A Comparative Study to Evaluate the Efficacy and Safety of Irochel (Unani Coded Formulation) for the Management of Transfusion-Induced Iron Overload in Thalassemia Patients in Comparison With Deferoxamine

This experimental, randomized, controlled clinical trial evaluated the safety and efficacy of the coded Unani polyherbal formulation Irochel (IRC) for the management of iron overload (IOL) caused by repeated blood transfusions in transfusion-dependent thalassemia (TDT) patients, in comparison with Deferoxamine (DFO). A total of 132 diagnosed TDT patients of both genders, aged 10-16 years, participated in the study. The trial was conducted from 2014 to 2020 at Hamdard Matab, Araam Bagh, Karachi, with patients referred from several thalassemia centers, including NIBD, Fatimid Foundation, Umair Sana Thalassemia Center, Kashif Iqbal Thalassemia Center, Civil Hospital, and Hussaini Blood Bank. Data were collected using Clinical Record Forms (CRFs) and analyzed using SPSS version 23. The study comprised two phases: (1) development and preclinical evaluation of Irochel and (2) clinical evaluation in human subjects.

Irochel is a 500-mg polyherbal tablet containing six medicinal plants. These herbs possess diverse phytotherapeutic and nutraceutical properties and contain bioactive compounds potentially relevant to iron chelation, antioxidant activity, and management of thalassemia-associated complications.

During formulation development, the herbs were authenticated and subjected to organoleptic and pharmacognostical evaluation. Phytochemical screening demonstrated alkaloids, amino acids, carbohydrates, proteins, flavonoids, glycosides, saponins, tannins, and resins. The formulation was evaluated for cytotoxicity, antioxidant, antimicrobial, toxicological, and pharmaceutical properties. The brine shrimp lethality assay demonstrated an LC50 of 24.327 µg/mL, while DPPH analysis showed significant free-radical scavenging activity. Moderate antimicrobial activity was observed against Staphylococcus aureus. Acute and subacute toxicity studies indicated no major behavioral, gross pathological, or histopathological toxicity, although some hematological and biochemical parameters showed significant changes warranting further evaluation.

Pharmaceutical quality-control testing confirmed satisfactory physical characteristics, including tablet weight, dimensions, hardness, friability, disintegration, granule uniformity, flow, lubrication, particle distribution, and manufacturing parameters.

In the randomized clinical trial, 66 subjects were assigned to each group. The control group received DFO subcutaneously through a portable infusion device for 8-12 hours daily at 40-60 mg/kg body weight, while the test group received Irochel 500 mg twice daily orally with lukewarm milk. Baseline demographic characteristics, vital signs, BMI, and clinical findings were assessed. Following treatment, improvements were observed in general health and several systemic complaints in the Irochel group.