The effect of individualized homoeopathic medicine in centesimal potency in treatment of Benign Paroxysmal Positional Vertigo: An open label, single arm, prospective study in adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Primary outcome: 5 item BPPV sub-scale of DHI- A summation of the following five items from the DHI: 1) looking up, 2) getting out of bed, 3) quick head movements, 4) rolling over in bed, and 5) bending. Scores are in the range of 0-4 for each item (Always to No); thus total score ranges from 0 to 20; higher score indicates worse symptoms.
研究概览
简要总结
Benign paroxysmal positional vertigo is clinically characterized by recurrent spells of vertigo, lasting a few minutes, associated with changes in head position often provoked by rolling over in bed. The typical symptoms of BPPV occur in clusters that persist for several days. There is a brief (10–15 sec) latency period following a head movement before symptoms develops, and the acute vertigo subsides within 10–60 seconds, though the patient may remain imbalanced for several hours. It occurs due to free-floating debris/otoliths in the semicircular canal (canalolithiasis) or debris/otoliths attached to the cupula (cupulolithiasis). These debris/otoliths are considered to originally accumulate after detachment from the neuroepithelium of the utricular macula secondary to a type of degeneration. The pathology is based on displacement of the cupula due to either free-floating debris/otoliths in the semicircular canal or attachment of debris/otoliths to the cupula. Following obtaining screening & consent using specified selection (inclusion and exclusion) criteria, 34 eligible Participants will be included in the trial and Individualized homoeopathic medicine will be prescribed on the basis of totality of symptoms. Patients will be followed up every four weeks interval for three months. Following that, baseline outcome data 5 item BPPV sub scale of DHI , DHI (25 items) to be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients experiencing spinning sensations for short duration (Paroxysmal): Lasts only seconds to minutes (usually less than 60 seconds) which is triggered by change of positions of head like tilting the head, rolling over in bed, looking up or under, sudden head motion.associated with nystagmus (ICD-11 diagnostic code AB31.2); confirmed by positive Dix-Hallpike manoeuvre or positive horizontal roll test.
- •Age between 18-65 years.
- •Patients of all sexes including transgenders.
- •Literate patients; ability to read English, Bengali or Hindi and illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
- •Willing to take part in the study and give written informed consent voluntarily.
排除标准
- •Vertigo due to causes other than BPPV.
- •Patients having central vertigo which is excluded by HINTS examination.
- •(i.e Head impulse, Nystagmus, Test of Skew)
- •Patients suffering from hypertension, hypotension, anaemic, uncontrolled diabetes mellitus, cardiovascular diseases, cervical spondylosis.
- •Patient having psychological or mental instability.
- •Use of labyrinthine suppressants in past 2 weeks.
- •Patients taking any drugs that causes dizziness, light headedness.
- •Unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill or critically ill patients, mentally disabled people.
- •Pregnant and postpartum women, nursing mothers.
- •Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other forms of substance abuse and/or dependence.
- •Already been in homoeopathic treatment for any chronic illness for the last 6 months.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Primary outcome: 5 item BPPV sub-scale of DHI- A summation of the following five items from the DHI: 1) looking up, 2) getting out of bed, 3) quick head movements, 4) rolling over in bed, and 5) bending. Scores are in the range of 0-4 for each item (Always to No); thus total score ranges from 0 to 20; higher score indicates worse symptoms.
时间窗: At baseline, every 4 weeks, up to 3 months
次要结局
- To detect the differences in sign and symptoms during the treatment of BPPV by(using DHI Scales (25 items) after 3 months of intervention.)
研究者
Anik Dey
The Calcutta Homoeopathic Medical College and Hospital