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Clinical Trials/CTRI/2019/01/017303
CTRI/2019/01/017303
Completed
Phase 3

To evaluate the efficacy, safety, and tolerability of Abhraloha in women compared with oral Ferrous Ascorbate in iron deficiency anemia - Randomized controlled, parallel group, assessor blind clinical trial.

Shree Dhootapapeshwar Limited0 sites57 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Shree Dhootapapeshwar Limited
Enrollment
57
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
March 11, 2020
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Women \>18 years to \<65 years old.
  • •2\.Women diagnosed with iron deficiency anemia (criteria stated in Annexure 1\) and Hb\<\=10 g/dL and \>7gm/dl and serum ferritin \<30ug/L
  • •3\.Women in postpartum period 10 days after delivery
  • •4\.Women with negative urine pregnancy test.

Exclusion Criteria

  • •1\.Women with significant vaginal bleeding (estimated blood loss greater than 100 cc) in the 24 hours prior to randomization
  • •2\.Women with a history of anemia other than iron deficiency anemia or anemia due to blood loss due to delivery.
  • •3\.Women on current treatment with myelo suppressive therapy or asthma therapy
  • •4\.Women with recent blood transfusions, or erythropoietin within 3 months prior to screening.
  • •5\.Women with history of bleeding tendency, history of blood transfusion within the prior 120 days, hemoglobinopathy or other red cell disorders.
  • •6\.Women with serum transaminases, total protein and albumin \>1\.5 upper limit of normal
  • •7\.Women with serum creatinine \>1\.5 mg/dl
  • •8\.Women with known Intolerance to iron derivatives
  • •9\.Women with history of alcohol or drug abuse, bleeding disorder
  • •10\.Women having any severe active infectious disease requiring hospitalisation.

Outcomes

Primary Outcomes

Not specified

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