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Clinical and Mechanism Study of Huayu Tongluo Acupuncture Combined with Qutan Fuyuan Ointment in the Treatment of Bell's Facial Paralysis

Registration number：

ITMCTR2024000802

Date of Last Refreshed on：

2024-12-12

Date of Registration：

2024-12-12

Registration Status：

Prospective registration

Public title：

Clinical and Mechanism Study of Huayu Tongluo Acupuncture Combined with Qutan Fuyuan Ointment in the Treatment of Bell's Facial Paralysis

English Acronym：

Scientific title：

Clinical and Mechanism Study of Huayu Tongluo Acupuncture Combined with Qutan Fuyuan Ointment in the Treatment of Bell's Facial Paralysis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Fan Dai

Study leader：

Hongliang Cheng

Applicant telephone：

17805657460

Study leader's telephone：

13013092266

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1172710949@qq.com

Study leader's E-mail：

chl.75811@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Student Apartments of Anhui University of Chinese Medicine Sanli'an Street Shushan District Hefei City Anhui Province

Study leader's address：

No. 300 Shouchun Road Luyang District Hefei City Anhui Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The Second Affiliated Hospital of Anhui University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024-zj-15

Approved file of Ethical Committee：

View

Name of the ethic committee：

The Ethics Committee of the Second Affiliated Hospital of Anhui University of Chinese Medicine

Date of approved by ethic committee：

2024/8/30 0:00:00

Contact Name of the ethic committee：

Yingzi Shu

Contact Address of the ethic committee：

No. 300 Shouchun Road Luyang District Hefei City Anhui Province

Contact phone of the ethic committee：

0551-62668814

Contact email of the ethic committee：

ahzjyykjk@163.com

Primary sponsor：

The Second Affiliated Hospital of Anhui University of Chinese Medicine

Primary sponsor's address：

No. 300 Shouchun Road Luyang District Hefei City Anhui Province

Secondary sponsor：

Country：

China

Province：

AnHui Province

City：

Hefei

Institution
hospital：

The Second Affiliated Hospital of Anhui University of Chinese Medicine

Address：

No. 300 Shouchun Road Luyang District Hefei City Anhui Province

Source(s) of funding：

Anhui University of Traditional Chinese Medicine 2024 in the State Administration of Traditional Chinese Medicine in the field of clinical research project

Target disease：

Bell's paralysis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

(1) To study the effects of Qupalsy Fuyuan ointment combined with Huayu Tongluo drug moxibustion on nerve function recovery nerve edema and prognosis of patients with Bell's facial paralysis in acute stage; (2) Using modern technology to systematically study and evaluate the pharmacodynamics pharmacokinetics safety evaluation and quality control of the prescription of moxibustion for removing stasis and dredging collaterals and Quparalysis compound ointment.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meet the above Bell's traditional Chinese and Western diagnostic criteria for facial paralysis; (2) Unilateral Bell's patients with facial paralysis whose scores were above grade I and below grade VI and whose course of disease did not exceed 14 days according to H-B facial nerve grading scale; Age 15-65 years old male or female; (4) The patient's mental behavior is normal and there are no other serious diseases in the system; ⑤ Signed informed consent voluntarily participated in the study can cooperate with and adhere to the treatment.

Exclusion criteria：

① does not meet Bell's diagnostic criteria for facial paralysis; (2) H-B facial nerve scale score level VI for complete paralysis patients; ③ patients with more than 14 days of illness; ④ Patients with bilateral paralysis; ⑤ Patients with peripheral facial nerve palsy secondary to other diseases such as tumors trauma otitis media etc.; (6) Patients with serious diseases of various organs and mental disorders; ⑦ The experimental compliance may be poor can not complete the experiment; ⑧ Pregnant and lactating women.

Study execute time：

From 2024-05-01

To      2027-05-31

Recruiting time：

From 2024-12-20

To      2025-12-31

Interventions：

80

Group：

Control group

Sample size：

Intervention：

Conventional oral treatment of western medicine

Intervention code：

80

Group：

Treatment group

Sample size：

Intervention：

Huayu Tongluo Yaojiu Combined with Qutan Fuyuan Paste

Intervention code：

Total sample size ： 160

Countries of recruitment
and research settings：

Country：

China

Province：

AnHui Province

City：

Hefei

Institution/hospital：

The Second Affiliated Hospital of Anhui University of Chinese Medicine

Level of the institution：

Class III Class A hospital

Outcomes：

Outcome：

Serum Th17/Treg

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

electromyogram

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Sunnybrook facial nerve evaluation system table

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The expression level of aquaporin 1(AQP1)

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

H-B facial nerve function evaluation grading system evaluation

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Facial Disability Index (FDI) scale

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

15
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The statistical analysis staff of the research group randomly generated the numbers by computer software and grouped them by the test designer according to the size of the numbers with the small number as the control group and the large number as the treatment group

Blinding：

IPD sharing：

Yes

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

ResMan Clinical Trial Public Management Platform "http://www.medresman.org.cn/uc/index.aspx"

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

A Case Record Form (CRF) was used with all CRFS handwritten by the researcher and signed and dated by the chronicler. All traces of CRF revisions were made according to the instructions for filling in the case report form and the case report form was filed by the team leader. Within 2 weeks after all test procedures are completed all test reports and CRF contents shall be checked and the checking personnel and date shall be marked. The case report form and the original data that have been reviewed and signed will be submitted to the data management and the data manager will check and review the date of the case report form enrollment criteria exclusion criteria and shedding criteria one by one. If there is any doubt the researcher will fill in the "data question form" and the researcher will answer and sign another question in the question form in writing and return it to the data manager. The "Data Problem Sheet" shall be kept in good condition.

Data Managemen Committee：

Not yet

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

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