| CTRI Number |
CTRI/2025/11/097020 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional Food Preparation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a food product on haemoglobin level of teenage girls |
|
Scientific Title of Study
|
An Interventional Study on Sensory Evaluation and Analysis of Nutri-balls and its Impact on Haemoglobin Level of Adolescent Girls |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Deepa Mishra |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650453095 |
| Fax |
|
| Email |
deepa1971mishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Deepa Mishra |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650453095 |
| Fax |
|
| Email |
deepa1971mishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Trikona Layek |
| Designation |
Research Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8918101147 |
| Fax |
|
| Email |
trikonalayek@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Home Science, Mahila Mahavidyalaya, Banaras Hindu University, Varanasi- 221005, Uttar Pradesh, India |
| Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India |
| UGC Non-NET Fellowship, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Prof Dr Deepa Mishra |
| Address |
Department of Prasuti Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India |
| Type of Sponsor |
Other [Supervisor] |
|
|
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 |
| Mr Rajan Tiwari |
Sheetala Children School |
Harpalpur Lohta Varanasi
Varanasi
UTTAR PRADESH |
9415293793
rajantiwariflux@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D53||Nutritional anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Intervention |
No intervention will be given to the control group participants and observed for 3 months |
| Intervention |
Nutriballs made up of rice flakes and jaggery |
100 g of Nutriball per day will be given to the trial group participants and observed for 3 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Adolescent girls suffering from any severe disease conditions, such as known cases of Liver diseases, Renal diseases, Diabetes Mellitus, Haemorrhoids, symptoms like Menorrhagia etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant increase in haemoglobin level of adolescent girls. |
After 3 months of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of signs and symptoms of anaemia in adolescent girls. |
After 3 months of intervention. |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
18/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The proposed study will be conducted in four phases. - At first, Nutri-balls will be prepared by mixing rice flakes and jaggery in two different proportions. Sensory evaluation of the two variations will be done by panel members.
- The most acceptable variation obtained through the sensory evaluation process will be selected for interventional purpose and analysed for its nutrient content.
- In the next step, data from adolescent girls regarding their haemoglobin level, clinical signs and symptoms, dietary intake, and other associated factors will be collected. Collected data will be analysed and grading of anaemia will be done as per WHO. Moderately and severely anaemic girls but not less than 5g/dl will be selected for interventional purpose and divided into two groups that are trial and control group. Girls of trial group will be provided 2 Nutri-balls(100g approximately) per day for 3 months.
- After 3 months, reassessment of haemoglobin level, clinical signs and symptoms, dietary intake of the girls of trial group and control group will be performed.
|