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临床试验/CTRI/2024/09/074471
CTRI/2024/09/074471尚未招募2 期

Clinical Evaluation Of Kshaumadi Karnadhoopana And Rasnaadi Guggulu in Karnasrava (Chronic Suppurative Otitis Media)

Uttarakhand Ayurved University Dehradun1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Relief in sign and symptoms-

研究概览

简要总结

Among 28 ear diseases mentioned by Acharya Sushruta Karnasrava is one of them. Available treatment protocols for CSOM in modern system of medicine relies upon  antibiotics and pain killers.

CSOM is a frustrating entity for both patients and otolaryngologists as it requires long term treatment and medications used for its treatment has limitations like acidity, loss of hearing and unusual taste in mouth.

So the present study will be planned to study the effect of Ayurvedic formulation on Karnasrava.

Case will be selected from OPD/IPD of Rishikul Campus Hospital, U.A.U. Haridwar (UK) INDIA.

A written informed consent will be obtained after counselling of patients participating in the study.

Patients will be treated with Dhoopana therapy, local application and oral drug.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • 1.Patients willing to register 2.Patients within the age group of 16-60 years 3.Patients having specific signs and symptoms of CSOM and karnasrava 4.Tubotympanic (SAFE) type of CSOM 5.Active cases of Tubotympanic CSOM with chronicity less than 2yrs.

排除标准

  • 1 Patients not willing to participate in the study.
  • 2 Pregnant women and lactating mothers.
  • 3 Patients with the complications of CSOM.
  • 4 Systemic diseases like DM, Meningitis, Tuberculosis, etc.
  • 5 Atticoantral (Unsafe) type of CSOM.
  • 6 Non- vaccinated Covid-19 patients.

结局指标

主要结局

Relief in sign and symptoms-

时间窗: Followup at an interval of 15 days and 30 days.

a)Earache

时间窗: Followup at an interval of 15 days and 30 days.

b)Discharge

时间窗: Followup at an interval of 15 days and 30 days.

c)Consistency of discharge

时间窗: Followup at an interval of 15 days and 30 days.

d) TM perforation size

时间窗: Followup at an interval of 15 days and 30 days.

e) External examination by torch and otoscopic examination to rule out TM perforation size

时间窗: Followup at an interval of 15 days and 30 days.

f)Hearing assessment done by PTA,Rinne and Weber test

时间窗: Followup at an interval of 15 days and 30 days.

次要结局

  • Relief in sign & symptoms-(a)Earache)

研究者

发起方
Uttarakhand Ayurved University Dehradun
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Arun Kumar

Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun)

研究点 (1)

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