| CTRI Number |
CTRI/2024/02/062756 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on antioxidant food components of Ker (Capparis decidua) and Sangri (Prosopis cineraria) indigenous vegetables from of Rajasthan. |
|
Scientific Title of Study
|
A study on Ker (Capparis decidua) and Sangri (Prosopis cineraria) indigenous vegetables from the arid areas of Rajasthan as antioxidant food components in diets. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragya |
| Designation |
student |
| Affiliation |
Dr BMN college Of Home science, 338 Rafi Ahmed Kidwai road, Matunga, Mumbai, Maharashtra |
| Address |
Dr BMN college Of Home science, 338 Rafi Ahmed Kidwai road, Matunga, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400019
India |
| Phone |
8619666361 |
| Fax |
|
| Email |
pragyadhaka6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhvi Sathe |
| Designation |
Assissstant Professor |
| Affiliation |
MMP Shah Womens college of Arts and Commerce |
| Address |
Head department at Smt. Maniben MP Shah Womens College of Arts and Commerce, Matunga, Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhvi Sathe |
| Designation |
Assisstant Professor |
| Affiliation |
MMP Shah Womens college of Arts and Commerce |
| Address |
Head of department at Smt. Maniben MP Shah Womens College of Arts and Commerce, Matunga, Mumbai
Mumbai
MAHARASHTRA
400019
India |
| Phone |
9892544080 |
| Fax |
|
| Email |
misathe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr BMN college Of Home science, 338 Rafi Ahmed Kidwai road, Matunga, Mumbai, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Pragya |
| Address |
Dr BMN college of Home Science,338, Rafi Ahmed Kidwai Rd, Matunga East, Mumbai, Maharashtra 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 |
| Pragya |
Dr BMN college of Home Science |
Chemistry lab, Msc CND department of DR BMN college of Home science.
Mumbai
MAHARASHTRA |
8619666361
pragyadhaka6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seva Mandal Education Society Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
The study will include middle age women who cook
from households residing in districts like Jhunjhunu and Chirwa the arid areas of Rajasthan,
where Ker (Capparis decidua) and Sangri (Prosopis cineraria) are indigenous vegetables.
Dietary Habits Households that include Ker and Sangri at least once a month.
Households could be from any religion, caste or economic status |
|
| ExclusionCriteria |
| Details |
Respondents from other villages or districts in Rajasthan.
Younger age women who have recently started cooking |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The findings of this study will be able to give the total polyphenol content
and the antioxidant capacity of Capparis decidua and Prosopis cineraria. Few studies suggest
that Ker and Sangri have various health benefits of therapeutic role. However, no mechanisms
have been documented. Thus, this study will help to determine antioxidant and phenolic content
of these plant products and the potential for use of Ker and Sangri in different recipes for
normal and therapeutic use. The recipes standardization in the study will introduce these
indigenous ingredients to multiple communities thus benefiting all |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional benefits of the standard recipes would be known. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
25/02/2024 |
| 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
|
AIM- To determine the total phenolic content and antioxidant capacity of 100 g of Capparis decidua (Ker) and Prosopis cineraria (Sangri) and modification of traditional preparations using the ingredients to suit certain disease conditions
OBEJECTIVES-
To determine the uses of Ker and Sangri in traditional recipes and the local beliefs regarding their health benefits.
To standardize two traditional recipes using both the ingredients and modify the recipes suitable for certain disease conditions such as diabetes and hypertension.
To determine total phenolic content of Prosopis cineraria (Sangri) and Capparis decidua (Ker) using Folin Ciocalteu redox method.
To determine their antioxidant capacity using 2,2-Diphenyl-1-picrylhydrazyl (DPPH) radical scavenging activity and FRAP assay (ferric reducing ability of plasma).
Null Hypothesis:
The indigenous vegetables Ker and Sangri show no difference in the total phenolic content and antioxidant capacity.
METHODOLOGY- Study Design: Cross- Sectional Study Sampling Method - Purposive Sampling Sample size- women who have been cooking using traditional methods, age 35-55 years old
|