| CTRI Number |
CTRI/2026/03/106081 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the safety and effectiveness of Ferronomic Plus with standard oral iron tablets in pregnant women with iron deficiency anaemia |
|
Scientific Title of Study
|
An Open Label, Prospective, Interventional, Randomized, Multicentre, Two Arm Study to Evaluate Efficacy and Safety of Ferronomic Plus (Lactoferrin 50 mg + Disodium Guanosine 5-Monophosphate 5 mg + Ferrous Bisglycinate 30 mg + Folic Acid 200 mcg) in Comparison to Conventional Oral Iron Formulation in Pregnant Female with Iron Deficiency Anaemia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/2025/26, Version No. 00 and Date Sep 24, 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Medchal
TELANGANA
500062
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekhara Reddy Tamma |
| Designation |
Managing Director |
| Affiliation |
Clinwave Research Pvt. Ltd. |
| Address |
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
TELANGANA
500062
India |
| Phone |
7989233379 |
| Fax |
|
| Email |
dr.sekhar@clinwave.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Shah |
| Designation |
DGM- Medical Affair & Pharmacovigilance |
| Affiliation |
Frimline Pvt. Ltd. |
| Address |
511, 5th Floor, Circle P Building, ISCON Elegance, Near Jain Temple, Prahlad Nagar Cross Roads, S. G. Highway.
Ahmadabad
GUJARAT
380015
India |
| Phone |
9879540270 |
| Fax |
|
| Email |
harsh.shah@larenon.com |
|
|
Source of Monetary or Material Support
|
| Frimline Pvt. Ltd.,
511, 5th Floor, Circle P Building, ISCON Elegance, Near Jain Temple, Prahlad Nagar Cross Roads, S. G. Highway, Ahmedabad-380015, Gujarat.
|
|
|
Primary Sponsor
|
| Name |
Frimline Pvt. Ltd. |
| Address |
511, 5th Floor, Circle P Building, ISCON Elegance,
Near Jain Temple, Prahlad Nagar Cross Roads,
S. G. Highway, Ahmedabad-380015, Gujarat. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seema Upadhyay |
GSVM Medical College |
Department of Obstetrics & Gynaecology, LLR Hospital,
Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH |
7754070807
pitrials.gsvm@gmail.com |
| Dr Isukapalli Vani |
King George Hospital |
Department of Gynaecology and Obstetrics, Andhra Medical College, Maharanipeta, Visakhapatnam-530002.
Visakhapatnam
ANDHRA PRADESH |
9346627652
drivaniresearch@gmail.com |
| Dr Smriti Gupta |
Subharti Medical College and Hospital |
Department of Obstetrics & Gynaecology, Subharti Puram,
NH-58, Delhi-Haridwar Bypass Road, Meerut-250005.
Meerut
UTTAR PRADESH |
9837027249
gupta_smriti_80@yahoo.in |
| Dr Swapnita Hota |
Sunshine Hospital (A Unit of Sai Sidhi Swagat Health Services Pvt. Ltd.) |
Research Room, Laxmi Sagar Square, Puri-Cuttack Road, Bhubaneswar-751006.
Khordha
ORISSA |
8763240943
drswapnita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| CUTM-Independent Ethics Committee, Centurion University of Technology and Management - Sunshine Hospital (A Unit of Sai Sidhi Swagat Health Services Pvt. Ltd.) |
Submittted/Under Review |
| Ethics Committee, GSVM Medical College |
Submittted/Under Review |
| Institutional Ethics Committee, King George Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Subharti Medical College and Hospital |
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 |
| Intervention |
Ferronomic Plus (Lactoferrin 50 mg + Disodium Guanosine 5-Monophosphate 5 mg + Ferrous Bisglycinate 30 mg + Folic Acid 200 mcg Tablets) |
Subjects will be advised to take one tablet twice daily orally, swallowed with water around same time every day for 60 days. |
| Comparator Agent |
Ferrous Ascorbate 100 mg + Folic Acid 1.5 mg Tablets |
Subjects will be advised to take one tablet twice daily orally, swallowed with water around same time every day for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects willing to provide written informed consent.
2. Subjects are willing and able to comply with all the protocol requirements including availability for all scheduled study visits.
3. Subjects with physiological course of pregnancy, singleton pregnancy, gestational age greater than 12 weeks and smaller than 36 weeks at the time of screening visit.
4. Subjects with hemoglobin (Hb) value of smaller than 10 g per dL at screening visit.
5. Subjects with serum iron smaller than 50 mcg per dL and serum ferritin greater than 100 ng per mL at screening visit. |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of allergic or hypersensitive reaction or intolerance to any of the ingredients of the study medication.
2. Subjects with gestational (such as hypertension, gestational diabetes) or pre-existent maternal diseases (such as thyroid dysfunctions, pituitary diseases, nutritional diseases, liver pathologies and fetal abnormalities (such as microcephaly, IUGR).
3. Subject has condition or is in a situation which, in the investigator’s opinion, may have put the subject at a significant risk, may have confounded study results, or may have interfered significantly with the subject’s participation in the study.
4. Subjects with known history of macrocytic or megaloblastic anemia due to vitamin B12 or folate deficiency.
5. Subjects with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
6. Subject has used an investigational formulation in the 3 months prior to screening visit.
7. Subjects with suspected inability or unwillingness to comply with the study procedures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin levels from baseline to end of study visit (Day 60). |
Visit 1 - Screening or Baseline visit and
Visit 4 - End of Study (EOS) visit / Day 60 ± 2 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in hemoglobin levels from baseline to day 30. |
Visit 1 - Screening or Baseline visit and
Visit 3 - Follow up visit / Day 30 ± 2 days. |
| Change in serum ferritin, serum iron and total iron-binding capacity (TIBC) levels from baseline to day 30 and day 60. |
Visit 1 - Screening or Baseline visit,
Visit 3 - Follow up visit / Day 30 ± 2 days and
Visit 4 - End of Study (EOS) visit / Day 60 ± 2 days. |
| Adverse events and serious adverse events reported during the study. |
Throughout the study. |
| Changes in clinical laboratory parameters from baseline to end of study visit. |
Visit 1 - Screening or Baseline visit and
Visit 4 - End of Study (EOS) visit / Day 60 ± 2 days. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
16/03/2026 |
| 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) |
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
|
A total of 150 female subjects with pregnancy at geographically
distributed centres in India will be enrolled in this clinical study to
evaluate the efficacy and safety of Ferronomic Plus (Lactoferrin 50 mg +
Disodium Guanosine 5-Monophosphate 5 mg + Ferrous Bisglycinate 30 mg + Folic
Acid 200 mcg) in comparison to conventional oral Iron formulation. Female
subjects with physiological course of pregnancy, singleton pregnancy,
gestational age > 12 weeks and < 36 weeks, hemoglobin (Hb) value of <
10 g/dL, serum iron < 50 mcg/dL and serum ferritin > 100 ng/mL at
screening visit will be considered for enrollment in this study. The enrolled subjects
will be allocated to either of the 2 study groups according to the computer-generated
randomization plan in a 1:1 ratio. |