Herbal treatment for insomnia and tinnitus
Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus: Prospective, Randomized, Double-blinded Clinical Trial
NA · Dalin Tzu Chi General Hospital · NCT05212298
This study is testing if an herbal sleep formula can help adults with insomnia and tinnitus who don’t want to use regular sleep medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Dalin Tzu Chi General Hospital (other) |
| Locations | 1 site (Chiayi City) |
| Trial ID | NCT05212298 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effects of an herbal sleep formula on non-dialysis adults suffering from insomnia and tinnitus who refuse conventional sleeping medications. Participants will be randomly assigned to one of three groups: a control group receiving a placebo, a low-dose herbal compound group, or a high-dose herbal compound group. The study will assess the impact of these treatments on sleep and tinnitus symptoms through health questionnaires administered before and after a three-month treatment period.
Who should consider this trial
Good fit: Ideal candidates are non-dialysis adults aged 20 to 70 who experience sleep disturbances and tinnitus and refuse to take sleeping pills.
Not a fit: Patients who are bedridden, on dialysis, or have severe sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a natural alternative treatment for patients suffering from insomnia and tinnitus.
How similar studies have performed: While there is limited data on herbal treatments for these conditions, some studies have shown promising results with similar approaches, though this specific combination is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 20\~70 years old 2. Non-dialysis patients 3. Suffering from sleep disorders and tinnitus 4. Refuse to take sleeping pills Exclusion criteria: 1. Patients who are bedridden or unable to take care of themselves. 2. dialysis patients. 3. Patients who cannot understand the details of this study or cannot cooperate with the examination. 4. History of alcohol or drug abuse. 5. Pregnant and lactating women 6. Patients with moderate to severe sleep apnea 7. Take sleeping pills
Where this trial is running
Chiayi City
- Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — Chiayi City, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Juen-Haur Hwang, MD, PhD.
- Email: g120796@tzuchi.com.tw
- Phone: +886-5-2648000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Disturbances, Tinnitus