Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

China Academy of Chinese Medical Sciences

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Hyperactivity; Blepharospasm; Meige Syndrome; Dry Eye Syndromes

Treatments: Drug: botulinum toxin A; Drug: Wumeiwan Jiawei Fang

Study type: Interventional

Funder types: Other

Identifiers

NCT05618470

ZZ11-040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Wumeiwan Jiawei Fang

Experimental group

Description:

This group will take Wumei pill granule orally.

Treatment:

Drug: Wumeiwan Jiawei Fang

botulinum toxin A

Active Comparator group

Description:

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

Treatment:

Drug: botulinum toxin A