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

NCT07782931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-08-25

No results posted yet for this study

Summary

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.

Conditions

  • Iron Overload Due to Repeated Red Blood Cell Transfusions
  • Thalassemia Majors (Beta-Thalassemia Major)

Interventions

DRUG

Irochel

Irochel is a polyherbal formulation administered 500 mg twice daily for three months orally.

DRUG

Deferoxamine

DFO administered to Arm 2, the control group. Administered 8- to 12-hour nightly infusion, 5-7 nights a week. The average dosage is 20-40 mg per kg body weight for children and 30-50 mg per kg body weight for patients.

Sponsors & Collaborators

  • Shifa Ul Mulk Memorial Hospital

    collaborator OTHER

  • Hamdard University

    lead OTHER

Principal Investigators

  • syma ghayas · Hamdard University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2020-01-30
Completion
2022-12-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07782931 on ClinicalTrials.gov