Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

NCT05618470 | Unknown Phase 2

• 1 other identifier: ZZ11-040
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes; Meige Syndrome; Blepharospasm; Hyperactivity

Keywords

Wumeiwan Jiawei Fang; Blepharospasm; Meige syndrome

Outcome Measures

Primary Outcomes (6)

• The degree of relief of blepharospasm was evaluated by Jankovic Rating Scale.

  According to the Jankovic Rating Scale (JRS), in terms of severity and frequency, the score ranges from 0 to 4, with the highest score being 8. The higher the score is, the more severe the spasm is.

  Six months

• The Blepharospasm Disability Index (BSDI) was used to evaluate the impact of blepharospasm on daily living activities before and after treatment.

  A total of 6 items were included, including walking, reading, driving, shopping, watching television and general activities. Each item was scored from 0 to 4 points and was self-evaluated by the patients. The total score of BSDI was 24 points.The higher the score is, the more severe the spasm is.

  Six months

• Traditional Chinese Medicine（TCM） syndrome scale evaluated the change of systemic syndrome before and after treatment.

  The score for each syndrome is the sum of the highest scores obtained for each diagnosis of the syndrome. The full score is 30 points. Efficacy score = (Total score of pre-treatment symptoms➖Total post-treatment symptom score)/Total score of pre-treatment symptoms×100%. Symptoms basically disappear, reducing by 95 to 100 percent; Obvious effect: symptoms decreased significantly, reaching more than 75%; Effective: symptoms decreased to more than 55%; Ineffective: No or slightly reduced symptoms, only less than 50%..

  Six months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  According to whether there are common side effects of botulinum toxin such as ptosis, diplopia, photophobia, dry eye, gastrointestinal tract of exposed keratitis, whether there are gastrointestinal reactions and other side effects that may be related to the Chinese medicine granule preparation in this study.

  Six months

• According to the Jankovic rating scale, the recurrence was determined at 14 days, 42 days, 3 months and 6 months after medication

  According to the Jankovic rating scale, the recurrence situation at 14 days, 42 days, 3 months and 6 months after medication was determined, and the increase of spasm intensity by 1 grade or more was considered as recurrence.

  Six months

• Number of participants with treatment-related adverse events as assessed by systemic response, routine blood tests, liver function (ALT), kidney function (BUN, Cr).

  1. Systemic reaction (record at any time); 2. Routine blood tests: the detection points were 14 days, 42 days, 3 months and 6 months after the first visit and treatment; 3. Liver function (ALT), kidney function (BUN, Cr) : The detection points were 14 days, 42 days, three months and six months after the first visit and treatment.

  Six months

Study Arms (2)

Wumeiwan Jiawei Fang

EXPERIMENTAL

This group will take Wumei pill granule orally.

Drug: Wumeiwan Jiawei Fang

botulinum toxin A

ACTIVE COMPARATOR

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

Drug: botulinum toxin A

Interventions

Wumeiwan Jiawei Fang DRUG

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

Also known as: nothing

Wumeiwan Jiawei Fang

botulinum toxin A 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.

Also known as: nothing

botulinum toxin A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Idiopathic blepharospasm met the diagnostic criteria.
• The age ranges from 18 to 80 years.
• Liver Yang deficiency,mixed syndrome of cold and heat.
• Signed Informed consent

You may not qualify if:

• Secondary blepharospasm due to keratoconjunctivitis, trichiasis, and blepharitis.
• Open eyelid disuse.
• hemifacial spasm.
• The patient had undergone eye surgery in the previous 6 months.
• Allergic to the ingredients in the medicine.
• Corneal lenses were worn during the study.
• A woman who is pregnant or breastfeeding.
• Combined with cardiovascular, cerebrovascular,Liver and kidney function, hematopoietic system serious primary disease, mental patients, combined with stroke patients.
• At the same time, use drugs that interfere with the evaluation of drug efficacy.
• Idiopathic blepharospasm is treated with other drugs.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (1)

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, 10040, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Meige Syndrome; Blepharospasm; Spasm

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dystonic Disorders; Movement Disorders; Eyelid Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• wei yang

  China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wei yang

CONTACT

18600484803; 506910548@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 16, 2022
• Study Start: January 12, 2018
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

CN (1)