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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05212298
Other study ID # A10804001-3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 16, 2021
Est. completion date January 30, 2025

Study information

Verified date August 2023
Source Dalin Tzu Chi General Hospital
Contact Juen-Haur Hwang, MD, PhD.
Phone +886-5-2648000
Email g120796@tzuchi.com.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.
Herbal compound low-dose
The total amount of herbal compound capsules is 557 mg.
Herbal compound high-dose
The total amount of herbal compound capsules is 1114 mg.

Locations

Country Name City State
Taiwan Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation Chiayi City

Sponsors (1)

Lead Sponsor Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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