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临床试验/CTRI/2024/03/064366
CTRI/2024/03/064366招募中2 期

Role of individualized homoeopathic medicines in the treatment of nasal inferior turbinate hypertrophy in adolescents and adults: An open-label, single-arm, quasi-experimental study

D.N.De Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
NOSE score

研究概览

简要总结

Nasal turbinate hypertrophy is Hypertrophy (enlargement) of nasal turbinates. Inferior turbinate hypertrophy, a condition where the tissue on the lateral (outside) walls of the nose are too large, causing nasal obstruction. While the worldwide prevalence of inferior turbinate hypertrophy is unknown, a large study by Clark et al, of over 1900 patients with sinonasal complaints revealed that 72% suffered from hypertrophied turbinates. However, this narrowing of the nasal cavity affects the physiological functions of the nasal mucosa, causing problems such as mouth breathing, dry oropharynx, nasal talking, sleep disorders, snoring, nasal congestion, stuffy nose when lying down, and secretions Nasal congestion may affect general health also causes irritability, fatigue, decreased quality of life. The treatment of inferior turbinate hypertrophy has been actively debated for over a century. The main goal of treatment is to minimize the symptoms and extent of hypertrophy of ITH. Although not life-threatening, chronic nasal obstruction significantly impairs patient’s quality of life affecting their daily social and working activities. Though the use of homoeopathic medicines is extensive globally to treat the condition, Research on nasal ITH in homoeopathic treatment limited. There is a notable research gap in understanding the effect and mechanism of homoeopathic intervention for nasal ITH. This provides the basis for to conduct an open-label, single-arm trial on 50 participants suffering from nasal ITH  in adolescents and adults using individualized homoeopathic medicines (IHMs) in outpatient departments(OPD) especially ENT and PG2 of D.N.De Homoeopathic Medical College and Hospital , Govt. of WB; 12, Gobindo Khatick Road, Tangra, Kolkata, WB 700046. Primary outcome will be measured by  using Nasal Obstruction Symptom Evaluation (NOSE) score; Sino Nasal Outcome Test-22(SNOT-22),  Measure Yourself Medical Outcome Profile version2 (MYMOP-2) questionnaire will be the secondary outcome. All the outcomes will be measured every month up to 3 months. Pre-post changes will be measured using appropriate statistical tests. Results will be published in scientific journals.

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
12.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients suffering from nasal ITH (ICD11-Code CA0E).
  • Patients aged between 12 and 65 years.

排除标准

  • 1.Not providing written informed assent and/or consent voluntarily.
  • Patients having nasal obstruction unrelated to inferior turbinate hypertrophy, such as symptomatic DNS, nasal polyps or tumors of nose.
  • Diagnosed cases of unstable mental or psychiatric illness or other systemic illness or life-threatening illness affecting quality of life or any organ failure.
  • Vulnerable population: Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, and mentally incompetent people.
  • Tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence (TAPS tool).
  • Self-reported immune-compromised state.
  • Already undergoing homoeopathic treatment for chronic disease.
  • Simultaneous participation in any other clinical trials.

结局指标

主要结局

NOSE score

时间窗: Baseline, every month, up to 3 months

次要结局

  • Sino Nasal Outcome Test-22 (SNOT-22)(Baseline, every month, up to 3 months)
  • Measure Yourself Medical Outcome Profile version2 (MYMOP-2) questionnaire(Baseline, every month, up to 3 months)

研究者

发起方
D.N.De Homoeopathic Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ruma Khatun

D. N. De Homoeopathic College and Hospital

研究点 (1)

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