| CTRI Number |
CTRI/2024/12/078318 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
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Public Title of Study
|
Exploring Hearing Sensitivity in Anemia Patients: A Study on Noise Tolerance and Hearing Tests
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Scientific Title of Study
|
An Observational Study to evaluate the Karnendriya Shaithilya in Pandu Rogi Iron Deficiency Anemia through Noise Sensitivity Scales and Audiometry Test |
| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritu Verma |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 107
Department of Roga Nidana evum Vikriti Vigyana
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9306455569 |
| Fax |
|
| Email |
drrituverma1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nithin Krishnan |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 107
Department of Roga Nidana evum Vikriti Vigyana
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9620300103 |
| Fax |
|
| Email |
drnithinkrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Verma |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital |
| Address |
A 107
Department of Roga Nidana evum Vikriti Vigyana
Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9306455569 |
| Fax |
|
| Email |
drrituverma1@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ritu Verma |
| Address |
A 107
Department of Roga Nidana evum Vikriti Vigyana
Shri Dhanwantry Ayurvedic College and Hospital |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Verma |
Shri Dhanwantry Ayurvedic College and Hospital |
A 107
Department of Roga Nidana evum Vikrti Vigyana
Shri Dhanwantry Ayurvedic College and Hospital Sector 46 Chandigarh
Chandigarh
CHANDIGARH |
9306455569
drrituverma1@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee Shri Dhanwantry Ayurvedic College and Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
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Inclusion Criteria
|
| Age From |
15.00 Day(s) |
| Age To |
49.00 Day(s) |
| Gender |
Both |
| Details |
Patients with symptoms of Iron Deficiency Anemia
Low haemoglobin
Loss of lusture
Sensory dysfunction
Subjects with dearanged findings in Iron Profile
|
|
| ExclusionCriteria |
| Details |
Deafness and other pathological conditions of ear
Causes of Anemia other than iron deficiency
Hypertension
Psychiatric Conditions
Substance abuse
Diabetes
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
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.
Findings of the study may help to revalidate the concept mentioned in our Ayurvedic texts.
|
Baseline |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
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%
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