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.
Amendment record
Amended once since 2026-08-20. Every amendment is listed below.
Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.
2026-08-22
Amendment Study Identification, Study Status, Sponsor/Collaborators, Study Description, Arms and Interventions, Outcome Measures, IPDSharing v1
2026-08-20
Original filing