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临床试验/CTRI/2024/09/073187
CTRI/2024/09/073187尚未招募2 期

Efficacy of Tuberculinum in comparison with Individualised Homoeopathic medicine in reducing episodes of recurrent respiratory tract infections in children: A comparative, single blind, clinical trial

DrSnehal Bhagavan Patil1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年9月11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
120
试验地点
1
主要终点
reduction in the number of episodes of

研究概览

简要总结

TITLE OF TOPIC – EFFICACY OF TUBERCULINUM IN COMPARISON WITH INDIVIDUALISED HOMOEOPATHIC MEDICINE IN REDUCING EPISODES OF RECURRENT RESPIRATORY TRACT INFECTIONS IN CHILDREN: A COMPARATIVE, SINGLE BLIND, CLINICAL TRIAL.

PURPOSE OF TRIAL

As there is increased prevalence of Recurrent respiratory tract infections, in conventional treatment there is only focus on symptomatic relief. There is no specific treatment for preventing recurrence of disease. Nevertheless, misuse and overuse of antibiotics results in unnecessary drug-related adverse events, contributes to antibiotic resistance and increased clinical failure, and incurs further medical costs.(3)

Role of individualized Homoeopathic medicines in treatment of recurrent respiratory tract infections is known and also literatures are available on efficacy of tuberculinum in treating the recurrency of RRIs (20) though not many researches are done.

INTRODUCTION

Recurrent respiratory infections (RRIs) are a common occurrence in young children. The most widely accepted definition is the occurrence of eight or more documented airway infections per year in pre-school-aged children (up to 3 years of age) or of 6 or more in children older than 3 years of age, in the absence of any underlying pathological condition.(1)

The National Family Health Survey 5, conducted in 2019–2020, reported a 2.4% prevalence of acute respiratory infections (ARIs) in the preceding 2 weeks in the urban areas and a 3.8% in the rural areas in Maharashtra state. In the Indian slum areas, ARIs constitutes more than two-thirds of all childhood illnesses. Globally, in 2010, nearly 265,000 in-hospital deaths of young children were attributed to ARIs, 99% of which were reported in developing countries. In the urban slum areas, ARIs constitutes over two-thirds of all childhood illnesses.(2)

Recurrent respiratory infections lead to significant morbidity and mortality among paediatric patients. RRIs in children can lead to the number of consequences such as frequent visits to paediatric clinics, school absenteeism, overuse of antibiotics and bacterial resistance, decreased quality of life, absenteeism of parents at work and economic burden on the family.(3)

Symptoms normally include at least one of the following: runny nose, nasal congestion, sore throat, cough, earache, and/or shortness of breath lasting at least two to three days or more.(3)

Another important consequence of paediatric RRIs is the rampant and irrational use of antibiotics. Most of the respiratory infections are viral in origin and frequent irrational use of broad-spectrum antibiotics can lead to antibacterial resistance. Despite the use of antibiotics and vaccines, the incidence of RRIs is still high in children due to the deficiency of the immune system.(1)

Homoeopathy treats patients through the holistic approach which considers treating patient as a whole and not just the disease. Homoeopathic medicines are prescribed on the basis of individualization.  Where each patient is given a different remedy depending on his or her constitution that is considering his mental and physical make up, past history and family history.  So on this basis we have the individualised homoeopathic medicines for RRIs. but we also have Tuberculinum as one of our main homeopathic medicine for children, especially those who suffer from recurrent infection, but not much proving of Tuberculinum is done yet in recurrent respiratory tract infections.

So Keeping burden of disease in mind and ability of Tuberculinum to treat tendency of recurrency, hence the study is designed to compare the efficacy of Tuberculinum with Individualised homoeopathic medicines in reducing episodes of RRIs.

AIM: to study the efficacy of tuberculinum in comparison with individualised homoeopathic medicine in reducing episodes of recurrent respiratory tract infections in children up to 2 years.

OBJECTIVES:

To assess the reduction in the frequency, duration and intensity of recurrent respiratory tract infections in children up to 2 years.

To study the effect of treatment on clinical presentation of recurrent respiratory tract infection in children up to 2 years.

To study the symptoms of tuberculinum.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children with recurrent respiratory tract infections more or equal 8 episodes per year if aged less than 3 years more or equal 6 episodes per year if aged more or equal 3 years.

排除标准

  • Lower Respiratory Tract Infections will be excluded K/C/O history of Tuberculosis Children with congenital anomaly affecting upper respiratory tract.
  • Children with Immunocomprised diseases and other co-morbidities.

结局指标

主要结局

reduction in the number of episodes of

时间窗: 1 year

respiratory tract infection.

时间窗: 1 year

次要结局

  • effect of tuberculinum in reducing recurrence of respiratory tract infections(1 year)

研究者

发起方
DrSnehal Bhagavan Patil
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Snehal Bhagavan Patil

YMT Homoeopathic medical college and PG Institute

研究点 (1)

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