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Dry Eye SyndromesPhase 2/3NCT05618470

Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

A Phase 2/3 study testing Wumeiwan Jiawei Fang and botulinum toxin A in people with Dry Eye Syndromes and Meige Syndrome, run by China Academy of Chinese Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Dry Eye Syndromes, Meige Syndrome, Blepharospasm
What is being tested?
Wumeiwan Jiawei Fang and botulinum toxin A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
12 Jan 2018to 30 Sep 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

wei yang contact

18600484803 ext. 010-68686185

506910548@qq.com

China1 site, 1 recruiting

  • 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

    Xi Chen, 15300307564

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Wumeiwan Jiawei Fang, botulinum toxin A
Keywords
Wumeiwan Jiawei Fang, Blepharospasm, Meige syndrome
Medical subject headings
Dry Eye Syndromes, Meige Syndrome, Blepharospasm, Spasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wumeiwan Jiawei FangDrug

    Also called nothing

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

  • botulinum toxin ADrug

    Also called nothing

    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.

Study groups in NCT05618470
Study groupRoleWhat they receive
Wumeiwan Jiawei FangExperimentalThis group will take Wumei pill granule orally.
Receives: Drug: Wumeiwan Jiawei Fang
botulinum toxin AActive comparatorIn this group, Botulinum toxin type A (Lanzhou Biopharmaceutical Co. LTD.) was injected locally around the eye.
Receives: Drug: botulinum toxin A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Six months

  2. 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.

    Measured: Six months

  3. 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%..

    Measured: Six months

  4. 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.

    Measured: Six months

  5. 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.

    Measured: Six months

  6. 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.

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2022
  2. Study start12 Jan 2018
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05618470
Sponsor's protocol ID
ZZ11-040
Status last verified
Nov 2022
First submitted
21 Oct 2022
Last updated
17 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Wumeiwan Jiawei Fang and botulinum toxin A in people with Dry Eye Syndromes and Meige Syndrome, run by China Academy of Chinese Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact wei yang (18600484803 ext. 010-68686185, 506910548@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The degree of relief of blepharospasm was evaluated by Jankovic Rating Scale. (time frame: Six months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05618470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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