| CTRI Number |
CTRI/2025/07/091641 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Cross sectional study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on the Eating Habits and Use of Traditional Green Leafy Vegetables by the Aagri People in Thane District and How These Vegetables May Help Health" |
|
Scientific Title of Study
|
A Study on the Dietary Pattern and Consumption of Indigenous Green Leafy Vegetables in the Aagri Community of Makunsar Village, Thane District, and the phytochemical screening of the natural crude extracts for their antioxidant properties
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi Pandey |
| Designation |
Student |
| Affiliation |
Dr. BMN College of Home science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9529923739 |
| Fax |
|
| Email |
pandeymansi672@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of Department |
| Affiliation |
Dr. BMN College of Home science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Sengupta |
| Designation |
Head of Department |
| Affiliation |
Dr. BMN College of Home science |
| Address |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892415789 |
| Fax |
|
| Email |
rupali@bmncollege.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mansi Pandey |
| Address |
338, Rafi Ahmed Kidwai Road, Matunga, Mumbai-400019 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rupali Sengupta |
Dr. BMN College of Home science |
Dr. BMN College of Home Science, Department of Clinical Nutrition and Dietetics, 338 R.A. Kidwai Marg, Matunga East, Mumbai, Maharashtra 400019
Mumbai
MAHARASHTRA |
9892415789
rupali@bmncollege.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals with no health issues |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 18 to 50 years
Permanent residents of Makunsar village
Willing to participate |
|
| ExclusionCriteria |
| Details |
Participants with medical conditions requiring dietary restrictions excluding GLVs
Pregnant and lactating women
Individuals unwilling to participate or unable to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Documentation of dietary patterns, frequency, seasonal consumption, and traditional significance of indigenous green leafy vegetables among the Aagri community. Phytochemical screening of the natural crude extracts for antioxidant and bioactive compounds. |
Data collected and analyzed within 6-7 months of the study duration.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of awareness and traditional knowledge regarding the nutritional benefits and cultural importance of indigenous green leafy vegetables among participants. |
Within 6-7 months of the study duration |
|
|
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)
|
05/08/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a descriptive cross-sectional study conducted in the Aagri community of Makunsar village, Thane district. The study aims to document the dietary patterns, frequency, seasonal consumption, and traditional significance of indigenous green leafy vegetables (GLVs) consumed by the community. It will also identify and classify these GLVs taxonomically and perform phytochemical screening to detect primary metabolites, such as carbohydrates, proteins, and lipids, as well as secondary metabolites, including alkaloids, flavonoids, and phenolics with antioxidant properties. Data collection and laboratory analysis will be conducted over approximately 6 to 7 months. The study will include 200 participants aged between 18 and 50 years. |