NCT05618470

Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

Randomized Controlled Clinical Study on Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2018-01-12
• Primary completion: 2024-08-30
• Completion: 2024-09-30
• First posted: 2022-11-16
• Last updated: 2022-11-17

Locations

1 site across 1 country: China