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A randomized controlled clinical study of intranasal acupuncture for allergic conjunctivitis

Registration number：

ITMCTR2024000365

Date of Last Refreshed on：

2024-09-03

Date of Registration：

2024-09-03

Registration Status：

Retrospective registration

Public title：

A randomized controlled clinical study of intranasal acupuncture for allergic conjunctivitis

English Acronym：

Scientific title：

A randomized controlled clinical study of intranasal acupuncture for allergic conjunctivitis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

YanYixian

Study leader：

DuJinyu

Applicant telephone：

15506943006

Study leader's telephone：

18390952090

Applicant Fax：

Study leader's fax：

Applicant E-mail：

15506943006@163.com

Study leader's E-mail：

946543194@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Dongzhimen Hospital Beijing University of Chinese Medicine No. 5 Haiyuncang Dongcheng District Beijing China

Study leader's address：

Department of Ophthalmology Dongzhimen Hospital Beijing University of Traditional Chinese Medicine No. 116 Cuiping West Road Tongzhou District Beijing China

Applicant postcode：

100700

Study leader's postcode：

Applicant's institution：

Dongzhimen Hospital Beijing University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2023DZMEC-537-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee Dongzhimen Hospital Beijing University of Chinese Medicine China

Date of approved by ethic committee：

2024/1/8 0:00:00

Contact Name of the ethic committee：

HanXueting

Contact Address of the ethic committee：

Dongzhimen Hospital Beijing University of Chinese Medicine No. 5 Haiyuncang Dongcheng District Beijing China

Contact phone of the ethic committee：

18101127292

Contact email of the ethic committee：

dzmyyec@126.com

Primary sponsor：

Dongzhimen Hospital Beijing University of Chinese Medicine China

Primary sponsor's address：

Dongzhimen Hospital Beijing University of Chinese Medicine No. 5 Haiyuncang Dongcheng District Beijing China

Secondary sponsor：

Country：

china

Province：

beijing

City：

Institution
hospital：

Dongzhimen Hospital of Beijing University of Chinese Medicine

Address：

Dongzhimen Hospital Beijing University of Chinese Medicine No. 5 Haiyuncang Dongcheng District Beijing China

Source(s) of funding：

Beijing University of Traditional Chinese Medicine New Faculty Fund for FY2023

Target disease：

allergic conjunctivitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

The purpose of this study was to evaluate the clinical efficacy of intranasal needle in the treatment of allergic conjunctivitis and patient-related indexes. In order to clarify the therapeutic role of intranasal needle in allergic conjunctivitis so as to innovate the therapeutic method of allergic conjunctivitis and provide easier and more effective treatment for clinical patients.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Meet the clinical diagnostic criteria for allergic conjunctivitis and be 18-70 years of age; (2) Being in an episode of conjunctivitis; (3) Subjects voluntarily accept the appropriate trial protocol accept timely follow-up and sign an informed consent form.

Exclusion criteria：

(1) Concomitant ocular surface diseases such as infectious conjunctivitis drug-induced conjunctivitis autoimmune keratoconjunctivitis and bacterial conjunctivitis; (2) Systemic or topical ophthalmic use within 1 week prior to treatment that may interfere with the evaluation of the drug's effects; (3) Pregnant or lactating women; (4) Patients who are unable to stop wearing corneal contact lenses during treatment and observation; (5) Patients with mental disorders or those who are unable to communicate normally; (6) Patients with combined hepatic or renal insufficiency immune-related diseases or life-threatening systemic diseases; (7) Those who have taken herbal preparations that can cause allergic rhinitis within 14 days or have contraindications to needling.

Study execute time：

From 2024-01-08

To      2025-01-08

Recruiting time：

From 2024-01-08

To      2025-01-08

Interventions：

35

Group：

Western medicine group

Sample size：

Intervention：

Potassium pyrimethamine eye drops combined with fluticasone eye drops

Intervention code：

35

Group：

Acupuncture-medicine combination group

Sample size：

Intervention：

intranasal needling combined with pyrimethamine potassium eye drops

Intervention code：

Total sample size ： 70

Countries of recruitment
and research settings：

Country：

china

Province：

beijing

City：

Institution/hospital：

Dongzhimen Hospital of Beijing University of Chinese Medicine

Level of the institution：

Class A tertiary hospital

Outcomes：

Outcome：

blood IgE antibody

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 2 weeks after completion of treatment

Measure method：

Outcome：

Eye Symptom Score

Type：

Primary indicator

Measure time point of outcome：

Before treatment, 1 week of treatment, 2 weeks of treatment, 2 weeks after completion of treatment

Measure method：

Ocular symptoms were scored according to the degree of manifestation, with the exception of eye itch, which was scored 0, 3, 6, and 9, respectively, from mild to severe, and the rest of the symptoms were scored 0-3 according to severity. The scoring criteria are described in the literature. The scores of all items were summed up to obtain the ocular symptom score. Symptoms were scored according to the literature.

Outcome：

Conjunctival scraping cytology

Type：

Additional indicator

Measure time point of outcome：

Before treatment 1 week of treatment 2 weeks of treatment 2 weeks after completion of treatment

Measure method：

Outcome：

Scoring of ocular signs

Type：

Primary indicator

Measure time point of outcome：

Before treatment 1 week of treatment 2 weeks of treatment 2 weeks after completion of treatment

Measure method：

The researchers observed the ocular signs under a slit lamp microscope. All signs were scored 0-3 according to severity except for conjunctival congestion which was scored 0 3 6 and 9 respectively from mild to severe. The scores of all items were added together to obtain the ocular sign score. Signs were scored according to the literature.

Outcome：

Tear IgE

Type：

Secondary indicator

Measure time point of outcome：

Before treatment 1 week of treatment 2 weeks of treatment 2 weeks after completion of treatment

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Tear

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

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)：

Generation of random number series by other researchers using a random number table

Blinding：

Single-blind concealed grouping of investigator evaluators

IPD sharing：

No

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

unshared

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

(1) Completion of the CRF including possible adverse events and treatment measures: excessive nosebleed etc. The investigator completes the case report form in a timely complete correct and legible manner based on the subject's hospitalization history and original observation record. (2) Verify that the CRF surveillance trial followed the trial protocol. Confirm that all case report forms are filled out correctly and completely and are consistent with the original information. If there are errors or omissions ask the investigator to make corrections in a timely manner. Corrections should be made in such a way that the original records are legible and the corrections should be signed and dated by the investigator. (3) Retrieval of the CRF A special record should be kept of the transmission of the completed CRF between the investigator and the data manager with appropriate signatures on receipt and the record should be kept appropriately.

Data Managemen Committee：

No

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

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