跳至主要内容
临床试验/CTRI/2025/12/098945
CTRI/2025/12/098945尚未招募2 期

To Find Out The Effectiveness Of Constitutional Homoeopathic Remedy In The Treatment Of Acute Suppurative Otitis Media At Pediatric Age 5-13 years A Randomized Controlled Trial

Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月22日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1

研究概览

简要总结

Aim- To find out the effectiveness of Homoeopathic Medicine in case of Acute Suppurative Otitis Media

Objectives- To analyze the different trigger factor relevant to Acute Suppurative Otitis Media

To explore a group of most effective Homoeopathic medicine in the treatment of Acute Suppurative Otitis Media

INTRODUCTION-

Acute Suppurative otitis media is common cause of  morbidity in children .It defined as inflammation of mucoperiosteal lining of the middle ear  .If the duration of illness is more than two weeks it is termed as an Chronic Suppurative otitis media .Children are more prone for acute Suppurative otitis media because the Eustachian tube more communicating throat with ears are straight and short. Acute Suppurative otitis media may be one of the complication of other respiratory infections. It is nearby always a sequel to an upper respiratory tract infection which is seen commonly during childhood. ASOM in children is commonly caused by Streptococcus pneumoniae Haemophilis influenza  and Moraxella catarrhalis .Very rarely it may be caused by due to Staphylococcus and gram negative organism. In later is more common in immunocompromised hosts.

STUDY PROCEDURE-

The present study will be conducted with a target sample size of 100 participants. Each patient will undergo detailed case taking  including a comprehensive history and general physical examination  to confirm the diagnosis of Acute Suppurative Otitis Media  as per ICD-11 criteria. Only those patients meeting the eligibility requirements will be included in the study. Following inclusion all 100 participants will be randomized into two equal groups of 50 each using the dice method where odd numbers will be assigned to the treatment group and even numbers to the control group. The severity of ASOM will be assessed using the AOM-SOS (Acute Otitis Media–Severity of Symptoms) Scale before the initiation of treatment. Participants in the treatment group will receive individualized homeopathic medicines  while the control group will receive a placebo. Each patient will have a minimum of four follow-ups at intervals of seven days over a period of one month  with adjustments based on clinical condition. The AOM-SOS score will be recorded at each follow-up to monitor clinical improvement and evaluate treatment efficacy in both groups. After completion of the follow-up period  appropriate statistical tools will be applied to analyze the collected data. The results will be interpreted by comparing the changes in AOM-SOS scores between the individualized homeopathic treatment group and the placebo group followed by a detailed discussion and conclusion based on the findings.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
5.00 Year(s) 至 13.00 Year(s)(—)
性别
All

入选标准

  • Children in both sexes Age 5-13 years Patients parents willing to participate and provide informed consent.

排除标准

  • Inability to follow study protocol Patient with advance pathological condition along with Acute Suppurative Otitis Media will be excluded Chronic Suppurative Otitis Media -history of ear discharge lasting ,ore then 6 weeks Complication of ASOM including Matoiditid Facial nerve palsy Intracranial infection History of ear surgery or any congenital ear malformations.

研究者

发起方
Sri Ganganagar Homoeopathic Medical College, Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Koijam Allena Devi

Room no 102 Pediatric Department Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan

研究点 (1)

Loading locations...

相似试验