Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus: Prospective, Randomized, Double-blinded Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project is planned to collect non-dialysis adults who suffer from sleep and tinnitus disorders and refuse to take sleeping medicines in our hospital by random assignment and double-blind method. 120 adults were divided into 3 groups. 1. Control group: receive placebo treatment, once a day, four pills each time. 2. Herbal compound low-dose group: once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 557 mg. 3. Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1114 mg. All subjects received health questionnaire, sleep questionnaire and tinnitus questionnaire before the start of the test At the end of the treatment(3 months), the health questionnaire, sleep questionnaire, and tinnitus questionnaire were accepted.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 20\

⁃ 70 years old

• Non-dialysis patients

• Suffering from sleep disorders and tinnitus

• Refuse to take sleeping pills

Locations
Other Locations
Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
RECRUITING
Chiayi City
Contact Information
Primary
Juen-Haur Hwang, MD, PhD.
g120796@tzuchi.com.tw
+886-5-2648000
Time Frame
Start Date: 2021-09-16
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 120
Treatments
Placebo_comparator: Control
receive placebo treatment, once a day, four pills each time.
Experimental: Herbal compound low-dose
once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 557 mg.
Experimental: Herbal compound high-dose
once a day, four capsules each time. The total amount of herbal compound capsules is 1114 mg.
Related Therapeutic Areas
Sponsors
Leads: Dalin Tzu Chi General Hospital

This content was sourced from clinicaltrials.gov