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临床试验/CTRI/2024/12/078318
CTRI/2024/12/078318尚未招募不适用

An Observational Study to evaluate the Karnendriya Shaithilya in Pandu Rogi Iron Deficiency Anemia through Noise Sensitivity Scales and Audiometry Test

Dr Ritu Verma1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年1月1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
200
试验地点
1
主要终点
Decreased tolerance of sound, tinnitus, hearing loss may be observed with decreasing levels of Hb and Iron Profile values as per Karnendriya Shaithilya as a lakshana of Pandu.

研究概览

简要总结

An Observational Study to evaluate the  Karnendriya Shaithilya in Pandu Rogi (Iron Deficiency Anemia) through Noise Sensitivity Scales and Audiometry Test.  

Introduction        Pandu  is a disease manifested due to the vitiation of Pitta Dosha. Acharya Charaka considers it a Rasapradoshaja Vikara and acharya Sushruta identifies Pandu as a Raktavahasroto Viddha Lakshana. According to Acharya Charaka are Shithilaendriya is one of the pathological condition of Pandu. The symptoms of Pandu Roga bear resemblance to anemia in modern  medical understanding. Anemia encompasses various types, with Iron Deficiency Anemia being the most prevalent nutritional deficiency ailment  globally. IDA may affect visual and auditory functioning.  Need of the Study          Given that Pandu Roga is classified as a Rasapradoshaja Vikara and is associated with symptoms like Indriyashaithilya (sensory dysfunction), particularly Shabdasahishnuta (sound sensitivity). So the aim of the study is to correlate the findings of Audiometry & Noise sensitivity Scales with Iron Profile & Haemoglobin level observed in Pandu patients with karnendriya shaithilya.          Aim & Objectives   This study aims to investigate Karnendriya Shaithilya in Pandu (Iron Deficiency Anemia) patients by correlating the findings of Audiometry & Noise sensitivity Scales with Iron Profile & Haemoglobin level.        Objectives       To assess Shabdasahishnuta in Pandu Rogi via Noise sensitivity Scales  To assess Karnashveda in Pandu Rogi via Audiometric Evaluation.

Materials and Methods       200 participants for the study will be recruited from the OPD and IPD of Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh, along with its affiliated institutes. Blood samples will be collected from all participants to assess their hemoglobin (Hb) and iron profiles. Individuals exhibiting samanya lakshanas of pandu and abnormal Hb and iron profiles along with samanya lakshana of pandu will be included for the study. Karnendriya Shaithilya (dysfunction in auditory senses) will be evaluated in both groups using audiometry and Noise Sensitivity Scales. Subsequently, the results will be analyzed to determine any potential correlation between the findings of audiometry and Noise Sensitivity Scales with the Hb and iron profile levels of the participants. Stastistical  Analysis

The minimum required sample size was calculated to be 179.This sample size was estimated using COCHRAN(1963) formula for prevalence of 13% with 95%4 confidence level with critical value Z α /2 at 1.96 & acceptable margin error is 5%

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Day(s) 至 49.00 Day(s)(—)
性别
All

入选标准

  • Patients with symptoms of Iron Deficiency Anemia Low haemoglobin Loss of lusture Sensory dysfunction Subjects with dearanged findings in Iron Profile.

排除标准

  • Deafness and other pathological conditions of ear Causes of Anemia other than iron deficiency Hypertension Psychiatric Conditions Substance abuse Diabetes.

结局指标

主要结局

Decreased tolerance of sound, tinnitus, hearing loss may be observed with decreasing levels of Hb and Iron Profile values as per Karnendriya Shaithilya as a lakshana of Pandu.

时间窗: Baseline

Findings of the study may help to revalidate the concept mentioned in our Ayurvedic texts.

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Dr Ritu Verma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ritu Verma

Shri Dhanwantry Ayurvedic College and Hospital

研究点 (1)

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