Iron Overload Due to Repeated Red Blood Cell TransfusionsPhase 3NCT07782931
Evaluate the Efficacy and Safety of Irochel for the Management of Iron Overload in Thalassemia Patients in Comparison With Deferoxamine
A Phase 3 study testing Irochel and Deferoxamine in people with Iron Overload Due to Repeated Red Blood Cell Transfusions and Thalassemia Majors (Beta-Thalassemia Major), run by Hamdard University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Overload Due to Repeated Red Blood Cell Transfusions, Thalassemia Majors (Beta-Thalassemia Major)
- What is being tested?
- Irochel and Deferoxamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2019to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The research was conducted in individuals suffering from transfusion-dependent thalassemia (TDT) and having iron overload (IOL) with the serum ferritin (SF) value greater than 1000 ng/ml of blood.
- Chronic disorders such as hepatosplenomegaly, diabetes mellitus, and bone pain are included.
Who cannot join
- Serious cardiac patients.
- Patients having a history of serious transfusion reactions.
- Patients having neurological disorders.
- Patients having a history of bad compliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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.
Read the detailed description
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.
Significant improvements were observed in several hematological parameters following Irochel treatment. The RBC count showed a highly significant within-group improvement (p=0.000), while the corresponding change in the DFO group was insignificant (p=0.321). Hb also showed a highly significant improvement in the Irochel group (p=0.000), whereas the DFO group showed an insignificant change (p=0.121). The WBC count showed a significant improvement in the Irochel group (p=0.031), while the control group showed no significant change (p=0.270). Platelet count also improved significantly in the Irochel group (p=0.001), compared with an insignificant change in the control group (p=0.849). ESR showed no significant change in the Irochel group (p=0.125), whereas a significant change was observed in the control group (p=0.002).
The iron profile demonstrated significant changes following Irochel treatment. Serum iron showed significant improvement (p=0.030), while serum ferritin showed a highly significant change (p=0.000). In the DFO group, serum ferritin also showed a statistically significant within-group change (p=0.006). TIBC showed a significant change in the Irochel group (p=0.038), whereas the control group showed no significant change (p=0.635).
Liver-function parameters, including total bilirubin, SGPT, GGT, and ALP, showed significant improvement following Irochel treatment. Lipid-profile analysis demonstrated a significant reduction in LDL (p=0.000). In contrast, the control group showed significant changes in total cholesterol (p=0.003), LDL (p=0.000), and triglycerides (p=0.000).
Urinalysis showed improvement in several urinary parameters in the Irochel group, including RBCs, pus cells, crystals, and bacteria. Pearson correlation and linear regression analysis demonstrated a positive relationship between dominant body temperament and serum ferritin levels before and after treatment.
A clinically important improvement was observed in transfusion dependency following Irochel treatment, with increased intervals between transfusions and reduced transfusion requirements. In contrast, transfusion dependency remained persistent in the DFO group.
Irochel demonstrated good compliance and acceptability, with no reported adverse effects in the test group. In contrast, adverse effects were reported among DFO-treated subjects, including gastrointestinal and hepatobiliary complaints, bone pain, skin itching, swelling, and injection-site reactions. The Irochel group also did not require supportive medications, whereas DFO-treated subjects required various supportive therapies.
Overall clinical assessment demonstrated marked, good, and slight improvement among Irochel-treated subjects, whereas the majority of subjects in the control group showed no improvement. The estimated annual treatment cost of Irochel was substantially lower than that of DFO/Desferal therapy in Pakistan.
Overall, the findings indicate that Irochel demonstrated promising safety, acceptability, compliance, hematological and iron-profile benefits, improvement in liver and lipid parameters, reduced transfusion dependency, and potential cost-effectiveness compared with DFO. The study supports further well-designed and adequately powered clinical trials to confirm the efficacy and safety of Irochel for the management of transfusion-related iron overload in TDT patients.
- Conditions
- Iron Overload Due to Repeated Red Blood Cell Transfusions, Thalassemia Majors (Beta-Thalassemia Major)
- Being tested
- Irochel, Deferoxamine
- Keywords
- Thalassemia major, Iron overload, Irochel
- Medical subject headings
- beta-Thalassemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrochelDrug
Also called IRC
Irochel is a polyherbal formulation administered 500 mg twice daily for three months orally.
DeferoxamineDrug
Also called DFO
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.
| Study group | Role | What they receive |
|---|---|---|
| Irochel | Experimental | Irochel; Test Drug Receives: Drug: Irochel |
| Deferoxamine | Active comparator | Active Comparator: Deferoxamine (DFO); Control Drug Receives: Drug: Deferoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Ferritin Concentration
Change in serum ferritin concentration (ng/mL) from baseline to the end of the treatment period, comparing Irochel with deferoxamine.
