| CTRI Number |
CTRI/2025/08/092430 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of untimely eating habits of individual between age group of 20 to 40 years on Digestive health. |
|
Scientific Title of Study
|
A cross sectional study of annavaha stroto dusti lakshana and its association with akala bhojana |
| 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 Preeti Achchhelal Verma |
| Designation |
PG Scholar |
| Affiliation |
R A Podar hospital worli |
| Address |
Department of Sharir kriya, opd no -9 ,M A Podar Hospital ,R A Podar Govt (Ayu) college, worli mumbai-18
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
7700926142 |
| Fax |
|
| Email |
preetiverma2309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sampada Sandeep Sant |
| Designation |
Dean |
| Affiliation |
R A Podar Govt(Ayu) College,Worli,Mumbai-18 |
| Address |
OPD No-09,Sharir Kriya Department ,M A Podar Hospital,R A Podar Govt (Ayu) collage,worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7774845725 |
| Fax |
|
| Email |
sampadasant17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sampada Sandeep Sant |
| Designation |
Dean |
| Affiliation |
R A Podar Govt(Ayu) College,Worli,Mumbai-18 |
| Address |
OPD No-09,Sharir Kriya Department ,M A Podar Hospital,R A Podar Govt (Ayu) collage,worli,Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7774845725 |
| Fax |
|
| Email |
sampadasant17@gmail.com |
|
|
Source of Monetary or Material Support
|
| nil |
| R A Podar Govt(Ayu) college,worli,Mumbai pin code 400018 |
|
|
Primary Sponsor
|
| Name |
R A Podar Govt (Ayu) collage,worli mumbai-18 |
| Address |
R A Podar Govt(Ayu)collage,Worli,Mumbai-18 Dr Annie Besant Road Pin code-400018 |
| 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 Preeti Achchhelal Verma |
Mahadevi Anandilal Podar Govt Hospital |
OPD No-09,Sharir Kriya Department,R A Podar Govt (Ayu) collage,worli,Mumbai-18,Dr Annie Besant Road,Pin code-400018
Mumbai
MAHARASHTRA |
7700926142
preetiverma2309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of institution ,R A Podar Govt Ayu Collage,Worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Persons having akala bhojana |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers having akala bhojana for minimum 2 months
Volunteers having akala bhojana score more than 12 |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Volunteers those who are taking any kind of medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association of akala bhojana lakshana with annavaha strotas dushti lakshan |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the lakshana of annavaha strotas in detail |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/08/2025 |
| 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="8"
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
|
Ahara is described as the foremost pillars among the three pillars of life mentioned in charak samhita. kala bhojana is one of the important ahara etiquette mentioned in samhita. Having ours meal at actual time of hunger can help in proper digestion of food.The ideal time of taking meal is after the appearance of jirna ahara lakshana viz. elimination of faeces and urine,when the mind is clean,when belching is pure without any foul smell or taste, food should be consumed observing the rules and procedure of taking food. This is the ideal time for having food.
Need of study
Taking food at akala is one of the important factors,which causes annavaha stroto dushti, so this topic was selected to study akala bhojana as a preventive measure. In order to avoid these disease, kala bhojana must be followed and awarness should be made about it.
Number of Volunteers-60
Conclusion
The work will be summarized to make final conclusion Observation of result will be concluded with statistical analysis under the heading conclusion with explanation at the end of whole research. |