| CTRI Number |
CTRI/2019/07/020092 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
07/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the Proportion of Gastro Esophageal Reflux Disease (Erigunmam)- in AAGHIM |
|
Scientific Title of Study
|
Prevalence of Gastro Esophageal Reflux Disease (Erigunmam)- a cross sectional study in AAGHIM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shakeena Parveen A |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate
Department of General Medicine
Government Siddha Medical College
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9094598666 |
| Fax |
|
| Email |
shakeen12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ujjeevanam G |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Professor
Department of General Medicine
Government Siddha Medical College
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9884175653 |
| Fax |
|
| Email |
ujjeevanam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shakeena Parveen A |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate
Department of General Medicine
Government Siddha Medical College
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9094598666 |
| Fax |
|
| Email |
shakeen12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College
Arumbakkam
Chennai 600106
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College
Arumbakkam
Chennai 600106
Tamil Nadu |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Shakeena Parveen A |
Arignar Anna Government Hospital of Indian Medicine |
Room no 2
Ground floor
Siddha Department
Arumbakkam
Chennai 600106
Tamil Nadu
Chennai
TAMIL NADU |
9094598666
shakeen12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both gender with age between 20 to 70 years attending outpatient department at Arignar Anna Government Hospital of Indian Medicine chennai will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with known history of malignancies and other complications like oesophagitis will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of Gastro Esophageal Reflux Disease (Erigunmam) using F-scale (frequency scale) scoring among patients of age between 20 to 70 years attending outpatient department at Arignar Anna Govt Hospital of Indian Medicine Chennai. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of Gastro Esophageal Reflux Disease (Erigunmam) using F-scale (frequency scale) scoring among patients of age between 20 to 70 years attending outpatient department at Arignar Anna Govt Hospital of Indian Medicine Chennai.
|
90 days |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a cross sectional study to estimate the prevalence of gastro esophageal reflux disease (erigunmam) using frequency scale scoring (f scale) among patients of age between 20 to 70 years attending outpatient department at Arignar Anna Government Hospital of Indian Medicine chennai. Frequency scale (f scale) consists of 12 questions to assess the frequency of the symptoms of gastro esophageal reflux disease. If the patient scores more than 7 points then gastro esophageal reflux disease is considered to be present.
|