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Clinical study of "Shuganzhixuan decoction" in the treatment of residual dizziness (syndrome of liver-depression and spleen-deficiency) of primary BPPV after reposition

Registration number：

ITMCTR2024000745

Date of Last Refreshed on：

2024-11-27

Date of Registration：

2024-11-27

Registration Status：

Prospective registration

Public title：

Clinical study of "Shuganzhixuan decoction" in the treatment of residual dizziness (syndrome of liver-depression and spleen-deficiency) of primary BPPV after reposition

English Acronym：

Scientific title：

Clinical study of "Shuganzhixuan decoction" in the treatment of residual dizziness (syndrome of liver-depression and spleen-deficiency) of primary BPPV after reposition

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Ding Lei

Study leader：

Ding Lei

Applicant telephone：

13641259195

Study leader's telephone：

13641259195

Applicant Fax：

Study leader's fax：

Applicant E-mail：

soulyyt@163.com

Study leader's E-mail：

soulyyt@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 6 Fangxingyuan Community 1 Fangzhuang Fengtai District Beijing

Study leader's address：

No. 6 Fangxingyuan Community 1 Fangzhuang Fengtai District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Dongfang Hospital of Beijing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

JDF-IRB-2024032001

Approved file of Ethical Committee：

View

Name of the ethic committee：

Clinical Research Ethics Committee of Dongfang Hospital Beijing University of Chinese Medicine

Date of approved by ethic committee：

2024/10/14 0:00:00

Contact Name of the ethic committee：

Xia Yun

Contact Address of the ethic committee：

Room 444 South Branch East Building Dongfang Hospital No. 6 Fangxingyuan District 1 Fangzhuang Fengtai District Beijing.

Contact phone of the ethic committee：

01067654807

Contact email of the ethic committee：

dfyyec@126.com

Primary sponsor：

Dongfang Hospital of Beijing University of Chinese Medicine

Primary sponsor's address：

No. 6 Fangxingyuan Community 1 Fangzhuang Fengtai District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Beijing Municipal Health Commission

Address：

No. 6 Yard Daji StreetTongzhou District Beijing

Country：

China

Province：

Beijing

City：

Institution
hospital：

Dongfang Hospital of Beijing University of Chinese Medicine

Address：

No. 6 Fangxingyuan Community 1 Fangzhuang Fengtai District Beijing

Source(s) of funding：

Capitals Funds for Health Improvement and Research

Target disease：

Benign Paroxysmal Positional Vertigo (BPPV)

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

By evaluating the clinical effectiveness of "Shugan Zhixuan Decoction" in treating residual dizziness (syndrome of liver depression and spleen deficiency) after BPPV (benign paroxysmal positional vertigo) repositioning we aim to promote the transformation of Professor Liu Daxin's experience-based prescription into hospital preparations and patent applications ;provide high-quality and reliable evidence for optimizing the treatment of residual dizziness and better inherit and promote the experience of famous old Chinese medicine practitioners.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the definitive diagnostic criteria for primary BPPV; (2) Successful CRP repositioning with residual dizziness (RD) present; (3) RD duration ≤ 2 weeks; (4) Meet the diagnostic criteria for syndrome of liver stagnation and spleen deficiency; (5) Aged between 18 and 70 years old and both genders are eligible; (6) Participants have been fully informed about the study and have signed the informed consent form.

Exclusion criteria：

(1) Mixed-type BPPV involving 2-3 semicircular canals; (2) Inability to complete mCTSIB or SVV testing due to physical disabilities or other reasons; (3) Concurrent with other severe primary diseases in other organs or systems or mental illnesses; (4) Pregnant and lactating women as well as those with recent plans for pregnancy; (5) Sensitive constitution with known intolerance to the medications used in this study; (6) Participation in other drug clinical studies within the last 3 months.

Study execute time：

From 2024-01-01

To      2026-12-31

Recruiting time：

From 2024-12-01

To      2026-12-31

Interventions：

80

Group：

Control group

Sample size：

Intervention：

Shugan Zhixuan Decoction Granule Placebo

Intervention code：

80

Group：

Experimental group

Sample size：

Intervention：

Shugan Zhixuan Decoction Granule Preparation

Intervention code：

Total sample size ： 160

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Institution/hospital：

Dongfang Hospital of Beijing University of Chinese Medicine

Level of the institution：

Grade A tertiary hospital

Outcomes：

Outcome：

Subjective Visual Vertical Test

Type：

Secondary indicator

Measure time point of outcome：

Evaluate once before treatment and once after the end of treatment (D1, D15).

Measure method：

Conduct the detection in a darkroom. The examinees should sit upright and look at the visual target. Adjust the seat properly, adjust the visual target line to the corresponding position and then confirm it. The computer will measure the angular relationship. Conduct two pre-checks first, and repeat the formal examination three times and take the average value.

Outcome：

Dizziness Handicap Inventory

Type：

Primary indicator

Measure time point of outcome：

Evaluate once before treatment and once after the end of treatment (D1, D15).

Measure method：

Evaluate patients with the Dizziness Handicap Inventory (DHI). The inventory has 25 items and assesses dizziness symptoms from the aspects of physical, emotional and functional dimensions. Each item is scored from 0 to 4 points, with a total score of 100 points. The higher the score, the more severe the dizziness and the greater the impact on patients.

Outcome：

Modified Clinical Test of Sensory Integration and Balance

Type：

Secondary indicator

Measure time point of outcome：

Evaluate once before treatment and once after the end of treatment (D1, D15).

Measure method：

The examination is conducted in a quiet and bright room. Examinees take off their shoes and socks, stand vertically on a flat plate and try to stand steadily. Static postures under four standing conditions are tested, with three trials for each condition. The average sway velocity of the three tests is used as the evaluation criterion for postural stability.

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The experimental group and the placebo group will be assigned in a 1:1 ratio using a random sequence generated by computer software.

Blinding：

IPD sharing：

No

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

nothing

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

Each selected case must fill in the CRF form. The collection of data and materials is carried out using standard case collection bags and a dedicated person is responsible for inspection and recording. After all cases are collected professional statisticians uniformly complete the collation entry and analysis of data and materials. The EpiData software is used to establish a database. Two people independently enter data at the same time. After that a third person checks and compares the entered data to ensure the accuracy of the entered data. Researchers should keep all research materials including the original cases of all subjects informed consent forms with original signatures all CRFs detailed records of drug distribution question answering forms data modification records adverse reaction records etc. The ownership belongs to the research responsible unit.

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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