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A clinical study of Huang-Lian-Jie-Du Decoction on Kgp, RgpB and inflammatory factors in chronic periodontitis caused by Porphyromonas gingivalis.

Registration number：

ITMCTR2200006772

Date of Last Refreshed on：

2022-11-13

Date of Registration：

2022-11-13

Registration Status：

Prospective registration

Public title：

A clinical study of Huang-Lian-Jie-Du Decoction on Kgp, RgpB and inflammatory factors in chronic periodontitis caused by Porphyromonas gingivalis.

English Acronym：

Scientific title：

Research on a new mechanism of Huang-lian-Jie-du Decoction's inhibition of gingipains to regulate

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200065708 ; ChiMCTR2200006772

Applicant：

Yue Zhu

Study leader：

Weiping Zhao

Applicant telephone：

18215518606

Study leader's telephone：

08252292604

Applicant Fax：

Study leader's fax：

Applicant E-mail：

cathyzhuyue@163.com

Study leader's E-mail：

1539537346@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 39, Shierqiao Road, Jinniu District, Chengdu City, Sichuan Province

Study leader's address：

No.127 Desheng West Road, Chuanshan District, Suining City, Sichuan Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

LLSLH20220024

Approved file of Ethical Committee：

View

Name of the ethic committee：

Suining Central Hospital Medical Research Ethics Committee

Date of approved by ethic committee：

2022/6/8 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Suining Central Hospital

Primary sponsor's address：

No.127 Desheng West Road, Chuanshan District, Suining City, Sichuan Province

Secondary sponsor：

Country：

Chinese

Province：

Si Chuan

City：

Institution
hospital：

Suining Central Hospital

Address：

No. 127 Desheng West Road, Chuanshan District, Suining City, Sichuan Province

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Chronic periodontitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

The primary objective of this study is to evaluate the efficacy of HLJDD in the treatment of chronic periodontitis. Secondly, the researchers intend to evaluate whether HLJDD can treat chronic periodontitis by inhibiting P.g and the gingipains Kgp and RgpB. Finally, the safety of this herbal formulation will be assessed.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. The subject signs the informed consent form and is willing to be tested. The process of obtaining informed consent should comply with Good Clinical Practice regulations. 2. Aged 18–65 years, meets the diagnostic criteria of Western medicine for mild to moderate chronic periodontitis and meets the TCM criteria for syndrome differentiation of stomach fire flaring gum. 3. At least 20 teeth in the whole mouth that can be evaluated for periodontal assessment. 4. No history of smoking. 5. Medical history and results of physical examination within 1 year will be requested. There is no history of systemic disease, immune-related disease or orthodontic treatment. 6. No use of immunosuppressive drugs within 3 months. 7. Women are not pregnant or breastfeeding. 8. No periodontal treatment within 6 months. 9. No use of antibiotics or non-steroidal anti-inflammatory drugs within 2 weeks. 10. No long-term use of drugs that cause gingival hyperplasia or interfere with the recovery of periodontal tissue.

Exclusion criteria：

He or she: 1. Is under 18 years old or over 65 years old. 2. Has severe heart, liver, lung or kidney damage. 3. Is infected in other areas or suffering from an immune disease. 4. Is a lactating or pregnant woman. 5. Is undergoing orthodontic treatment or wearing removable partial dentures. 6. Suffers from complications such as gingival hyperplasia, periodontal abscess, retrograde pulpitis, secondary occlusal trauma or concomitant oral mucosal disease. 7. Is currently participating in another clinical trial or receiving another related treatment that can affect the observed indicators. 8. Is completely unwilling to communicate and cooperate, mentally abnormal or unwilling to sign the informed consent form.

Study execute time：

From 2022-11-15

To      2023-11-15

Recruiting time：

From 2022-11-15

To      2023-08-01

Interventions：

33

Group：

Control group

Sample size：

Intervention：

periodontal basic treatment +Chlorhexidine mouthwash

Intervention code：

33

Group：

HLJDD group

Sample size：

Intervention：

periodontal basic treatment +gargling and oral administration of Huang-Lian-Jie-Du Decoction

Intervention code：

Total sample size ： 66

Countries of recruitment
and research settings：

Country：

China

Province：

Si Chuan

City：

Institution/hospital：

Suining central hospital

Level of the institution：

Grade A tertiary hospital

Outcomes：

Outcome：

TNF-α

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

CRP

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-10

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Clinical curative effect

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-1β

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-8

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

lysine-specific gingipain (Kgp)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

IL-6

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Porphyromonas gingivalis

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

arginine-specific gingipain (Rgp)

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

gingival crevicular fluid

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
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)：

Spss software was used to randomize groups and determine the group sequence, and the personnel who determined the group and sequence did not participate in the inclusion of cases. The inclusion of cases will be completed by the stomatologists of Suining Central Hospital, and the allocation table will be&#32

Blinding：

IPD sharing：

No

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

No

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

All data of enrolled patients will be recorded in the CRF form, and all data will be entered and stored on a secure server and copied on hard disk.

Data Managemen Committee：

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

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