Efficacy of Individualized Homoeopathy in Management of Chronic Suppurative Otitis Media: A Single-blind, Randomized, Plcebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- • To evaluate the VAS for ear discharge, pain, and deafness
研究概览
简要总结
Title : Efficacy of Individualized Homoeopathy in management of Chronic suppurative otitis media: A single blind, Randomized, Placebo controlled trial
Study Duration: 2year 6months
Study Site: DDPRCRI(H.), Noida
Objectives:
-
Primary: To evaluate the efficacy of Individualized homoeopathic medicine in the management of chronic suppurative otitis media using VAS for ear discharge, pain and deafness
-
Secondary: To evaluate efficacy of individualized homoeopathy in CSOM by comparing Clinical and Otoscopy examination.
To assess hearing level using audiometry(Pure tone) test.
To evaluate quality of life using COMOT-15 Questionnaires.
To assess recurrence of CSOM during treatment
Sample size: 140
Inclusion criteria: Diagnosed case of tubotympanic type of CSOM of duration >2 weeks
Age- 1-45 yr
Both sexes
Subject who have given written informed consent
Exclusion criteria:
CSOP of atticoantral type(unsafe)
Subject with H/O noise exposure
Subject with H/O ear surgery
Subject with uncontrolled chronic illness.
Subject not willing to part of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of tubotympanic type chronic suppurative otitis media of more than 2weeks Age group from 1 to 45 years Both sexes Subjects who have given the written informed consent.
排除标准
- •chronic suppurative otitis media of atticoantral type Patient with history of noise exposure Patient with history of ear surgery Patient not willing to be part of the study Patients with uncontrolled chronic illness.
结局指标
主要结局
• To evaluate the VAS for ear discharge, pain, and deafness
时间窗: • To assess and compare the symptomatic improvement in ear discharge, pain and deafness using VAS, will be assessed at baseline and every month. | • Otoscopy and audiometry will be done at baseline, 3rd, 6th, 9th and 12th month. | •COMOT-15 Questionnaires will be assess at baseline and every month.
To evaluate changes by clinical and otoscopy examination.
时间窗: • To assess and compare the symptomatic improvement in ear discharge, pain and deafness using VAS, will be assessed at baseline and every month. | • Otoscopy and audiometry will be done at baseline, 3rd, 6th, 9th and 12th month. | •COMOT-15 Questionnaires will be assess at baseline and every month.
To assess the hearing level using audiometry test
时间窗: • To assess and compare the symptomatic improvement in ear discharge, pain and deafness using VAS, will be assessed at baseline and every month. | • Otoscopy and audiometry will be done at baseline, 3rd, 6th, 9th and 12th month. | •COMOT-15 Questionnaires will be assess at baseline and every month.
To evaluate the quality of life using chronic otitis media outcome
时间窗: • To assess and compare the symptomatic improvement in ear discharge, pain and deafness using VAS, will be assessed at baseline and every month. | • Otoscopy and audiometry will be done at baseline, 3rd, 6th, 9th and 12th month. | •COMOT-15 Questionnaires will be assess at baseline and every month.
test-15(COMOT -15) questionnaire
时间窗: • To assess and compare the symptomatic improvement in ear discharge, pain and deafness using VAS, will be assessed at baseline and every month. | • Otoscopy and audiometry will be done at baseline, 3rd, 6th, 9th and 12th month. | •COMOT-15 Questionnaires will be assess at baseline and every month.
To assess the recurrence of CSOM during treatment
时间窗: • To assess and compare the symptomatic improvement in ear discharge, pain and deafness using VAS, will be assessed at baseline and every month. | • Otoscopy and audiometry will be done at baseline, 3rd, 6th, 9th and 12th month. | •COMOT-15 Questionnaires will be assess at baseline and every month.
次要结局
- 1.To compare and assess the clinical improvement using otoscopy and physical examination from(baseline, 3rd, 6th, 9th and 12th month)
研究者
Dr Punam Kumari
Dr D P Rastogi Central Research Institute of Homoeopathy