Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus

NCT05212298 | Completed

• 1 other identifier: A10804001-4
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 1.Control group: receive placebo treatment, once a day, four pills each time.
2. 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 582 mg.
3. 3.Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg.

Conditions

Sleep Disturbances; Tinnitus

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each aspect has a minimum score of 0 and a maximum of 3 points. The total score range is 0-21 points. When the PSQI score is greater than 5 points, it indicates that there is a sleep quality disorder. The higher the score, the worse the sleep quality.

  3 month

• Tinnitus Handicap Inventory

  The Tinnitus Handicap Inventory (THI) comprises 25 items grouped into three subscales: Functional, Emotional, and Catastrophic. The Functional subscale (11 items) deals with limitations caused by tinnitus in the areas of mental, social, and physical functioning. The Emotional subscale (9 items) concerns affective responses to tinnitus, e.g. anger, frustration, depression, anxiety. The Catastrophic subscale (5 items) probes the most severe reactions to tinnitus, such as loss of control, inability to escape from tinnitus, and fear of having a terrible disease. For each item a patient can respond with a "yes" (scored 4 points), "sometimes" (2 points), or "no" (0 points). The responses are summed within each subscale and for the total scale. The higher the score, the greater the perceived tinnitus severity.

  3 month

Study Arms (3)

Control

PLACEBO COMPARATOR

receive placebo treatment, once a day, four pills each time.

Dietary Supplement: The gel contains a mixture of glucose and maltodextrin

Herbal compound low-dose

EXPERIMENTAL

once a day, two herbal compound capsules and two placebos each time. The total amount of herbal compound capsules is 582 mg.

Dietary Supplement: Herbal compound low-dose

Herbal compound high-dose

EXPERIMENTAL

once a day, four capsules each time. The total amount of herbal compound capsules is 1164 mg.

Dietary Supplement: Herbal compound high-dose

Interventions

The gel contains a mixture of glucose and maltodextrin DIETARY_SUPPLEMENT

The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.

Control

Herbal compound low-dose DIETARY_SUPPLEMENT

The total amount of herbal compound capsules is 582 mg.

Herbal compound low-dose

Herbal compound high-dose DIETARY_SUPPLEMENT

The total amount of herbal compound capsules is 1164 mg.

Herbal compound high-dose

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20\~70 years old
• Non-dialysis patients
• Suffering from sleep disorders and tinnitus
• Refuse to take sleeping pills

You may not qualify if:

• Patients who are bedridden or unable to take care of themselves.
• dialysis patients.
• Patients who cannot understand the details of this study or cannot cooperate with the examination.
• History of alcohol or drug abuse.
• Pregnant and lactating women
• Patients with moderate to severe sleep apnea
• Take sleeping pills

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Study Sites (1)

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Chiayi City, 66247, Taiwan

Location

MeSH Terms

Conditions

Parasomnias; Tinnitus

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juen-Haur Hwang, MD, PhD.

  Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: January 28, 2022
• Study Start: September 16, 2021
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

TW (1)