| CTRI Number |
CTRI/2025/07/090055 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Safety and Effectiveness of Bizfer XT Tablet (Iron, Zinc, Folic Acid, and Vitamin B12) in Improving Hemoglobin Levels in Patients with Iron Deficiency Anemia |
|
Scientific Title of Study
|
A Prospective, Single-Arm Study Evaluating the Efficacy and Safety of Bizfer XT(Ferrous Bisglycinate 60mg plus Zinc Bisglycinate 15mg plus Folic Acid 1mg plus Methylcobalamin 500mcg tablet) for the treatment of Iron Deficiency Anemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JB-25-05 Version 1.0 Dated 10 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Head – Medical Services |
| Affiliation |
Clinexcel Research |
| Address |
297/301, SoBo Center, South Bopal, ahmedabad.
Ahmadabad
GUJARAT
380058
India |
| Phone |
07600012192 |
| Fax |
|
| Email |
drjayesh@clinexcelresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jay Savai |
| Designation |
Sr. manager- Medical Affairs |
| Affiliation |
J. B. chemicals & pharmaceuticals LTD |
| Address |
Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi
Buldana
MAHARASHTRA
400025
India |
| Phone |
9833100642 |
| Fax |
|
| Email |
Jay.Savai@jbpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jay Savai |
| Designation |
Sr. manager- Medical Affairs |
| Affiliation |
J. B. chemicals & pharmaceuticals LTD |
| Address |
Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi
Buldana
MAHARASHTRA
400025
India |
| Phone |
9833100642 |
| Fax |
|
| Email |
Jay.Savai@jbpharma.com |
|
|
Source of Monetary or Material Support
|
| J. B. chemicals & pharmaceuticals LTD., Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi, Mumbai 400025 |
|
|
Primary Sponsor
|
| Name |
J. B. chemicals & pharmaceuticals LTD. |
| Address |
Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi, Mumbai 400025 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sameer Thakkar |
Brinda Womens Hospital |
B/h. Gordhandas Trust Hospital, Nr. Sanjeevani Hospital,Vastrapur, 380014
Ahmadabad
GUJARAT |
9428998999
samirthakkar2009@gmail.com |
| Dr Chintan Patel |
Aatman Hospital |
Basement , Clinical Research Department,5, Anveshan Row House, Opp Umiya Mata Mandir Bopal-Ghuma Main Road, Bopal - 380058 India
Ahmadabad
GUJARAT |
9825182251
drchintan.cr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aatman Hospital Aatman Hospital |
Approved |
| Institutional Ethics Committee Aatman Hospital Aatman Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brizfer-XT® |
Bizfer-XT® (Ferrous Bisglycinate 60mg+ Zinc Bisglycinate 15mg + Folic Acid 1mg + Methylcobalamin 500mcg) tablet once daily for 56 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects aged 18 to 40 years who are non-pregnant and non-lactating, confirmed by medical history and/or a negative urine pregnancy test.
2. Confirmed diagnosis of iron deficiency anemia (IDA), defined as:
a. Hemoglobin (Hb) level between 8–11.9 g/dL, and
b. Serum ferritin less than 30 ng/mL, and
c. Transferrin saturationless than 20%.
3. Willing to use effective contraception during the study period (if applicable).
4. Willing and able to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Known history of any chronic uncontrolled systemic illnes.
2. Pregnant or lactating women, or those planning pregnancy during the study period
3. Known hypersensitivity or intolerance to iron, folic acid, methylcobalamin, zinc, or any component of the study medication.
4. Anemia due to non-iron deficiency causes, such as:
a)Hemolytic anemia
b)Aplastic anemia
c)Megaloblastic anemia unrelated to iron deficiency
d)Thalassemia or other hemoglobinopathies
5. Known history of chronic inflammatory conditions (e.g., rheumatoid arthritis, IBD) that may affect iron metabolism.
6. History of malabsorption syndromes (e.g., celiac disease, bariatric surgery) unless well-controlled.
7. Use of parenteral/oral iron therapy or blood transfusion in the past 12weeks.
8. Current use of other iron supplements or multivitamins containing iron.
9. Participation in another clinical trial within the past 30 days.
10. Any condition that, in the investigator’s judgment, may compromise safety, compliance, or study integrity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in hemoglobin (Hb) levels from baseline to the end of treatment |
From baseline to end of study day 56 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in serum ferritin levels |
From baseline to end of study day 56 |
| Mean change in serum iron and transferrin saturation (TSAT) |
From baseline to end of study day 56 |
| Change in fatigue symptoms as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. |
From baseline to end of study day 56 |
| Percentage of participants achieving target Hb levels (Less than or equal to12 g/dL) by end of treatment. |
At end of study day 56 |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the study drug. |
From baseline to end of study day 56 |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
13/07/2025 |
| 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="9"
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
|
This is a prospective, single-arm, open-label clinical study designed to evaluate the efficacy and safety of Bizfer-XT® tablets (containing Ferrous Bisglycinate 60 mg, Zinc Bisglycinate 15 mg, Folic Acid 1 mg, and Methylcobalamin 500 mcg) in the treatment of iron deficiency anemia (IDA) in adult women. The study will enroll non-pregnant, non-lactating female subjects aged 18 to 40 years who have a confirmed diagnosis of IDA, defined by hemoglobin levels between 8–11.9 g/dL, serum ferritin levels less than 30 ng/mL, and transferrin saturation less than 20%. Eligible subjects will receive one Bizfer-XT® tablet daily for a total duration of 8 weeks. Study visits will occur at baseline (Day 0), Week 4 (Day 28 ± 2), and Week 8 (Day 56 ± 2). The primary objective is to assess the mean change in hemoglobin levels from baseline to Week 8. Secondary objectives include evaluation of changes in serum ferritin and transferrin saturation, along with the assessment of safety and tolerability of the study medication. The results of this study aim to support the clinical utility of Bizfer-XT® in managing iron deficiency anemia among women of reproductive age |