| CTRI Number |
CTRI/2024/12/078323 [Registered on: 19/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to find structural involvement and changes in the abdomen of
patients having Dakodara |
|
Scientific Title of Study
|
A cross sectional study to find structural involvement and changes in the abdomen of
patients having Dakodara with the help of CT scan. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Uttamrao Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved And Research Centre |
| Address |
PDEAS College of ayurved and research centre sharir rachana
department ground floor nigdi pune Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8888002612 |
| Fax |
|
| Email |
gauravgc1050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Bhanage |
| Designation |
Assistant Professor |
| Affiliation |
PDEAS College of Ayurved And Research Centre |
| Address |
PDEAS College of ayurved and research centre sharir rachana
department ground floor nigdi pune Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9130099663 |
| Fax |
|
| Email |
mmbhanage@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Bhanage |
| Designation |
Assistant Professor |
| Affiliation |
PDEAS College of Ayurved And Research Centre |
| Address |
PDEAS College of ayurved and research centre sharir rachana
department ground floor nigdi pune Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9130099663 |
| Fax |
|
| Email |
mmbhanage@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS college of ayurved and research centre nigdi, pune, Maharashtra , India , Pin code - 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAS college of ayurved and research centre nigdi pune |
| Address |
PDEAS College of ayurved and research centre sharir rachana
department ground floor nigdi pune Maharashtra 411044
India |
| Type of Sponsor |
Private 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 Gaurav Uttamrao Chaudhari |
Ayurved Rugnalaya and sterling and multispeciality hospital |
OPD No. 117 ,
Kayachikitsa
Department , Sector 27,
Nigdi Pradhikaran ,
Pune , Maharashtra
Pune
MAHARASHTRA |
8888002612
gauravgc1050@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson ethics committee college of Ayurved and research centre Akurdi Pune 44 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K90-K95||Other diseases of the digestive system. Ayurveda Condition: UDARA/UDARAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Prediagnosed patient of dakodara who had done CT scan will be selected.
2) Age group 30-70 years,irrespective of sex,religion,socioeconomic status and occupation. |
|
| ExclusionCriteria |
| Details |
1) Patient of intestinal perforation,septicemia,Road traffic accident involving trauma to
abdomen,pregnancy.
2)Known case of HIV and TB will be excluded . |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the structural involvement and changes in the abdomen of patient having Dakodara. |
4 Weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
05/01/2025 |
| 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="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
|
Udara roga denotes the generalized distension of abdomen of various etiology . In Ayurveda , mandagni causes improper digestion of ingested food which leads to Udara roga. Agni dosha and mala vriddhi causes defective of Prana, agni & Apana and obstruction of the upward and downward channels of circulation. The defective doshas get fixed between skin and muscle tissue and causes distension of the abdomen resulting in Udara roga. The cardinal features are Kukshiadhmana, Mandagni, Krushagatra,Karapadashopha . If proper treatment is not given or hetu is continued, then by paripaka all types of udara will developed into dakodara. Dakodara (Ascites) causes abdominal distension with fullness in the flanks, shifting dullness on percussion and a fluid thrill when the dakodara is marked. |