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临床试验/CTRI/2020/12/029618
CTRI/2020/12/029618已完成2/3 期

Randomized Controlled Trial To Evaluate Efficacy Of Nidigdhikadi Kwatha In Management Of Peenasa (Chronic Simple Rhinitis)

Sane Guruji Arogya Kendra1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年1月3日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
74
试验地点
1
主要终点
Primary outcome will be evaluation of efficacy of Nidigdhikadi Kwatha in Peenasa Vyadhi w.r.t Chronic Simple Rhinitis

研究概览

简要总结

This study is open labelled randomized controlled clinical trial toevaluate the effect of Nidigdhikadi Kwatha daily orally once in a day for 21daysin comparison with Tab Levocetrizine 5mg in combination with Phenylephrine 10mgat night in patients affected with Peenasa Vyadhi w.r.t Chronic Simple Rhinitis.The Primary outcome will be effect of Nidigdhikadi Kwatha and the secondaryoutcome will be comparison between trial drug and control drug in management ofPeenasa Vyadhi w.r.t Chronic Simple Rhinitis

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients fulfilling the diagnostic criteria of Peenasa(Chronic Simple Rhinitis).
  • Patients suffering from three or more the following symptoms for more than one months were selected for study.( Nasal obstruction, Nasal discharge, Headache , Swollen turbinate’s, Post-Nasal discharge ) 3) A patients having age group 18 to 60 years.
  • Patient willing to participate in the study.
  • Patients were recruited irrespective of sex, religion, occupation.

排除标准

  • Pregnant women and Children.
  • Patients with history of congenital disorder of Nose.
  • Patients suffering from gross deviation of nasal septum and associated with other nasal pathology like nasal polyp etc.
  • Patients with uncontrolled systemic diseases like Diabetes Mellitus and Hypertension.
  • Chronic simple Rhinitis associated with Hyperthyroidism, Exanthemas, Adenoidal Hyperplasia, Choanal Atresia and Nasal Tumors.
  • Patient having Angle-Closure Glaucoma and Pyloric Stenosis.

结局指标

主要结局

Primary outcome will be evaluation of efficacy of Nidigdhikadi Kwatha in Peenasa Vyadhi w.r.t Chronic Simple Rhinitis

时间窗: The drug will be given for 21 days.The efficacy will be assessed on the basis of VAS SCALE for symptoms before and after treatment. The patients will be assessed before and after treatment. Total duration of the study will 18 months.

次要结局

  • A comparison between efficacy(of Nidigdhikadi Kwatha and Tab Levocetrizine 5mg)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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