跳至主要内容
临床试验/CTRI/2023/12/060810
CTRI/2023/12/060810尚未招募不适用

Comparative assessment on the efficacy of Epleys Maneuver and its combination with Kalyanaka grita Nasya,Drakshadi kashaya,Eladi vati in the management of Benign Paroxysmal Positional Vertigo(BPPV).

Dr Praveena Nair1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1. Vertigo symptom scale (VSS sf ) – least total score.

研究概览

简要总结

BPPV is characterized by vertigo lasting for seconds associated with balancing problem, nystagmus, nausea and vomiting. It is the most common cause of vertigo worldwide with a prevalence of  10.7 - 140/100,000.Though it is a benign condition, 60 % of patients with BPPV require leave from work, 86 % experience interruption to activities of daily living, 38 % of patients fall down as a direct consequence, with incidence of both BPPV and falls increasing with increasing age.

Treatment recommendation include Canalith repositioning procedure(CRP), vestibular suppression medications and rehabilitative exercises. Despite the success of CRP showing odds ratio of 4.2 in resolution of symptoms 20% of BPPV doesnot benefit from it and shows mild negative outcomes. Vestibular medications are also not advised for long as it produces drowsiness, Cognitive deficits , Interference with driving vehicles or operating machineries. Datas are also not available showing widely accepted interval regarding CRP.

Reviewing the classics the symptoms of BPPV can be correlated to bhrama where a person feels that everything around him is spinning like a wheel “chakravat bhramana” caused due to the vitiation of pitta and vata with involvement of raja. Line of treatment can be according to doshapratyaneekata and its site of manifestation. In the present study kalyanaka grita nasya is chosen. Drakshadi kashaya and eladi vati  selected for internal administration is vatapittahara tridoshahara respectively and both are advised to be effective in bhrama.

Hence the present study is to assess whether Kalyanaka grita nasya, Drakshadi kashaya, Eladi vati with Epley’s Maneuver is more effective than Epley’s Maneuver alone in the management of BPPV. The clinical study will be carried out in 30 patients with BPPV who fulfil inclusion criteria belonging to either sex from OPD and IPD of Amrita School of Ayurveda. VSS- sf, DHI questionnaire and Dix Hallpike test will be assessed. Patient will be allocated into Group A and B. Consent will be taken in their own language before treatment, subjective parameters will be assessed and recorded in CRF. Group A will be given 4ml Kalyanaka grita marsha nasya, Drakshadi kashaya and eladi vati along with Epleys manuever and group B with  Epley’s maneuver alone for 30 days. After treatment subjective parameters will be assessed, also in the 4 followup on 45th,60th,75th ,90th day to assess the sustained effect of treatment. The data obtained will be tabulated and statistically analysed using Wilcoxon signed rank test.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of age 35-
  • 2.Patients presenting vertigo with or without nystagmus following the DHP.
  • 3.Patients fit for nasya karma.
  • 4.Patient willing to take internal medication.
  • 5.Patient with Vertigo symptom scale-short form(VSS-SF) score upto 45 6.Patient with Dizziness handicap inventory(DHI) score upto 80.

排除标准

  • 1.Patients who doesn’t fit the diagnostic criteria.
  • 2.Patients who are contra-indicated for Canalith repositioning maneuver 3.Pregnant and breast feeding patients.
  • DIAGNOSTIC CRITERIA : 1.Recurrent attacks of positional vertigo or positional dizziness provoked by lying down or turning over in supine position.
  • 2.Duration of attacks less than 1 min.
  • 3.Positional nystagmus elicited after a latency of only few seconds by Dix Hallpike manuever.
  • 4.Not attributable to another disorder.

结局指标

主要结局

1. Vertigo symptom scale (VSS sf ) – least total score.

时间窗: after 1 month

2. Dizziness Handicap Inventory( DHI)- least total score.

时间窗: after 1 month

3. Dix Hallpike test (DHP test)- negative test.

时间窗: after 1 month

次要结局

  • 1. Vertigo symptom scale (VSS sf ) – least total score.(2. Dizziness Handicap Inventory( DHI)- least total score.)

研究者

发起方
Dr Praveena Nair
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Praveena Nair

Department of Shalakyatantra,Amrita school of Ayurveda

研究点 (1)

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