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A randomized positive drug-controlled clinical trial of the efficacy and safety of KHN129 Chuanjiaofang Linfang Granules in the treatment of allergic conjunctivitis (wind-heat syndrome).

Registration number：

ITMCTR2024000612

Date of Last Refreshed on：

2024-10-27

Date of Registration：

2024-10-27

Registration Status：

Retrospective registration

Public title：

A randomized positive drug-controlled clinical trial of the efficacy and safety of KHN129 Chuanjiaofang Linfang Granules in the treatment of allergic conjunctivitis (wind-heat syndrome).

English Acronym：

Scientific title：

A randomized positive drug-controlled clinical trial of the efficacy and safety of KHN129 Chuanjiaofang Linfang Granules(Qinjiao granules) in the treatment of allergic conjunctivitis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Yanlin Zheng

Study leader：

Yanlin Zheng

Applicant telephone：

+8618227648953

Study leader's telephone：

+8618227648953

Applicant Fax：

Study leader's fax：

Applicant E-mail：

zyl3327@163.com

Study leader's E-mail：

zyl3327@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 39 Twelve Bridges Road Jinniu District Chengdu City Sichuan Province China 610075

Study leader's address：

No. 39 Twelve Bridges Road Jinniu District Chengdu City Sichuan Province China 610075

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Hospital of Chengdu University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024KL-130

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/9/5 0:00:00

Contact Name of the ethic committee：

Xitao Ma

Contact Address of the ethic committee：

No. 39 Twelve Bridges Road Jinniu District Chengdu City Sichuan Province

Contact phone of the ethic committee：

+86 28 8778 3142

Contact email of the ethic committee：

ethicscd@126.com

Primary sponsor：

Hospital of Chengdu University of Traditional Chinese Medicine

Primary sponsor's address：

No. 39 Twelve Bridges Road Jinniu District Chengdu City Sichuan Province

Secondary sponsor：

Country：

China

Province：

Sichuan

City：

Chengdu

Institution
hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Address：

No. 39 Twelve Bridges Road Jinniu District Chengdu City Sichuan Province

Source(s) of funding：

self-financing

Target disease：

allergic conjunctivitis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

To evaluate the efficacy and safety of Qinjiao granules in the treatment of allergic conjunctivitis

Description for medicine or protocol of treatment in detail：

Ingredients: Scutellaria baicalensis ;Pricklyash Peel;Schisandra chinensis ;Angelica dahurica ;Hypericum perforatum l.;Rhizoma chuanxiong;madder

Inclusion criteria

(1)Understand and sign the informed consent form approved by the Ethics Committee; (2)Age 12~65 years old male or female; (3)Within 1 week prior to obtaining informed consent have any of the following signs of allergies:a)Positive blood or tear IgE antibody test b)Eosinophils are found on conjunctival scraping; (4)At the time of informed consent and baseline the following criteria should be met for eye itching:c)Itchy eye self-rating in either eye ≥ 7 points. And the following signs: conjunctival injection conjunctival papilla cornea-specific lesion characteristics at least 1 investigator score ≥ 1 point (all scores: 0~3 points). (5)TCM syndrome differentiation is a wind-heat syndrome. (6)Willing and able to comply with the examinations and observations specified in the trial protocol.

Exclusion criteria：

(1)Pregnant or lactating women. (2)Accompanied by ocular diseases other than allergic conjunctivitis that affect the efficacy and safety evaluation including but not limited to trauma requiring treatment drug-induced keratitis blepharitis follicular conjunctivitis dry eye glaucoma cornea iris anterior chamber active inflammation and/or substantial structural changes etc.; (3)The standard eye chart measures best-corrected visual acuity < 0.1 in either eye; (4)Weight < 35kg; (5)Concomitant active ocular infections (viral bacterial fungal protozoa) or a history of ocular herpes; (6)Concomitant retinal detachment diabetic retinopathy or any prior history of progressive retinal disease or with retinal disease that is likely to progress during the trial; (7)Have ocular disease other than allergic conjunctivitis that requires ocular topical treatment (including artificial tear preparations) during the trial period; (8)Require or plan to wear contact lenses (including orthokeratology lenses) for the duration of the t

Study execute time：

From 2024-09-26

To      2025-06-30

Recruiting time：

From 2024-09-26

To      2025-05-31

Interventions：

36

Group：

Olopatadine hydrochloride group

Sample size：

Intervention：

Olopatadine hydrochloride eye drops, 2 times a day, 1~2 drops/time, with an interval of more than 6-8 hours, for 2 weeks.

Intervention code：

36

Group：

Combination drug group

Sample size：

Intervention：

According to the above two groups of drug regimens, olopatadine hydrochloride and Qinjiao granules were used at the same time.

Intervention code：

36

Group：

Experimental group

Sample size：

Intervention：

Take Qinjiao granules 2 sachets 1 time after meals 2 times a day for 2 weeks.

Intervention code：

Total sample size ： 108

Countries of recruitment
and research settings：

Country：

China

Province：

Sichuan

City：

Institution/hospital：

Leshan Traditional Chinese Medicine Hospital(Leshan Hospital of Chengdu University of Traditional Chinese Medicine)

Level of the institution：

Tertiary A

Country：

China

Province：

Sichuan

City：

Institution/hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

The maximum eye itch score within 24 hours before the visit on the 8th and 15th days, and the change value on the 8th day compared with baseline;

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The change value of the maximum eye itch score from baseline in the 24 hours before the visit on the 15th day

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The maximum self rating of various eye symptoms (eye secretions, tears, and foreign body sensation) within 24 hours before the 8th and 15th day visits to the hospital, as well as the changes compared to baseline

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The total investigator scores for eye signs (eyelid conjunctiva, conjunctiva (including conjunctival congestion), corneal margin, cornea) on the 8th and 15th day of hospital visits, as well as the changes compared to baseline

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Rhinoconjunctivitis Quality of Life Questionnaire（RQLQ scale）

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM Syndrome Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The bulbar conjunctival hyperemia score at the visit on day 8 and day 15, and the change value from baseline on day 8;

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The change in the score of bulbar conjunctival hyperemia compared with baseline at the visit on the 15th day

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Eye exam

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The sum of the maximum self ratings of eye symptoms (such as itching, eye discharge, tearing, and foreign body sensation) within 24 hours before the 8th and 15th day visits to the hospital, as well as the changes compared to baseline

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

On the 8th and 15th day of the hospital visit, the researcher's scores for various ocular signs (eyelid conjunctiva, conjunctiva (excluding conjunctival congestion), corneal margin, and cornea), as well as the changes compared to baseline, were evaluated

Type：

Secondary indicator

Measure time point of outcome：

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

12
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)：

This trial adopts the block randomization method and the randomization statistician uses professional statistical software to make a random number table and given the number of seeds a random table of subjects will be generated according to the ratio of 1:1:1.

Blinding：

randomized and unblinded label

IPD sharing：

No

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

None

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

CRF

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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