Measured: From Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start11 Feb 2019
- Primary completion30 Jan 2020
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Overload Due to Repeated Red Blood Cell TransfusionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Collaborators
- Shifa Ul Mulk Memorial Hospital
- Responsible party
- Principal investigator, Tabiba Syma Ghayas, Hamdard University
- Investigators
- syma ghayas, Principal investigator, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782931
- Sponsor's protocol ID
- IROCHEL 2014
- Other IDs
- SYMA GHAYAS
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC8829781/
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07782931
- Acronym / sponsor ID
- IROCHEL 2014
- Conditions
- Iron Overload Due to Repeated Red Blood Cell Transfusions, Thalassemia Majors (Beta-Thalassemia Major)
- Keywords
- Thalassemia major, Iron overload, Irochel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Collaborators
- Shifa Ul Mulk Memorial Hospital
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Significant improvements were observed in several hematological parameters following Irochel treatment. The RBC count showed a highly significant within-group improvement (p=0.000), while the corresponding change in the DFO group was insignificant (p=0.321). Hb also showed a highly significant improvement in the Irochel group (p=0.000), whereas the DFO group showed an insignificant change (p=0.121). The WBC count showed a significant improvement in the Irochel group (p=0.031), while the control group showed no significant change (p=0.270). Platelet count also improved significantly in the Irochel group (p=0.001), compared with an insignificant change in the control group (p=0.849). ESR showed no significant change in the Irochel group (p=0.125), whereas a significant change was observed in the control group (p=0.002).
The iron profile demonstrated significant changes following Irochel treatment. Serum iron showed significant improvement (p=0.030), while serum ferritin showed a highly significant change (p=0.000). In the DFO group, serum ferritin also showed a statistically significant within-group change (p=0.006). TIBC showed a significant change in the Irochel group (p=0.038), whereas the control group showed no significant change (p=0.635).
Liver-function parameters, including total bilirubin, SGPT, GGT, and ALP, showed significant improvement following Irochel treatment. Lipid-profile analysis demonstrated a significant reduction in LDL (p=0.000). In contrast, the control group showed significant changes in total cholesterol (p=0.003), LDL (p=0.000), and triglycerides (p=0.000).
Urinalysis showed improvement in several urinary parameters in the Irochel group, including RBCs, pus cells, crystals, and bacteria. Pearson correlation and linear regression analysis demonstrated a positive relationship between dominant body temperament and serum ferritin levels before and after treatment.
A clinically important improvement was observed in transfusion dependency following Irochel treatment, with increased intervals between transfusions and reduced transfusion requirements. In contrast, transfusion dependency remained persistent in the DFO group.
Irochel demonstrated good compliance and acceptability, with no reported adverse effects in the test group. In contrast, adverse effects were reported among DFO-treated subjects, including gastrointestinal and hepatobiliary complaints, bone pain, skin itching, swelling, and injection-site reactions. The Irochel group also did not require supportive medications, whereas DFO-treated subjects required various supportive therapies.
Overall clinical assessment demonstrated marked, good, and slight improvement among Irochel-treated subjects, whereas the majority of subjects in the control group showed no improvement. The estimated annual treatment cost of Irochel was substantially lower than that of DFO/Desferal therapy in Pakistan.
Overall, the findings indicate that Irochel demonstrated promising safety, acceptability, compliance, hematological and iron-profile benefits, improvement in liver and lipid parameters, reduced transfusion dependency, and potential cost-effectiveness compared with DFO. The study supports further well-designed and adequately powered clinical trials to confirm the efficacy and safety of Irochel for the management of transfusion-related iron overload in TDT patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Irochel | Experimental | Drug: IrochelIrochel; Test Drug |
| Deferoxamine | Active comparator | Drug: DeferoxamineActive Comparator: Deferoxamine (DFO); Control Drug |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The research was conducted in individuals suffering from transfusion-dependent thalassemia (TDT) and having iron overload (IOL) with the serum ferritin (SF) value greater than 1000 ng/ml of blood.
- Chronic disorders such as hepatosplenomegaly, diabetes mellitus, and bone pain are included.
Key exclusion criteria (4 listed)
- Serious cardiac patients.
- Patients having a history of serious transfusion reactions.
- Patients having neurological disorders.
- Patients having a history of bad compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrochelAlso: IRCIrochel is a polyherbal formulation administered 500 mg twice daily for three months orally. | Drug | Irochel |
| DeferoxamineAlso: DFODFO 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. | Drug | Deferoxamine |
Primary outcome
Change in Serum Ferritin Concentration
Time frame: From Baseline to 3 Months
Change in serum ferritin concentration (ng/mL) from baseline to the end of the treatment period, comparing Irochel with deferoxamine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Backgroundhttps://pmc.ncbi.nlm.nih.gov/articles/PMC8829781/
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
syma ghayas principal investigator
Hamdard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irochel and Deferoxamine in people with Iron Overload Due to Repeated Red Blood Cell Transfusions and Thalassemia Majors (Beta-Thalassemia Major), run by Hamdard University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Ferritin Concentration (time frame: From Baseline to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.