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临床试验/CTRI/2023/09/058006
CTRI/2023/09/058006已完成3 期

Clinical evaluation of siddha formulation Seenthil chooranam (internal) and Vetitver thailam (external) in the management of Neer Peenisam (sinusitis) among out-patients attending Ayothidoss Pandithar hospital, National Institute of Siddha

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月30日最近更新:

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
The outcome will be mainly assessed by reduction in clinical symptoms after the

研究概览

简要总结

INTRODUCTION:

This is a clinical trial that evaluates the effectiveness of siddha formulation Seenthil chooranam ( internal) and Vetiver thailam (external) in the management of Neer peenisam (Sinusitis) in patients through  Adelaide Disease Severity Score and clinical lab parameters–TC,DC, ESR, AEC and IgE pre and post treatment. Sinusitis is the inflammation of the sinuses, which are air filled cavities in the skull. The types of sinuses are maxillary, frontal, ethmoid and sphenoid. Among these maxillary and ethmoid sinuses quite often gets infected. The most frequently involved one is maxillary sinus. The overall prevalence of sinusitis was found to be 1.11%. The mean age of patients was 34 years and 70% of patients were suffering from chronic maxillary sinusitis. There is 20% of patients have positive family history of sinusitis.

PRIMARY OBJECTIVE:

To evaluate the clinical effectiveness of siddha formulations Seenthil chooranam (internal) and vetiver thailam (external) in the management of neer peenisam (sinusitis) by using Adelaide Disease Severity Score.

SECONDARY OBJECTIVE:

To observe changes in clinical lab parameters–TC,DC, ESR, AEC and IgE pre and post treatment.

MATERIALS AND METHODS:

A total of 30 diagnosed adult patients of  Neer peenisam  willing to participate in the study , by signing the consent form will be enrolled in the study . Having Headache / sneezing/nasal congestion/ rhinorrhea/ postnasaldrip/ facial pain/ anosmia, Pain and tenderness over paranasal sinuses, Patient who has Adelaide Disease Severity Score above 12 will be included in this study and who are known case of migrane,tumours in PNS X-ray, Pregnancy and lactating mother, Patients with uncontrolled Diabetes mellitus are excluded. Assesssment will be done through Adelaide Disease Severity Score and clinical lab parameters–TC,DC, ESR, AEC and IgE pre and post treatment.

RESULTS AND DISCUSSION: The results will be statistically analysed.

KEYWORDS:

Neer peenisam, Sinusitis, Seenthil chooranam , vetiver thailam

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
14.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Headache / sneezing/nasal congestion/ rhinorrhea/ postnasaldrip/ facial pain/ anosmia.
  • 2.Pain and tenderness over paranasal sinuses.
  • 3.Patient who has Adelaide Disease Severity Score above
  • 4.Patients who are willing to give informed consent.
  • 5.Adults who are already diagnosed with sinusitis are included.

排除标准

  • • K/C/O Migraine.
  • • Patients who have tumours in PNS X-ray • Pregnancy and lactating mother.
  • • Patients with uncontrolled Diabetes.
  • • Patients who are not willing to participate in the study will be excluded from the study.

结局指标

主要结局

The outcome will be mainly assessed by reduction in clinical symptoms after the

时间窗: 18 months

treatment by using Adelaide Disease severity score below 12

时间窗: 18 months

次要结局

  • To observe changes in clinical lab parameters–TC, DC, ESR, AEC & IgE pre and post treatment(18 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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