| CTRI Number |
CTRI/2026/03/105498 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate whether Heme Iron Polypeptide improves haemoglobin levels in pregnant women with iron deficiency anaemia. |
|
Scientific Title of Study
|
Effect of Heme Iron Polypeptide (HIP) in Iron Deficiency Anaemia among Pregnant Women: A Prospective Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/PHARMA-24/2025 Protocol Version 03, 30th January 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandhya Kamat |
| Designation |
Professor and Head of Department |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820165681 |
| Fax |
|
| Email |
drsandhyakamat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmaja Marathe |
| Designation |
Professor Additional |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9619466099 |
| Fax |
|
| Email |
pam2671@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranav Gawande |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S Medical College and KEM Hospital |
| Address |
Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8652100124 |
| Fax |
|
| Email |
gawadepranav1608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lupin Limited, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai – 400055, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Lupin Ltd |
| Address |
Lupin Limited, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai – 400055, Maharashtra, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Pranav Gawande |
Kem Hospital,Mumbai |
Obstetrics and Gynaecology department OPD
Mumbai
MAHARASHTRA |
8652100124
gawandepranav1608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-I , SETH GSMC AND KEM HOSPITAL, MUMBAI |
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 |
Lupiheme, Corcium XT |
Lupiheme: Heme Iron Polypeptide (HIP) {Generic drug (Lupin Ltd)};
Corcium XT: Calcium Carbonate 1250 mg IP [500 mg elemental calcium] + Vitamin D3 2000 IU + Mecobalamin IP 1500 mcg + L-Methyl folate calcium 1mg + Pyridoxal-5-Phosphate IP 20mg {Generic drug (Lupin Ltd)}
Total Duration of intervention : 12 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant woman aged 18 to 40 years. Singleton pregnancy with gestational age between 12 to 18 weeks, confirmed by early trimester ultrasound.
Diagnosed with mild to moderate iron deficiency Anaemia, defined as Haemoglobin (Hb) between 8.0 and 10.9 g/dL and Serum ferritin less than 30 µg/L
Belongs to either of the following two groups:
Iron therapy-naïve: Has not yet received oral or parenteral iron during the current pregnancy
Oral iron intolerant: Has received standard oral iron therapy for greater than 2 weeks and complained of GI intolerance. Willing to provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they have received parenteral iron therapy within the last four weeks; have known hypersensitivity to heme based products or previous reaction to HIP; have anemia due to other causes including hemoglobinopathies, vitamin B twelve deficiency, folate deficiency, chronic renal disease, active infection or inflammation, or chronic blood loss; have poorly controlled type two diabetes defined as random blood glucose equal to or greater than two hundred milligrams per deciliter at screening; have chronic hypertension defined as systolic blood pressure equal to or greater than one hundred forty millimeters of mercury or diastolic blood pressure equal to or greater than ninety millimeters of mercury at screening; have tuberculosis, viral hepatitis, human immunodeficiency virus infection, cirrhosis, malabsorption syndrome, cardiovascular disease, renal disease, autoimmune disease, cancer, or any other clinically significant systemic illness that may interfere with iron absorption or metabolism; or have participated in another interventional clinical study within the past thirty days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in haemoglobin (g/dL) |
From baseline to end of visit 3 (week 12) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in haemoglobin (g/dL) |
At visit 1 and 2 (week 4, 8 respectively from the start of treatment) compared to baseline visit |
| Mean change in serum ferritin |
from baseline to final visit 3 (week 12) |
| Mean change in serum iron |
from baseline to final visit 3 (week 12) |
| The effect of timing of calcium and multivitamin supplements on haemoglobin response by evaluating the mean change in haemoglobin (g/dL) |
from baseline to visit 3 (week 12) |
| change in numerical rating scale score regarding participant’s global assessment of disease |
at each visit |
| Incidents of adverse effects to evaluate the safety and tolerability of HIP |
at each visit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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="0"
Months="9"
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
|
This is a single arm, prospective, open label, interventional study to evaluate the effectiveness, safety, and tolerability of oral Heme Iron Polypeptide in pregnant women with mild to moderate iron deficiency anaemia during the second trimester. Sixty eligible pregnant women between twelve and eighteen weeks of gestation will receive Heme Iron Polypeptide twenty four milligrams once daily for twelve weeks along with routine calcium and multivitamin supplements. Participants will be followed up at baseline, week four, week eight, and week twelve for assessment of haemoglobin, serum ferritin, serum iron, transferrin saturation, and adverse events. The primary outcome is the mean change in haemoglobin from baseline to week twelve. Secondary outcomes include changes in iron parameters, effect of timing of calcium and multivitamin supplementation on haemoglobin response, safety, tolerability, and participant reported outcomes. The study aims to determine whether Heme Iron Polypeptide is an effective and well tolerated alternative for the treatment of iron deficiency anaemia in pregnancy. |