The randomized double-blinded controlled trial of Kparviflora versus Betahistine in treating chronic vertigenous patients

Phase 2

Completed

• Conditions: chronic vertigochronic dizziness; vertigo; dizziness; chronic vertigo

• Registration Number: TCTR20220829001
• Lead Sponsor: Argricultural Research Development Agency (Public Organization)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-29
• Study Completion: 2024-03-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Individual who suffered from chronic dizziness longer than 1 month with DHI-T score over 18
2. Age 18-75 years
3. Individual who are willing and able to comply with protocol until the end of project
4. Able to read and write in Thai

Exclusion Criteria

1. Individual who had been diagnosed with Benign Paroxysmal Positional Vertigo or Vestibular Migraine or Height Vertigo or Orthostatic Hypotension or Mental or psychiatric problem
2. Individual with abnormal proprioception including tremor and hemiplegia paraplegia
3. Individual with cardiac arrythmia
4. Individual who had been treated with and cannot withdraw EGb761 120mg/day or over or Betahistine 36 mg/day or over for longer than 72 hours
5. Individual who currently consume other herbal medicines
6. Individual who currently consume any kind of neurotic suppressor medications
7. Individual with active otitis media or perforation of tympanic membrane
8. Individual with abnormal liver and kidney function (GFR lower than 60)
9. Individual who cannot sit or stand without assistant
10. Individual with urine pregnancy test positive or in pregnancy condition

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dizziness Handicap Inventory score (DHI-T) Pre-dose and at 1,28,56 and 84 day post-start DHI-T score

Secondary Outcome Measures

Name	Time	Method
Vestibular function Pre-dose and at 84 day post-dose Posturography,VOR gain Pre-dose and at 84 day post-dose vHIT,Blood flow perfusion Pre-dose and at 56 days post-dose Optical coherence tomography angiography