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临床试验/CTRI/2019/04/018509
CTRI/2019/04/018509已完成2 期

Clinical evaluation of Shadbindu Taila Nasya and Chitraka Haritaki in the management of Pinasa (Chronic Rhinosinusitis)

CCRAS0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Patients of either sex with age between 18 and 60 years.
  • 2.Known case of Chronic Rhinosinusitis as per American Academy of Otolaryngology- Head and Neck Surgery Foundation (AAO-HNS) criteria (Annexure I)
  • A.Twelve weeks or longer of two or more of the following signs and symptoms:
  • ï?¶mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),
  • ï?¶facial pain-pressure-fullness, or
  • ï?¶ Decreased sense of smell.
  • B.Inflammation is documented by one or more of the following findings:
  • ï?¶purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region,
  • ï?¶polyps in nasal cavity or the middle meatus, and/or
  • ï?¶Radiographic imaging showing inflammation of the paranasal sinuses.
  • 3. Willing to give written informed consent for the participation.

排除标准

  • 1.Patients below 18 and above 60 years of age.
  • 2.History of chronic nasal or upper respiratory tract symptoms or disorders other than Sinusitis.
  • 3.Patients suffering with tonsillitis/adenoids.
  • 4.Patients who are on treatment with H1 antihistamine medication, Non-steroidal analgesics. Corticosteroids Nasal drops, Leukotriene antagonists, Nasal vasoconstrictors, or any other drugs that may have an influence on the outcome of the study.
  • 5.Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250 mg/dl).
  • 6.Patients with poorly controlled Hypertension ( >=160 / 100 mmHg).
  • 7.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders etc).
  • 8.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
  • 9.Symptomatic patients with clinical evidence of Heart failure.
  • 10.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL).
  • 11.Alcoholics and/or drug abusers.
  • 12.Pregnant women and Lactating mothers.
  • 13.Patients who have completed participation in any other clinical trial during the past six months.
  • 14.Any other condition which the investigator thinks may jeopardize the study.

研究者

发起方
CCRAS

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