The safety and efficacy of Ferric Pyrophosphate MR Tablets in female patients with iron deficiency anemia.
Recruiting
- Conditions
- Other iron deficiency anemias. Ayurveda Condition: others,
- Registration Number
- CTRI/2021/06/034391
- Lead Sponsor
- NutraXceed Lifesciences Pvt Ltd
- Brief Summary
This will be a controlled open label parallel- group study. It is projected that the study will randomize 15 women (5 subjects in each treatment arm) with iron deficiency anemia (Hb 8-11.9 gm/dl + serum transferrin saturation <20%,serum and serum ferritin ≤ 15ng/ml). The rationale for conducting this study is to compare the safety and effectiveness of ferric pyrophosphate MR tablets in increasing Hb levels in iron deficiency anemia patients in comparison to Orofer-XT tablets
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 15
Inclusion Criteria
- 1.Signed and dated written informed consent is obtained prior to participation.
- 2.Female outpatients between 18 to 55 years of age and using effective method of contraception if sexually active.
- 3.Non-use of any iron supplement for 3 months prior to enrolment to the study.
- 4.Presence of iron deficiency anaemia: low haemoglobin (Hb 8-11.9 gm/dl) + low serum ferritin (≤ 15 mg/ml) and serum transferrin saturation saturation <20%.
- 5.Able to comply with the requirements of the protocol.
Exclusion Criteria
- A subject will not be eligible for inclusion in this study if ANY of the following criteria apply: • Pregnancy (confirmed by urine dipstick method) • Desire to conceive within the next 3 months including patients who are receiving treatment to facilitate conception.
- • Lactating women.
- • Medical history of current haematological disorders other than iron deficiency anemia, thyroid dysfunction, chronic renal disease or any other condition which may interfere with the study in the opinion of a Principal Investigator should be excluded.
- • Inability to withhold prohibited medication.
- • Obvious internal or external bleeding as documented by medical history and/or examination if considered clinically significant in the opinion of the investigator.
- • Serious, uncontrolled disease (other than thyroid dysfunction and chronic renal disease) including serious psychological disorders likely to interfere with the study and/or likely to cause death within the study period.
- • Participation in another clinical trial in the last 8 weeks before entry to Visit 0.
- • Evidence of alcohol or drug abuse, that may, in the opinion of the investigator interfere with study compliance or prevent understanding of the objectives, investigational procedures or possible consequences of the study.
- • Known or suspected hypersensitivity to iron or any of the components of Ferric Pyrophosphate MR Tablets or Orofer XT tablets.
- • Patients with any other reason which may interfere with the study in the opinion of a Principal Investigator should be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean haemoglobin rise every 4 weeks up to 12 weeks in each Ferric Pyrophosphate MR tablets group (30 mg/day and 60mg/day tablets). Week 4, Week 8 ,Week 12
- Secondary Outcome Measures
Name Time Method Mean haemoglobin rise every 4 weeks up to 12 weeks in each Ferric Pyrophosphate MR tablets group (30 mg/day and 60mg/day tablets). week 12
Trial Locations
- Locations (1)
Jehangir Clinical Development Centre.Pvt.Ltd
🇮🇳Pune, MAHARASHTRA, India
Jehangir Clinical Development Centre.Pvt.Ltd🇮🇳Pune, MAHARASHTRA, IndiaDrAlmas PathanPrincipal investigator9763002830almas.jikare@rediffmail.com