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Clinical effect of Bushen Anshen Decoction Combined with Wuyin therapy on perimenopausal female insomnia patients with kidney deficiency and liver depression

Registration number：

ITMCTR2024000873

Date of Last Refreshed on：

2024-12-27

Date of Registration：

2024-12-27

Registration Status：

Prospective registration

Public title：

Clinical effect of Bushen Anshen Decoction Combined with Wuyin therapy on perimenopausal female insomnia patients with kidney deficiency and liver depression

English Acronym：

Clinical effect of Bushen Anshen Decoction Combined with Wuyin therapy on perimenopausal female insomnia patients with kidney deficiency and liver depression

Scientific title：

Clinical effect of Bushen Anshen Decoction Combined with Wuyin therapy on perimenopausal female insomnia patients with kidney deficiency and liver depression

Scientific title acronym：

Clinical effect of Bushen Anshen Decoction Combined with Wuyin therapy on perimenopausal female insomnia patients with kidney deficiency and liver depression

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yan Jun

Study leader：

Chen Pei

Applicant telephone：

02984696418

Study leader's telephone：

18408257161

Applicant Fax：

Study leader's fax：

Applicant E-mail：

263329976@qq.com

Study leader's E-mail：

chenpeii@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

112 Xiguan Main Street Lianhu District Xi'an Shaanxi

Study leader's address：

112 Xiguan Main Street Lianhu District Xi'an Shaanxi

Applicant postcode：

710082

Study leader's postcode：

710082

Applicant's institution：

Xi'an Fifth Hospital

Approved by ethic committee：

Approved No. of ethic committee：

（2024）伦审第（92）号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Xi'an Fifth Hospital

Date of approved by ethic committee：

2024/9/25 0:00:00

Contact Name of the ethic committee：

Guo Manyu

Contact Address of the ethic committee：

112 Xiguan Main Street Lianhu District Xi'an Shaanxi

Contact phone of the ethic committee：

+86 177 9592 0679

Contact email of the ethic committee：

yj84328@163.com

Primary sponsor：

Chen Pei

Primary sponsor's address：

112 Xiguan Main Street Lianhu District Xi'an Shaanxi

Secondary sponsor：

Country：

China

Province：

Shaanxi

City：

Xi'an

Institution
hospital：

Xi'an Fifth Hospital

Address：

112 Xiguan Main Street Lianhu District Xi'an Shaanxi

Source(s) of funding：

Shaanxi Provincial Administration of Traditional Chinese Medicine Research Project

Target disease：

Perimenopausal insomnia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

The main purpose is to evaluate the clinical effect of Bushen Anshen Decoction Combined with Wuyin therapy on perimenopausal insomnia patients with kidney deficiency and liver depression and explore its potential mechanism so as to provide a new treatment idea for the clinic.

Description for medicine or protocol of treatment in detail：

About 280 perimenopausal female insomnia patients with kidney deficiency and liver depression in our hospital were included and randomly divided into western medicine treatment group Bushen Anshen Decoction group Wuyin treatment group and combined treatment group. According to the corresponding treatment the patients were treated for 4 weeks and the changes of sleep quality emotional state quality of life neurotransmitters sex hormone levels and other indicators were observed.

Inclusion criteria

(1) Aged between 45 and 55 years old in the perimenopausal period; (2) Western medicine diagnosis: according to the international classification of sleep disorders it meets the relevant standards of insomnia (such as difficulty in falling asleep difficulty in maintaining sleep early awakening etc.); (3) The dialectical classification is kidney deficiency and liver depression; (4) No history of major diseases (such as serious heart disease liver and kidney dysfunction etc.) affecting treatment or sleep; (5) Voluntary participation in the study participants need to have treatment compliance voluntarily participate in the study and comply with the study protocol including regular follow-up and receiving treatment intervention; (6) And signed the informed consent.

Exclusion criteria：

(1) There are serious organic diseases (such as cardiovascular disease liver and kidney dysfunction etc.); (2) Have a history of mental illness or are receiving psychotherapy; (3) Previous ovariectomy hysterectomy or surgical treatment of uterus ovary and breast; (4) Pregnant or lactating women; (5) Taking other drugs that affect sleep such as sleeping pills.

Study execute time：

From 2025-01-01

To      2026-12-31

Recruiting time：

From 2025-01-01

To      2026-12-31

Interventions：

70

Group：

Western medicine group

Sample size：

Intervention：

Dexzopiclone + oryzanol

Intervention code：

70

Group：

Wuyin treatment group

Sample size：

Intervention：

Dexzopiclone + oryzanol+Wuyin therapy

Intervention code：

70

Group：

Bushen Anshen Decoction group

Sample size：

Intervention：

Dexzopiclone + oryzanol+Bushen Anshen Decoction

Intervention code：

70

Group：

Combined treatment group

Sample size：

Intervention：

Dexzopiclone + oryzanol+Bushen Anshen Decoction+Wuyin therapy

Intervention code：

Total sample size ： 280

Countries of recruitment
and research settings：

Country：

China

Province：

Shaanxi

City：

Xi'an

Institution/hospital：

Xi'an Fifth Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

SF-36

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

neurotransmitter

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

HAMA

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PSQI

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

sex hormone

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

HAMD

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

45
Min age years
55
Max age years

Recruiting status：

Participant age：

Gender：

Female

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random number table method

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

From January 2025 to December 2026 the original data will be publicly disclosed using Excel spreadsheets.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection: case record form; Data management: Excel table.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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