Evaluate the Efficacy and Safety of Irochel for the Management of Iron Overload in Thalassemia Patients in Comparison With Deferoxamine

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Primary endpoint revised
    • Study description shortened, about 2,253 words
    • Study title shortened, about 17 words
    v2
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This research study was an experimental, randomized, controlled clinical trial to evaluate the safety and efficacy of coded Unani formulation Irochel for the management of IOL due to repetitive blood transfusion in comparison with DFO in already diagnosed 132 transfusion-dependent thalassemia patients of both genders of 10 years to 16 years of age. The study was conducted at Hamdard Matab, Araam Bagh, where patients came from multiple thalassemia centers such as the Hussaini Blood Bank, National Institute of Blood Diseases (NIBD), Fatimid Foundation, Umair Sana Thalassemia Center, Kashif Iqbal Thalassemia Center, and Civil Hospital. The data was collected through the Clinical Record Form (CRF) and then analyzed by SPSS version 23. The study was conducted during the years 2014-2020. The study comprises two phases: 1) Development of Irochel and 2) Clinical Trials. The "Irochel" is a round, disk-shaped, black-colored, bitter, polyherbal formulation of 500 mg (tablet) with a characteristic odor. It consists of different ratios of extracts (hydroethanolic) of six medicinal herbs. The combined effect of these novel herbs was found to be potent in iron chelation and helps to improve the quality of life of thalassemia patients due to their high nutritional values and ethnopharmacological activities and their broad spectrum of therapeutic potential.
Trial Details
NCT Number NCT07782931
Lead Sponsor Hamdard University
Collaborators: Shifa Ul Mulk Memorial Hospital
Conditions
(from sponsor)		 Iron Overload Due to Repeated Red Blood Cell Transfusions, Thalassemia Majors (Beta-Thalassemia Major)
Related terms beta-Thalassemia, Iron Overload
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov