Herbal remedy vs. standard drug: a new hope for thalassemia iron overload?

NCT ID NCT07782931

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Recruiting now
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Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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First seen Aug 24, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This trial compares an experimental herbal formulation called Irochel against the standard medication deferoxamine in managing iron overload caused by repeated blood transfusions in thalassemia patients. The study involves 132 children and adolescents aged 10 to 16 with transfusion-dependent thalassemia and high iron levels. Participants receive either Irochel tablets twice daily or deferoxamine infusions for three months, with the main goal of seeing whether Irochel can reduce serum ferritin levels as effectively as the standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Irochel, a polyherbal formulation containing extracts of six medicinal herbs, tested against deferoxamine, a standard iron-chelating drug.
What this could lead to
If Irochel works, it could offer a more accessible, oral option to manage iron overload in thalassemia patients, potentially improving quality of life.
What could go wrong
This is a single-center trial with a modest sample size, and the herbal formulation may not prove as effective or safe as the established drug deferoxamine. Results may not generalize widely.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

132 people

The number who actually took part.

Started

Feb 2019

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 20 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Chronic disorders such as hepatosplenomegaly, diabetes mellitus, and bone pain are included. Exclusion Criteria: 1. Serious cardiac patients. 2. Patients having a history of serious transfusion reactions. 3. Patients having neurological disorders. 4. Patients having a history of bad compliance.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Shifa ul Mulk Memorial Hospital

    Karachi, Sindh, 74600, Pakistan

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