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Efficacy and Safety Study Tablet ( Irpo- FA®) in Pregnant Women

Efficacy and Safety Study of Fixed Dose Combination Tablet of Iron Polymaltose and Folic Acid (Tablet Irpo- FA®) in Pregnant Women with Iron Deficiency Anaemia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT201610197978N3
Enrollment
50
Registered
2016-10-31
Start date
2015-04-15
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency & Folic acid Deficiency anemia. Iron deficiency anaemia, unspecified & Folate deficiency anaemia, unspecified

Interventions

Each patient received irpo-FA (combination tablet of Iron Polymaltose (100mg elemental iron) & 0.35 mg folic acid oral tablets O. D, following the instructions as chew the tablets on empty stomach, 1
Treatment - Drugs

Sponsors

Nabiqasim Industries (Pvt) Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Pregnant Women in second or third trimester or after 12 weeks of pregnancy, Hb: = 10. 5g/dl after first trimester and serum ferritin levels are below than normal (less than 35 µg/l) Exclusion Criteria: Patient with a history of non-compliance with iron therapy or allergic to iron preparation.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Increase of 1g/dl Hb with 100-200mg/day elemental iron. Timepoint: 2 weeks, 1 month, 2 months and three months after initiation of oral iron therapy. Method of measurement: C. B. C, Ferritin, iron profile tests.

Secondary

MeasureTime frame
Gastrointestinal adverse events. Timepoint: At every visit and Follow up checkups. Method of measurement: Patient monitoring & Follow up calls to patients.

Countries

Pakistan

Contacts

Public ContactSalman Rahim

Nabiqasim Industries (Pvt) Ltd.

salman.rahim@nabiqasim.com009221 32636313

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026