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临床试验/CTRI/2024/10/075936
CTRI/2024/10/075936尚未招募不适用

An observational study on Chronic Sinusitis (Waram-tajaweef al-anf muzmin) and theurapetic evaluation of aromatherapy (shamoom) in its management

Islamic University of Science and technology1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
X- Ray Para nasal Sinuses

研究概览

简要总结

WaramTajäwéf al-AnfMuzmin (Chronic Sinusitis) is the chronic inflammation of para nasal sinuses which affects all people worldwide.Symptoms and signs of NazlaBäridMuzmin have been described in details in of Unani literature which closely resemble the symptoms of chronic sinusitis, although IltihäbTajäwéf al-Anf or WaramTajäwéf al-Anf (Sinusitis) has not been mentioned as a disease in literature of Unani Medicine.(1,2,3,4) Therefore, NazlaBäridMuzmin has been considered as WaramTajäwéf al-AnfMuzmin (Chronic Sinusitis). WaramTajäwéf al-AnfMuzminis called chronic sinusitis in modern medicine, which is a chronic inflammatory condition of upper respiratory tract involving the paranasal sinuses. It is usually followed by coryza and cold or sometimes is caused by dental infection, deeply seated in upper jaw. Most of the times, the maxillary sinuses are involved. However, it may also affect other sinuses on one or both sides.(5,6,7)Chronic sinusitis is characterized by symptoms of sinusinflammation lasting more than 12 weeks. This illness is mostcommonly associated with either bacteria or fungi, and clinicalcure in most cases is very difficult.28 In this stage, the damageto the mucus membrane occurs which leads to the impairmentof the ciliary activity and thickening of mucus membrane. Thiscondition may progress until the sinus is filled with polypi andpus, which is discharged at frequent intervals into the nose.Symptoms are varied and complaint may be of frequent colds,or an unpleasant taste or a bad smell in the nose. The discharge is frequently foul. As the condition settles into the chronic stage, pain and tenderness disappear The treatment of choice for chronic sinusitis in conventional medicine is nasal or oral corticosteroids, antibiotics, nasal sprays, decongestants. The drugs are associated with various side effects like nose bleeds, stinging sensation in the throat and nose, in rare cases nasal perforation can also occur due to use of nasal corticosteroids. Therefore a polyherbal formulation comprising of Pudina (Menthaspicata L.), Ajwain(PtychotisAjowan), Ustukhudus (Prunella Vulgaris), Marzanjosh (OriganumMajorana) and Guletesu (Butea Frondosa) will be given as inhalation or Shamoom to the patients and efficacy will be tested.

Study design: Open observational study.

 Sample size: 20 patients.

Intervention.

**Test drugs:**Pudina, Ajwain, Ustukhuddus, Marzanjosh, GuleTesu.

 Method of Prepration:

 Dosage: 5 gm of each drug taken in 200ml of water and boiled and shamoom or inhalation taken daily at bed time for ten minutes.

 Route of Administration: Inhalation

 Duration   of Protocol: 45 days with follow up as ( 15th, 30th,45th)

Duration of Study: 2 years

 Procedure of study:

Enrolled cases of Sinusitis will be taken, after obtaining a written informed consent. The patients will be treated with test drugs and pre and post treatment subjective and objective findings (effects) will be compared and its significance will be evaluated through a suitable statistical test.

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
15.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinically diagnosed patients of Sinusitis with headache, nasal obstruction, running nose, malaise, hyposmia 2.Irrespective of all genders.
  • 3.Patient’s between15-60 years of age.

排除标准

  • 1.Patients below 15 and above 60 years of age.
  • 2.Pregnant and Lactating mothers.
  • 3.Patients who fail to give consent.
  • 4.Patients with history of Cardiovascular, Endocrine, Renal and Liver diseases 5.Patients with COPD, Asthma and any severe lung disease 6.Pregnancy, Lactation, Patients on Oral Contraceptives.

结局指标

主要结局

X- Ray Para nasal Sinuses

时间窗: 2 years

次要结局

  • SNOT 22(2 years)

研究者

发起方
Islamic University of Science and technology
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Tabasum Fatima

Islamic University of Science and Technology

研究点 (1)

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