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Efficacy and safety of topical usage of frankincense essential oil for patients with idiopathic blepharospasm

Efficacy and safety of topical usage of frankincense essential oil for patients with idiopathic blepharospasm

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091834
Enrollment
Unknown
Registered
2024-11-05
Start date
2024-11-10
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

idiopathic blepharospasm (iBSP)

Interventions

Topical frankincense essential oil (FEO) group:The FEO are diluted in a 1:1 ratio of 100% pure frankincense essential oil to 100% pure coconut oil. Participants will begin applying the FEO mixture to

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 iBSP by 2 specialists according to the diagnostic criteria; (2) Age 18-70 years old; (3) Disease duration < 10 years; (4) Jankovic Rating Scale (JRS) frequency sub-scale score = 3 points; (5) Newly diagnosed patients who have not received any treatment and are unwilling to receive oral medications and invasive treatments such as botulinum toxin injections; (6) have received oral drug therapy in the past, but the therapeutic effect is not satisfied or the drug side effects are not tolerated and are unwilling to accept invasive treatment such as botulinum toxin injection; (7) All candidates signed informed consent voluntarily.

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) Patients who are contraindicated for MRI examination by implanting metal or electronic devices such as cardiac pacemakers or artery clips in the body; (7) T2-weighted or Flair imaging found white matter signal abnormalities of grade 2 or above (grade 1 = scattered punctate lesions; Grade 2 = fusion lesions; Level 3 = large fusion area); (8) Participants in other clinical trials within the last 3 months.

Design outcomes

Primary

MeasureTime frame
Effectiveness in relieving motor symptoms when subjects received topical FEO for 3 months.;

Secondary

MeasureTime frame
Improvement rate of motor symptom score after receiving topical frankincense essential oil;Improvement rate of subjects' quality of life after topical FEO;Subjective efficacy evaluation after topical FEO;Incidence of adverse reactions in subjects after topical FEO;

Countries

China

Contacts

Public ContactGang Liu

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