The hydro-alcoholic extract of Capparis spinosa (HAE) significantly increased sleep duration in mice, showing hypnotic effects comparable to the well-known sedative diazepam, indicating its potential as a natural treatment for sleep disorders.

HAE demonstrated a high safety profile with an LD50 of 2.4 g/kg and did not show cytotoxic effects in L929 cells or impair motor coordination in the rotarod test, suggesting it may be a safe option for further research in sleep disorder treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypnotic Activity of Capparis spinosa Hydro-alcoholic Extract in Mice. Rakhshandeh, H., Rashidi, R., Vahedi, MM., et al.[2021]

The use of herbal preparations for sleep issues among adults in the U.S. has significantly increased from 2.5% to 12.4% over the past decade, highlighting a growing interest in alternative remedies.

Health care professionals need to be informed about the pharmacological properties of commonly used herbal sleep aids and wake-promoting products to better educate their patients on safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. Merritt, SL., Gyllenhaal, C., Peterson, SD., et al.[2015]

A large-scale study in Taiwan identified 16,134 patients treated with Chinese herbal medicine (CHM) for insomnia in 2002, with a notable preference for female patients (nearly double that of males).

The most frequently prescribed CHM was Shou-wu-teng, and while the study highlights common usage patterns, it emphasizes the need for further clinical trials to assess the efficacy and safety of these herbal treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescriptions of Chinese Herbal Medicines for Insomnia in Taiwan during 2002. Chen, FP., Jong, MS., Chen, YC., et al.[2022]

In a study involving 91 participants with primary insomnia, NSF-3, a polyherbal sedative-hypnotic, showed significant improvements in sleep metrics similar to those achieved with zolpidem, indicating its efficacy as a treatment option.

Both NSF-3 and zolpidem were found to be safe, with mild treatment-emergent adverse events reported, but no serious side effects, suggesting that NSF-3 could be a viable alternative for short-term use in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: a randomized controlled trial. Maroo, N., Hazra, A., Das, T.[2021]

About 50% of people will experience a sleep disorder in their lifetime, leading to growing interest in plant-based supplements for treatment.

The review evaluates the safety and effectiveness of six common sleep aids, including chamomile and valerian, highlighting that the quality of evidence supporting their use varies significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on Nutraceutical Sleep Therapeutics and Investigational Research. Yurcheshen, M., Seehuus, M., Pigeon, W.[2023]

In a pilot study involving 549 herbalists in the UK, 194 patients reported on their experiences with Chinese herbal medicine, with 14% experiencing adverse events such as diarrhea, fatigue, and nausea, but no serious adverse events were noted.

First-time patients were more likely to report adverse events compared to those who had previously consulted herbalists, indicating that prior experience may reduce the likelihood of experiencing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. MacPherson, H., Liu, B.[2018]

In a study involving 25 healthy volunteers with sleep onset insomnia, a traditional Ayurvedic herbal supplement significantly reduced sleep latency by an average of 16.72 minutes compared to a placebo (P=0.003).

The supplement was found to be safe, with no self-reported side effects, suggesting it could be a beneficial alternative to conventional sleep medications that often have negative side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised-controlled trial of the effects of a traditional herbal supplement on sleep onset insomnia. Farag, NH., Mills, PJ.[2019]

There is a growing trend in medical journals to publish case reports of adverse reactions to herbal therapies, indicating an increasing awareness of their potential hazards.

Most serious adverse events associated with herbal therapies are linked to issues of product quality or adulteration, highlighting the importance of ensuring safe herbal practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects associated with herbal medicine. Pinn, G.[2012]

A study analyzing spontaneous adverse drug reaction reports from 2000 to 2013 found that St. John's Wort, a common herbal treatment for depression, can cause adverse effects similar to those of fluoxetine, a conventional SSRI antidepressant, with both affecting the central nervous system.

The majority of reported adverse reactions for both St. John's Wort and fluoxetine were observed in females aged 26-50 years, highlighting the need for increased awareness of the potential risks associated with herbal medicines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000-2013. Hoban, CL., Byard, RW., Musgrave, IF.[2015]

Many consumers mistakenly believe that herbal products are safe simply because they are natural, which can lead to potential health risks.

Key safety concerns with herbal products include insufficient safety data, lack of quality control for potency and purity, and inadequate labeling standards, highlighting the need for caution when using these remedies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues with herbal products. Marrone, CM.[2019]

A survey of over-the-counter sleeping pills in Hong Kong identified 17 brands, with the most common being a Chinese herbal mixture called suanzaorentang, which includes several herbal ingredients and 3 mg of melatonin in some products.

Despite some herbs like kava, valerian, and melatonin being better researched, the current evidence on their effectiveness and safety for treating insomnia is insufficient, highlighting the need for more rigorous studies on these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-counter sleeping pills: a survey of use in Hong Kong and a review of their constituents. Chung, KF., Lee, CK.[2022]

Herbal medicines are increasingly popular for treating sleep disorders, with caffeine being a common stimulant found in various beverages, though more research is needed to understand its effects on sleep issues.

Valerian and kava have shown promise in reducing sleep onset time and improving sleep quality in small studies, while other herbs like chamomile and lavender require further investigation to confirm their sedative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of herbal stimulants and sedatives in sleep disorders. Gyllenhaal, C., Merritt, SL., Peterson, SD., et al.[2019]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Hypnotic Activity of Capparis spinosa Hydro-alcoholic Extract in Mice. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Prescriptions of Chinese Herbal Medicines for Insomnia in Taiwan during 2002. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: a randomized controlled trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Updates on Nutraceutical Sleep Therapeutics and Investigational Research. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. [2018]

7. Scotland pubmed.ncbi.nlm.nih.gov

A randomised-controlled trial of the effects of a traditional herbal supplement on sleep onset insomnia. [2019]

8. Australia pubmed.ncbi.nlm.nih.gov

Adverse effects associated with herbal medicine. [2012]

9. Australia pubmed.ncbi.nlm.nih.gov

A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000-2013. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Safety issues with herbal products. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Over-the-counter sleeping pills: a survey of use in Hong Kong and a review of their constituents. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of herbal stimulants and sedatives in sleep disorders. [2019]