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Effects of Herbal Sleep Formula on Patients With Insomnia and Tinnitus

NCT05212298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-02-04

No results posted yet for this study

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 582 mg.
3. Herbal compound high-dose group: once a day, four capsules each time. The total amount of herbal compound capsules is 1164 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

The gel contains a mixture of glucose and maltodextrin

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

DIETARY_SUPPLEMENT

Herbal compound low-dose

The total amount of herbal compound capsules is 582 mg.

DIETARY_SUPPLEMENT

Herbal compound high-dose

The total amount of herbal compound capsules is 1164 mg.

Sponsors & Collaborators

  • Dalin Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Juen-Haur Hwang, MD, PhD. · Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05212298 on ClinicalTrials.gov