Walnut Shell Glasses Moxibustion for Dry Eye Syndrome

NCT ID: NCT03116776

Last Updated: 2018-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-12-30

Brief Summary

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This trial is designed to evaluate the efficacy of walnut shell glasses moxibustion for dry eye syndrome compared with sodium hyaluronate eye drops.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
outcome assessor and statistician will be blinded

Study Groups

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Walnut Shell Glasses Moxibustion

Use wire to make a glass frame which can fix two walnut shells and moxa roll in front of the eyes, the walnut shell should be soaked in medlar chrysanthemum water and use the moxibustion to treat eye disease.

Group Type EXPERIMENTAL

Walnut Shell Glasses Moxibustion

Intervention Type PROCEDURE

Participants in experimental group will receive 12 sessions of walnut shell glasses moxibustion, each for 30 minutes,3 times per week, and administered over 4 weeks.

Sodium hyaluronate eye drops

Commonly used artificial tears in clinical.

Group Type ACTIVE_COMPARATOR

Sodium hyaluronate eye drops

Intervention Type DRUG

One drop for each eye, four times per day for over 4 weeks.

Interventions

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Walnut Shell Glasses Moxibustion

Participants in experimental group will receive 12 sessions of walnut shell glasses moxibustion, each for 30 minutes,3 times per week, and administered over 4 weeks.

Intervention Type PROCEDURE

Sodium hyaluronate eye drops

One drop for each eye, four times per day for over 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. eyes are in line with dry eye diagnostic criteria.
2. Age 18 to 75 years,
3. signed informed consent, voluntary adherence to treatment for more than 1 month.

Exclusion Criteria

1. combined with other eye disease (such as conjunctiva, cornea and iris have significant lesions).
2. eye surgery within 3 months.
3. pregnant or lactating women.
4. oral the drugs which could inhibit lacrimal gland secretion.
5. severe meibomian gland dysfunction.
6. severe eye burns, chemical injury patients.
7. combined with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental patients.
8. patients with Sjogren's syndrome.
9. patients who are participating in other drug clinical trials.
10. patients who are using other drugs or therapies for the treatment of dry eyes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Weiwei Fu

Postgraduate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiwei Fu

Role: PRINCIPAL_INVESTIGATOR

Department of Acupuncture, Guang' anmen hospital,China Academy of Chinese Medical Science, Beijing(100053), China

Locations

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Guang'anmen Hospital, China Academy of Chinese Medical Sceince

Beijing, Beijing Municipality, China

Site Status RECRUITING

Guang'anmen Hospital, China Academy of Chinese Medical Science

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weiwei Fu

Role: CONTACT

+86-15201309895

Zhishun Liu

Role: CONTACT

+86-10-88001124

Facility Contacts

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Weiwei Fu

Role: primary

+86-15201309895

Zhishun Liu

Role: backup

+86-10-88001124

Weiwei Fu

Role: primary

+86-15201309895

Zhishun Liu

Role: backup

+86-10-88001124

Other Identifiers

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2016-121-KY-01

Identifier Type: -

Identifier Source: org_study_id

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