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

Recruiting

• Conditions: Iron deficiency,

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

Brief Summary

A Multicentric, Randomized, Double Arm-Parallel, Open-label, Interventional for established Mild Hormonal imbalance related iron deficiency, after administration of IP and Comparator. A total of 50 subjects aged between 18-50 years with Mild-moderate iron deficient anemia due to Mild Hormonal imbalance participated in this study.

Subjects with Mild-moderate iron deficient anemia due to Mild hormonal imbalance is allocated and provided to receive Tri-Fer fixed Dose capsules Bid for 6 months and take 1 capsule twice daily for period of 180 Days but assessment is conducted on 3 months ( 90 days ) on 3 visits during treatment duration.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-10
• Study Start: 2022-09-19

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 50

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 women’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

• Subjects below 18 years and above 60 years of age are excluded from the study.
• Patients with anemia caused by conditions other than iron deficiency.
• Patients with abnormal laboratory test values at screening.
• Patients with liver, kidney or circulatory system disease.
• Patients with a history or present illness that is a malignant tumor or autoimmune disease.
• Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening.
• Patients who underwent oral administration of an iron preparation (including an over-the counter drug or supplement) within 4 weeks before the screening.
• Severe anemia or Hormonal imbalance.
• Patients who are undergoing or undergone Hormonal therapy in last one year.
• PregnancyShift T R A N S F E R I N G V A L U E Page 24 11.
• Subjects with gastro or duodenal ulcers and are also afflicted with dysphagia & odynophagia are excluded from the study.
• 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	3month, 6 Month
months of Therapy of Tri-Fer Against the iron sulphate	3month, 6 Month

Secondary Outcome Measures

Name	Time	Method
To assess the hormonal imbalance improvement in the treatment period.	• To assess the hormonal imbalance under observation by hormonal questionnaire.

Trial Locations

Locations (1)

Rajalakshmi Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Rajalakshmi Hospital

🇮🇳Bangalore, KARNATAKA, India

DrGiri raja KV

Principal investigator

080-23254855

drgirirajkv@gmail.com