| CTRI Number |
CTRI/2025/01/079156 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring the link between vitamin B 12 Levels and Urdhwag Amlapitta in relation to GERD:a case control study |
|
Scientific Title of Study
|
Case control study to determine the association between levels of vitamin B12 and Urdhwag Amlapitta with special reference to GERD |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMadhuri Shivajirao Patil |
| Designation |
PG scholar |
| Affiliation |
Shree saptashrugi ayurved Mahavidyalaya and hospital kamalnagar hirawadi panchvati Nashik |
| Address |
Kayachikitsa OPD no 2 ground floor shree saptashrugi ayurved mahavidyalaya and hospital kamalnagar hirawadi panchvati, Nashik
Kayachikitsa OPD no 2 ground floor shree saptashrugi ayurved mahavidyalaya and hospital kamalnagar hirawadi panchvati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9975886960 |
| Fax |
|
| Email |
madhuripatil3009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKaveri Kiran Shinde |
| Designation |
Associate Professor |
| Affiliation |
Shree saptashrugi ayurved mahavidyalaya and hospital kamalnagar Hirawadi Panchavati Nashik |
| Address |
OPD no 2 ground floor Department of kaychikitsa shree saptashrugi ayurved mahavidyalaya and hospital kamalnagar hirawadi panchvati, Nashik
OPD no 2 ground floor, Department of kaychikitsa shree saptashrugi ayurved mahavidyalaya and hospital kamalnagar hirawadi panchvati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8600274860 |
| Fax |
|
| Email |
drkaveripatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri Shivajirao Patil |
| Designation |
PG Scholar |
| Affiliation |
Shree saptashrugi ayurved Mahavidyalaya and hospital kamalnagar Hirawadi Panchavati Nashik |
| Address |
OPD no 2 ground floor Department of kaychikitsa shree saptashrugi ayurved mahavidyalaya and hospital kamalnagar hirawadi panchvati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9975886960 |
| Fax |
|
| Email |
madhuripatil3009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree saptashrugi ayurved mahavidyalaya and hospital kamalnagar Hirawadi Panchavati Nashik Maharashtra India Pin code 422003 |
|
|
Primary Sponsor
|
| Name |
Shree saptashrugi ayurved Mahavidyalaya and hospital |
| Address |
Department of kaychikitsa OPD no 2 Shree saptashrugi ayurved Mahavidyalaya and hospital kamalnagar Hirawadi Panchavati Nashik Maharashtra India Pin code 422003 |
| 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 |
| DrMadhuri Shivajirao Patil |
Shree saptashrugi ayurved Mahavidyalaya and hospital |
Department of kaychikitsa,opd no.2 Shree saptashrugi ayurved Mahavidyalaya and hospital kamalnagar Hirawadi Panchavati Nashik
Nashik
MAHARASHTRA |
9975886960
madhuripatil3009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree saptashrugi ayurved Mahavidyalaya and hospital kamalnagar Hirawadi Panchavati Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms of Urdhwag Amlapitta
irrespective of gender
2.Patients willing for test and giving written consent
3.Patients from all socioeconomic status
|
|
| ExclusionCriteria |
| Details |
i.Patients below 18 years and above 60 years
ii.
Patients of Adhog Amlapitta
iii.
Patients
having
hepatic
disorders
&
other
complications
iv.
Patients suffering from any infectious diseases,
surgical entity
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
There is association between
vitamin B12 levels and Urdhwag amlapitta |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no association between vitamin B12 levels and Urdhwag Amlapitta |
6 months |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Objectives:
1) To study literature regarding vitamin B12
2) To study literature regarding Urdhwag Amlapitta in
Ayurveda
3) To study literature regarding GERD
Participants - Cases 144 were patients aged above 18 years of either sex, diagnosed with Urdhwag Amlapitta attending outpatient department (OPD). The controls 72 included
hospital controls from same hospitals.
Exposure status was assessed through Case Record
Form (CRF), Urdhwag Amlapitta assessment Questionnaires, interview with patients.
Conclusion:
will be drawn on the basis of Observation & discussion
whether the Vitamin B12 levels have relation with Urdhwag Amlapitta.
Summary:
All the data will be summarized after obtaining the result and
conclusion
Result :
Statistical data will be analysed by Suitable
statistical descriptive test
Ethical Considerations- The study will be conducted in accordance with ethical guidelines and with informed consent from participants. |