UnknownPhase 2/3

Wumeiwan Jiawei Fang Use in Patients With Blepharospasm

China80 participantsStarted 2018-01-12

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: Six months

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

Timeframe: Six months

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

Timeframe: Six months

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

Timeframe: Six months

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

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

Trial details

NCT IDNCT05618470

SponsorChina Academy of Chinese Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

Contact for this trial

wei yang

18600484803 506910548@qq.com

View on ClinicalTrials.gov More Dry Eye Syndromes trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: Six months

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

Timeframe: Six months

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

Timeframe: Six months

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

Timeframe: Six months

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

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