Tri-Fer and comparator, for 3-months of treatment for iron deficiency

Not Applicable

• Conditions: Health Condition 1: E611- Iron deficiency

• Registration Number: CTRI/2022/09/045556
• Lead Sponsor: Stockshift India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects who meet the following criteria shall be considered eligible to participate in the

study:

1.Subjects of age group between 18-50 years of womenââ?¬•s are included in the study.

2.Female population.

3.A diagnostic of mild-moderate iron deficient anemia due to Mild Hormonal imbalance.

4.Already established Mild Hormonal imbalance (Tri-Fer as therapy).

5.Subjects who are willing to give informed consent without any hindrance are included in

the study.

Exclusion Criteria

1. Subjects below 18 years and above 60 years of age are excluded from the study.

2. Patients with anemia caused by conditions other than iron deficiency.

3. Patients with abnormal laboratory test values at screening.

4. Patients with liver, kidney or circulatory system disease.

5. Patients with a history or present illness that is a malignant tumor or autoimmune

disease.

6. Patients who underwent intravenous administration of an iron preparation,

administration of an erythropoiesis stimulation agent or blood transfusion within 8

weeks before the screening.

7. Patients who underwent oral administration of an iron preparation (including an over-the

counter drug or supplement) within 4 weeks before the screening.

8. Severe anemia or Hormonal imbalance.

9. Patients who are undergoing or undergone Hormonal therapy in last one year.

10. PregnancyShift

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11. Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia &

odynophagia are excluded from the study.

12. Subjects with persistent GI bleeding and frequent vomiting are excluded from the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be hemoglobin-levels improvements, measured before and after 3 <br/ ><br>months of Therapy of Tri-Fer Against the iron sulphateTimepoint: 3month, 6 Month

Secondary Outcome Measures

Name	Time	Method
To assess the hormonal imbalance improvement in the treatment period. <br/ ><br>� To assess the hormonal imbalance under observation by hormonal questionnaire. <br/ ><br>� To assess Global overall symptom scale. <br/ ><br>� To assess Adverse eventsTimepoint: 3month, 6month