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临床试验/CTRI/2026/01/102594
CTRI/2026/01/102594尚未招募2/3 期

A Clinical study on Curative effect of Karnaprakshalan with Panchvalkaladi Kwath and Kshara Taila Karna Pichu in Karnasrava with special reference to Chronic Suppurative Oitis Media.

Government Ayurvedic College and Hospital KadamkuanPatna1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1

研究概览

简要总结

Introduction Chronic Suppurative Otitis Media (CSOM) is a common chronic ear disease characterized by persistent ear discharge through a perforated tympanic membrane, often leading to hearing impairment and reduced quality of life. In Ayurveda, a similar condition is described as Karnasrava, which is mentioned in classical texts such as Sushruta Samhita and Charaka Samhita.

PurposeThe present study is planned to evaluate the curative and symptomatic effects of Karnaprakshalana with Panchvalkaladi Kwath followed by Karna Pichu with Kshara Taila in patients suffering from Karnasrava with special reference to CSOM. Panchvalkaladi Kwath possesses cleansing, anti-inflammatory, and wound-healing properties, while Kshara Taila is traditionally indicated in chronic ear diseases due to its antimicrobial and healing actions.

This is an open-label, randomized, single-group clinical study in which 30 clinically diagnosed patients of Karnasrava (CSOM) aged between 10 and 70 years will be selected from the OPD and IPD of the Department of Shalakya Tantra, Government Ayurvedic College and Hospital, Patna. Karnaprakshalana will be performed using Panchvalkaladi Kwath, followed by Karna Pichu with Kshara Taila for a treatment duration of 30 days, with follow-up up to 2 months.

Main outcome measures Assessment will be done based on changes in ear discharge, size of tympanic membrane perforation, and hearing status, evaluated clinically, otoscopically, and audiometrically. The study aims to establish the therapeutic efficacy of these Ayurvedic procedures and to provide a safe, cost-effective alternative for the management of CSOM, thereby helping in early prevention of hearing loss.

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
10.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients full fill following condition will be Enrolled in the Trials 1)The patients having age between 10 to 70 years.
  • The patient having clinical sign and symtoms of karnasrava i.e CSOM irrespective of sex and socio-ecnomical status.

排除标准

  • Patients have following condition will not be Enrolled in the Trials 1)Age above 70 and less than 10 years.
  • Immunocompromised patients e.g. HIV,DM,TB etc.
  • Severe deformities of external and middle ear with severe SNHL.
  • Known cases of vertigo.
  • Patient with subtotal perforation or perforation with destruction of annulus tympani.
  • Patient with ear polyp ,marginal perforation and intra temporal and intra cranial complication.
  • Patient with atticoantral CSOM(unsafe/dangerous type).

研究者

发起方
Government Ayurvedic College and Hospital KadamkuanPatna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sunder Singh

Government Ayurvedic College and Hospital,Kadamkuan,Patna

研究点 (1)

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