| CTRI Number |
CTRI/2025/03/082146 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation Between Pediatric Symptoms in Vedanadhyaya and Modern Medicine: A Cross-Sectional Study |
|
Scientific Title of Study
|
Correlation of pediatric disorders specific symptoms in Vedanadhyaya with Modern medicine– A Cross-Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSunny Prakash Khule |
| Designation |
Post Graduation student Dept Of Kaumarbhritya |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research centre wardha |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA 442001 India
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA
442001
India
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA 442001 India
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
07028490286 |
| Fax |
|
| Email |
sunnyprakashkhule@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRenu Rathi |
| Designation |
Professor And Head of Department |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research centre wardha |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA 442001 India
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9011058302 |
| Fax |
|
| Email |
renu.rathi@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrRenu Rathi |
| Designation |
Professor And Head of Department |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research centre wardha |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA 442001 India
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9011058302 |
| Fax |
|
| Email |
renu.rathi@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod(H) Wardha Maharashtra Pin - 442001 INDIA |
|
|
Primary Sponsor
|
| Name |
MAHATMA GANDHI AYURVED COLLEGE AND RESEARCH CENTRE |
| Address |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA 442001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSunny Prakash Khule |
Mahatma Gandhi Ayurved College Hospital and Research centre wardha |
Room no 41 Department of Kaumarabhritya Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA |
07028490286
sunnyprakashkhule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research centre wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J038||Acute tonsillitis due to other specified organisms. Ayurveda Condition: KANTHASALUKAH/TUNDIKERI, (2) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, (3) ICD-10 Condition:H673||Otitis media in diseases classified elsewhere, bilateral. Ayurveda Condition: KARNASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged 0-2 years of age, either sex, socio-economic status after written informed consent from parents will be taken for this study
2. Children affected by the mentioned symptoms will be taken
a) Karna Vedana (Pain in Ear).
b) Kantha Vedana (Pain in Throat).
c) Pandu Roga (Anemia)
|
|
| ExclusionCriteria |
| Details |
1.Age is more than 2 years.
2.Healthy children.
3.other diseases.
4.Parents not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| . To investigate the concept of “Vedanadhyaya” from “Kashyapa Samhita” and its present therapeutic implications with particular reference to major systems like ENT and blood disorder. |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish clinical parameters for assessing symptoms of chosen diseases under “Vedanadhyaya” in the 0-2 years age group. |
One time |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
|
Brief Summary
|
The
volunteer will be informed about the study protocol. Willing participants will
be randomly selected as per computer generated table. Clinical research format
will be prepared and validated. Prior to the study approval will be taken from
IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After
selection, each participant will be tested individually and selected according
to selection criteria. They are divided into three groups (Karnavedana, Kanthavedana,Pandu Roga) the assess the correlation of specific symptoms according to kashyap samhita of vedanadhyaya with contempory science this study is cross sectional study. The
duration of the observation will be 15 days.Assessment period
during observation – once a time.This study has no follow up. |