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The Mechanism Study of Hua Tuo's Five-Animal Frolics on Immune Inflammation Homeostasis Regulation and Heterotopic Ossification in Ankylosing Spondylitis

Registration number：

ITMCTR2024000756

Date of Last Refreshed on：

2024-11-30

Date of Registration：

2024-11-30

Registration Status：

Prospective registration

Public title：

The Mechanism Study of Hua Tuo's Five-Animal Frolics on Immune Inflammation Homeostasis Regulation and Heterotopic Ossification in Ankylosing Spondylitis

English Acronym：

Scientific title：

The Mechanism Study of Hua Tuo's Five-Animal Frolics on Immune Inflammation Homeostasis Regulation and Heterotopic Ossification in Ankylosing Spondylitis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Pang Lijun

Study leader：

Huang Chuanbin

Applicant telephone：

15178182764

Study leader's telephone：

13865922531

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1114940440@qq.com

Study leader's E-mail：

chuanbinh@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

The Dormitory area of Meishan Road Anhui University of Traditional Chinese Medicine Shushan District Hefei City Anhui Province

Study leader's address：

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine Shushan District Hefei City Anhui Province

Applicant postcode：

230031

Study leader's postcode：

230031

Applicant's institution：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024AH-84

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/9/18 0:00:00

Contact Name of the ethic committee：

Xu Guiqin

Contact Address of the ethic committee：

Scientific Research Department The First Affiliated Hospital of Anhui University of Chinese Medicine No.117 Meishan Road Shushan District Hefei Anhui Province

Contact phone of the ethic committee：

0551 6283 8532

Contact email of the ethic committee：

xuqin608@163.com

Primary sponsor：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Primary sponsor's address：

No. 117 Meishan Road Shushan District Hefei Anhui Province

Secondary sponsor：

Country：

China

Province：

Anhui Province

City：

Hefei City

Institution
hospital：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Address：

No. 117 Meishan Road Shushan District Hefei Anhui Province

Source(s) of funding：

Provincial and ministerial level (Anhui Huatuo Research Institute of Traditional Chinese Medicine science and technology major project "leading the list" project)

Target disease：

Ankylosing spondylitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Huatuo Wuqinxi can improve the mobility of spinal joints in AS patients improve the quality of life and explore the mechanism of anti-heterotopic ossification which may be through the activation of IL-17 NF- κ B / Smad pathway to mediate immune inflammation and regulate heterotopic ossification and participate in the development and development of AS. It is of great significance to improve the progression of spinal rigidity and disease activities in AS patients and improve the quality of life and to make a beneficial exploration of the mechanism of functional exercise in the treatment of AS.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the following diagnostic criteria: AS patients according to the New York criteria for the diagnosis of ankylosing spondylitis revised by the American Society of Rheumatology (ACA) in 1984 and the inflammatory low back pain (IBP) criteria established by the 2009 International Working Group for the Evaluation of spinal arthrosis (ASAS) and the new central axis SpA standard; (2) Age: 18-75 years old; (3) Patients with drugs (except SASP) such as triptrix prednisone (10mg) or other equivalent hormones should be stable for at least one month; (4) Voluntary participation in and actively cooperate with the treatment.

Exclusion criteria：

(1) Do not meet the following diagnostic criteria: AS patients according to the New York diagnostic criteria of ankylosing spondylitis revised by the American Society of Rheumatology (ACA) in 1984 and the inflammatory low back pain (IBP) criteria established by the 2009 International Working Group for Evaluation of spinal arthrosis (ASAS) and the new central axis SpA standard; (2) Combined with serious diseases such as heart liver and kidney and severe extra-articular manifestations; (3) those allergic to the study drug; (4) Advanced patients with severe joint deformity and rigidity and complete loss of joint function; (5) Patients with communication disorders and patients with other diseases.

Study execute time：

From 2024-08-01

To      2025-12-31

Recruiting time：

From 2024-12-01

To      2025-06-01

Interventions：

30

Group：

Study group control group and healthy control group

Sample size：

Intervention：

On the basis of the control group combined with Hua Tuo's Five-Animal Frolics

Intervention code：

30

Group：

Healthy control group

Sample size：

Intervention：

Hua Tuo's Five-Animal Frolics

Intervention code：

30

Group：

Control group

Sample size：

Intervention：

Celecoxib capsules plus sulfasalazine treatment basis

Intervention code：

Total sample size ： 90

Countries of recruitment
and research settings：

Country：

China

Province：

Anhui Province

City：

Institution/hospital：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Level of the institution：

The First Affiliated Hospital of Anhui University of Chinese Medicine

Outcomes：

Outcome：

The expression of IL-17 / NF- κ B and Smad pathway

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Bath Ankylosing Spondylitis Functional Index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Fecal routine

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Bath Ankylosing Spondylitis Disease Activity Index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pillow-Wall Distance

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood routine

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Efficacy evaluation

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

electrocardiogram

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Disease activity

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Magnetic Resonance Imaging and Full Spine X-ray

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Visual Analogue Scale for Patient's Overall Assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

routine urine test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Bath Ankylosing Spondylitis Metrology Index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

liver function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Schober's Test

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

kidney function

Type：

Adverse events

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Others

Note：

Not yet recruiting

18
Min age years
75
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

SAS statistical software was used to obtain the random number table. AS patients were randomly assigned in a ratio of 1:1 to the control group 30 patients in the study group and 30 healthy volunteers for physical examination.

Blinding：

IPD sharing：

No

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

No sharing

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

CRF

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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