Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

NCT ID: NCT05618470

Last Updated: 2022-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2024-09-30

Brief Summary

To evaluate the efficacy and safety of Jing Fang Wu Mei Wan Jiawei Fang in the treatment of idiopathic blepharospasm using a clinical randomized controlled trial method.

Detailed Description

Idiopathic blepharospasm is an idiopathic dysfunction characterized by involuntary spasms of the eyelids bilaterally that interfere with visual function and cause ocular discomfort. The incidence has increased each year in recent years, and the disease may present with persistent eye closure or even functional blindness in advanced stages. In some patients, the disease may be associated with submandibular dystonia, known as Meige's syndrome. Currently, the disease is treated symptomatically. Such as oral.These treatments not only have large side effects, but also make it difficult to relieve the patient of multiple lesions in the eyes, face and tongue. Chinese medicine has unique advantages in treating this disease, highlighting the overall diagnosis and solving different parts of the disease in an integrated manner. Wu Mei Wan is a traditional Chinese medicine prescription, and our team has been using Wu Mei Wan Jia Wei Fang for the treatment of Meige syndrome since 2009 under the leadership of Gao Jiansheng, a famous Chinese medicine teacher in the capital, and found significant therapeutic effects in preliminary clinical observation, but there is a lack of large sample of randomized controlled clinical studies. In this study, we propose to systematically observe the efficacy of traditional Chinese medicine in the treatment of idiopathic blepharospasm by using the traditional sutra formula for idiopathic blepharospasm as a test group and local botulinum toxin A injection as a control group, and to scientifically evaluate the efficacy of the Wu Mei Wan Jia Wei Fang in the treatment of idiopathic blepharospasm.The results were evaluated in order to provide new treatment options for the clinical management of idiopathic blepharospasm (including Meige syndrome) and to benefit more patients.

Conditions

Dry Eye Syndromes; Meige Syndrome; Blepharospasm; Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Wumeiwan Jiawei Fang

This group will take Wumei pill granule orally.

Group Type: EXPERIMENTAL

Wumeiwan Jiawei Fang

Intervention Type: DRUG

orally administered Wumeiwan Jiawei Fang prescription granules, 1 dose a day, twice a day, once for 14 days, for 42 days.

botulinum toxin A

In this group, Botulinum toxin type A (Lanzhou Biopharmaceutical Co. LTD.) was injected locally around the eye.

Group Type: ACTIVE_COMPARATOR

botulinum toxin A

Intervention Type: DRUG

Botulinum toxin (Lanzhou Biopharmaceutical Co., LTD.) was injected into the medial side of the upper eyelid, the lateral side of the upper eyelid, the lateral side of the lower eyelid, and the temporal orbicularis oculi muscle of the lateral canthus. The botulinum toxin type A was diluted into 50IU/ML with normal saline and injected with a 1ml skin test syringe (4\\ 5-gauge needle), and 2.5IU was injected into each point. A total of 1 injection.

Interventions

Wumeiwan Jiawei Fang

orally administered Wumeiwan Jiawei Fang prescription granules, 1 dose a day, twice a day, once for 14 days, for 42 days.

Intervention Type: DRUG

botulinum toxin A

Botulinum toxin (Lanzhou Biopharmaceutical Co., LTD.) was injected into the medial side of the upper eyelid, the lateral side of the upper eyelid, the lateral side of the lower eyelid, and the temporal orbicularis oculi muscle of the lateral canthus. The botulinum toxin type A was diluted into 50IU/ML with normal saline and injected with a 1ml skin test syringe (4\\ 5-gauge needle), and 2.5IU was injected into each point. A total of 1 injection.

Intervention Type: DRUG

Other Intervention Names

nothing; nothing

Eligibility Criteria

Inclusion Criteria

1. Idiopathic blepharospasm met the diagnostic criteria.

2. The age ranges from 18 to 80 years.

3. Liver Yang deficiency,mixed syndrome of cold and heat.

4. Signed Informed consent

Exclusion Criteria

1. Secondary blepharospasm due to keratoconjunctivitis, trichiasis, and blepharitis.

2. Open eyelid disuse.

3. hemifacial spasm.

4. The patient had undergone eye surgery in the previous 6 months.

5. Allergic to the ingredients in the medicine.

6. Corneal lenses were worn during the study.

7. A woman who is pregnant or breastfeeding.

8. Combined with cardiovascular, cerebrovascular,Liver and kidney function, hematopoietic system serious primary disease, mental patients, combined with stroke patients.

9. At the same time, use drugs that interfere with the evaluation of drug efficacy.

10. Idiopathic blepharospasm is treated with other drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Yang Wei

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

wei yang

Role: PRINCIPAL_INVESTIGATOR

China Academy of Chinese Medical Sciences

Locations

Eye Hospital, China Academy of Chinese Medical Sciences；GuangAnmen Hospital, China Academy of Chinese Medical Sciences；XiYuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

wei yang

Role: CONTACT

506910548@qq.com

18600484803 ext. 010-68686185

Facility Contacts

Xi Chen

Role: primary

15300307564

Other Identifiers

ZZ11-040

Identifier Type: -

Identifier Source: org_study_id