Dry Eye Syndromes Clinical Trial
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | 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 |
Lead Sponsor | Collaborator |
---|---|
China Academy of Chinese Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 symptomsĂ—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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Number of participants with treatment-related adverse events as assessed by systemic response, routine blood tests, liver function (ALT), kidney function (BUN, Cr). | Systemic reaction (record at any time);
Routine blood tests: the detection points were 14 days, 42 days, 3 months and 6 months after the first visit and treatment; 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04425551 -
Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction
|
N/A | |
Not yet recruiting |
NCT06379685 -
Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface.
|
Phase 1 | |
Recruiting |
NCT04701086 -
3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
|
N/A | |
Active, not recruiting |
NCT03697876 -
Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel
|
Phase 1 | |
Completed |
NCT02910713 -
Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation
|
N/A | |
Terminated |
NCT02815293 -
Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye
|
Phase 3 | |
Completed |
NCT04104997 -
A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers
|
Phase 1 | |
Recruiting |
NCT02595606 -
0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients
|
Phase 4 | |
Completed |
NCT01711424 -
An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease
|
N/A | |
Completed |
NCT01015209 -
Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
|
Phase 1 | |
Completed |
NCT01202747 -
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction
|
Phase 2/Phase 3 | |
Completed |
NCT00969280 -
Acupuncture for Dry Eye Syndrome
|
Phase 3 | |
Completed |
NCT01496482 -
Comparison of Evaporimetry With the Established Methods of Tear Film Measurement
|
N/A | |
Completed |
NCT00739713 -
Effects of Sea Buckthorn Oil on Dry Eye
|
N/A | |
Completed |
NCT00756678 -
Efficacy and Acceptability of Two Lubricant Eye Drops
|
Phase 4 | |
Completed |
NCT00349440 -
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
|
Phase 4 | |
Completed |
NCT00370747 -
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
|
Phase 2 | |
Completed |
NCT05162261 -
to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction
|
N/A | |
Completed |
NCT02871440 -
A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye
|
Phase 3 | |
Completed |
NCT05042960 -
Computer Screen Properties Study
|
N/A |