Effect of amalaki patra and bandhujiva patra along with ghee in phonotrauma-induced hoarseness - An open-label RCT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Acoustic analysis software – PRAAT to measure shimmer, jitter, and HNR ratio
研究概览
简要总结
This is an open label double arm randomized controlled trial to study the effect of amalaki patra and bandhujiva patra churna along with ghee in phonotrauma-induced hoarseness in people of age 18 to 60 years old. The test group will be given 12 grams of amalaki patra and bandhujiva patra churna with ghee for 5 days. The control group will follow relative voice rest and vocal hygiene for 5 days.
Null Hypothesis: The administration of amalaki patra and bandhujiva patra churna with ghee for 5 days, is not as effective as relative voice rest and vocal hygiene in changing the scores of acoustic parameters -jitter, shimmer and HNR as measured by PRAAT, GRBAS scale and VHI in individuals with phonotrauma-induced hoarseness of voice
Alternative Hypothesis: The administration of amalaki patra and bandhujiva patra churna with ghee for 5 days, is more effective than relative voice rest and vocal hygiene in changing the scores of acoustic parameters -jitter, shimmer and HNR as measured by PRAAT, GRBAS scale and VHI in individuals with phonotrauma-induced hoarseness of voice.
Primary objective: To acoustically analyse the jitter, shimmer, and HNR ratio of voice using PRAAT pre and post-test
Secondary objective:
· To assess the GRBAS scale pre & post test
· To assess the VHI scale pre & post 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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Hoarseness of voice induced due to shouting, screaming, singing and prolonged speaking, 2)With or without acute non-infective laryngitis 3)Those who are willing to participate in the study and signed the informed consent form.
排除标准
- •Organic lesions in vocal cord and oropharynx except vocal nodules, 2)Afflicted with common cold, 3)Productive cough, 4)Tonsillitis, 5)Goitre.
- •Inflammed cervical lymph nodes 7)Congenital voice disorders 8)Chronic smokers 9)Upper respiratory allergies to pollen & dust.
结局指标
主要结局
Acoustic analysis software – PRAAT to measure shimmer, jitter, and HNR ratio
时间窗: Day 0 and day 6
次要结局
- GRBAS Scale for perceptual assessment of voice quality - rated by a qualified Speech Language Pathologist
- Voice handicap index (VHI) (English & Malayalam)(Day 0 and day 6)
研究者
Dr Mokana Ranee S
Amrita School of Ayurveda