| CTRI Number |
CTRI/2025/07/091006 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Preventing Iron Deficiency in Women Using an Iron-Based Cosmetic Bindi |
|
Scientific Title of Study
|
Transdermal Iron Supplementation as Bindi for Women: A Novel Concept |
| 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 Ruchita Dixit |
| Designation |
Professor |
| Affiliation |
Shri Shankaracharya Institute of Medical Sciences |
| Address |
Department of Community medicine,
Shri Shankaracharya Institute of Medical Sciences, Junwani Road, Bhilai, Durg, Chhattisgarh
Durg
CHHATTISGARH
490020
India |
| Phone |
7887488603 |
| Fax |
|
| Email |
drruchitadixit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchita Dixit |
| Designation |
Professor |
| Affiliation |
Shri Shankaracharya Institute of Medical Sciences |
| Address |
Department of Community medicine,
Shri Shankaracharya Institute of Medical Sciences, Junwani Road, Bhilai, Durg, Chhattisgarh
Durg
CHHATTISGARH
490020
India |
| Phone |
7887488603 |
| Fax |
|
| Email |
drruchitadixit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchita Dixit |
| Designation |
Professor |
| Affiliation |
Shri Shankaracharya Institute of Medical Sciences |
| Address |
Department of Community medicine,
Shri Shankaracharya Institute of Medical Sciences, Junwani Road, Bhilai, Durg, Chhattisgarh
Durg
CHHATTISGARH
490020
India |
| Phone |
7887488603 |
| Fax |
|
| Email |
drruchitadixit@gmail.com |
|
|
Source of Monetary or Material Support
|
| IIT Bhilai Innovation and Technology Foundation |
|
|
Primary Sponsor
|
| Name |
IIT Bhilai Innovation and Technology Foundation |
| Address |
GEC Campus Sejbahar
Raipur Chhattisgarh 492015 India
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchita Dixit |
Shri Shankaracharya Institute of Medical Sciences |
Department of Community Medicine Junwani Road Bhilai Durg Chhattisgarh 490020
Durg
CHHATTISGARH |
7887488603
drruchitadixit@gmail.com |
| Dr Swarnali Das Paul |
Kamla Institute of Pharmaceutical Sciences |
Animal House,Under Department of Pharmacy Junwani, Bhilai-490020. Chhattisgarh ( India)
Durg
CHHATTISGARH |
9977258200
swarnali34@gmail.com |
| Dr Ruchita Dixit |
Rural Health Training Centre Shri Shankaracharya Institute of Medical Sciences |
Department of Community medicine Beloudi 491001
Durg
CHHATTISGARH |
7887488603
drruchitadixit@gmail.com |
| Dr Swarnali Das Paul |
Shri Shankaracharya College of Pharmaceutical Sciences |
Laboratory of Department of Pharmacy, Junwani Road Bhilai Durg Chhattisgarh 490020
Durg
CHHATTISGARH |
9977258200
swarnali34@gmail.com |
| Dr Ruchita Dixit |
Shri Shankaracharya Institute of Medical Sciences |
Central Clinical laboratory, under department of Biochemistry Junwani Road Bhilai Durg Chhattisgarh 490020
Durg
CHHATTISGARH |
7887488603
drruchitadixit@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SSIMS |
Approved |
| nstitutional Animal Ethics Committee (IAEC), Shri Shankaracharya Professional University, Bhilai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Patch |
Appearance: Identical in size, shape, color, and texture to the active iron patch.
Odor and Feel: Mimics the sensory characteristics (odor, stickiness, texture) of the active patch.
Composition: Contains all the same base materials as the active patch—such as:
Backing layer
Adhesive matrix
Any non-iron excipients (e.g., polymers, hydrogels, permeation enhancers)
Key Difference: Does not contain any iron (elemental iron or iron salts).
Inert Fillers: May include hydrogel, polymer base, or saline-based substances to match the physical feel and application experience.
Packaging and Labeling: Identical to active patches to maintain blinding.
Application: Applied in the same body site and frequency as the active patch.
|
| Intervention |
transdermal iron patch |
Iron Patch
Type: Transdermal patch for iron supplementation.
Active Ingredient: Contains elemental iron (e.g., ferrous sulfate or ferric pyrophosphate).
Mechanism: Delivers iron through the skin into systemic circulation.
Matrix: Uses a polymeric or hydrogel base to control release.
Application: Applied to clean, dry skin, forehead
Target Use: For individuals with iron deficiency anemia.
Safety: Skin-safe, hypoallergenic, designed to minimize irritation.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.women in reproductive age group, with and without Iron deficiency anemia
2.who give consent for the trial |
|
| ExclusionCriteria |
| Details |
1.Women seriously ill
2. Pregnant women
3. Not giving consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Development of an effective and safe transdermal iron supplementation method
Reducing hospital admission and hospital stays due to iron deficiency anemia in women
Reducing the burden on the healthcare system
Overall reducing mortality and morbidity
Improving the health of the community
Better productivity
Providing quality services to women
|
continous ongoing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
NIL |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="520"
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)
|
01/09/2025 |
| 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 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
|
Title: Transdermal Iron Supplementation as Bindi for Women A Novel Concept Objective:
To develop and evaluate the effectiveness of transdermal iron supplementation through a bindi a colored sticker dot worn on the forehead for women Methodology: -
Laboratory experiments to identify the best iron salt and dosage for transdermal absorption -
Preclinical trials on animal models to assess safety and efficacy -
Phase I clinical trial on 35 healthy women to assess safety and tolerability -
Phase II clinical trial on 175 women with iron deficiency anemia to assess efficacy -
Phase III randomized controlled trial on 310 women with iron deficiency anemia to confirm efficacy and safety -
Phase IV postmarketing trial to assess longterm safety and effectiveness Expected Outcomes: -
Development of an effective and safe transdermal iron supplementation method -
Reducing hospital admission and hospital stays due to iron deficiency anemia in women -
Reducing the burden on the healthcare system -
Overall reducing mortality and morbidity -
Improving the health of the community -
Better productivity -
Providing quality services to women Significance:
Iron deficiency anemia is a significant public health concern affecting millions of women worldwide. This novel approach offers a convenient noninvasive and potentially more effective solution. Timeline: 1 year 6 months Funding: 5 lakh rupees Resources available: Researchers laboratory staff clinical trial participants tertiary care hospital rural health training centre and pharmaceutical laboratory facilities Keywords: Bindi Iron Supplementation Novel approach Anemia Transdermal patch Clinical trial |