Clinical trial NCT05618470: Wumeiwan Jiawei Fang Use in Patients With Blepharospasm
Official title: Randomized Controlled Clinical Study on Wumeiwan Jiawei Fang Use in Patients With Blepharospasm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndromes
Meige Syndrome
Blepharospasm
Hyperactivity
Keywords: Wumeiwan Jiawei Fang
Blepharospasm
Meige syndrome
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The degree of relief of blepharospasm was evaluated by Jankovic Rating Scale.
timeFrame: Six months
measure: The Blepharospasm Disability Index (BSDI) was used to evaluate the impact of blepharospasm on daily living activities before and after treatment.
timeFrame: Six months
measure: Traditional Chinese Medicine（TCM） syndrome scale evaluated the change of systemic syndrome before and after treatment.
timeFrame: Six months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Six months
measure: According to the Jankovic rating scale, the recurrence was determined at 14 days, 42 days, 3 months and 6 months after medication
timeFrame: Six months
measure: Number of participants with treatment-related adverse events as assessed by systemic response, routine blood tests, liver function (ALT), kidney function (BUN, Cr).
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Eye Hospital, China Academy of Chinese Medical Sciences；GuangAnmen Hospital, China Academy of Chinese Medical Sciences；XiYuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: wei yang
role: PRINCIPAL_INVESTIGATOR
References: