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Efficacy and safety of topical frankincense essential oil with botulinum toxin injection for blepharospasm: an open-label randomized controlled study

Efficacy and safety of topical frankincense essential oil with botulinum toxin injection for blepharospasm: an open-label randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091987
Enrollment
Unknown
Registered
2024-11-07
Start date
2024-11-10
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blepharospasm

Interventions

BoNT-A injection associated with FEO group:BoNT-A injection associated with FEO
BoNT-A injection associated with coconut oil group:BoNT-A injection associated with coconut oil

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as idiopathic BSP iBSP. by 2 movement disorder specialists according to the diagnostic criteria; 2. The effective maintenance time of 3 rounds of BoNT-A injection therapy or 1 round of treatment by experienced BoNT-A injection experts was <3 months; 3. Aged 18-70 years old; 4. Jankovic Rating Scale JRS. frequency sub-scale scores are equal to or greater than 3 points; 5. Patients were randomly assigned at least 12 weeks after the last botulinum toxin injection.; 6. All candidates signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with family history or diagnosis of hereditary dystonia, acquired dystonia, tardive dyskinesia, or functional dyskinesia; 2. Patients with acute intracranial diseases such as stroke, intracranial infection, etc.., or have a history of psychiatric diseases, dementia, epilepsy, multiple sclerosis, Tourette's disease, Parkinson's disease or Parkinson's syndrome, severe craniocerebral trauma and other neurological diseases; 3. Patients with severe systemic diseases that significantly shorten life expectancy; 4. Patients with obvious anxiety or depression, in which Hamilton Anxiety Scale HAMA. -14 and/or Hamilton Depression Scale HAMD. -17 scores are more than 14 points; 5. Patients with cognitive decline, in which Minimum Mental State Examination MMSE. is less than 24 points; 6. Participants in other clinical trials within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Maintenance time of effective improvement of clinical symptoms during the observation period of 6 months after receiving topical FEO associated with BoNT-A.;

Secondary

MeasureTime frame
The interval time when subjects receive BoNT-A injection again.;Improvement rate of motor symptom severity in subjects treated with topical frankincense essential oil with botulinum toxin injection.;Improvement rate for quality of life in subjects treated with topical frankincense essential oil with BoNT-A injection.;Subjective efficacy evaluation of subjects treated with topical frankincense essential oil with BoNT-A injection.;

Countries

China

Contacts

Public ContactLiu Gang

The First Affiliated Hospital of Sun Yat-sen University

liug26@mail.sysu.edu.cn+86 186 6467 8483

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026