Ayurveda Add-on therapy in Thalassemia patients

Effectiveness of Add-on Bhumyamalaki to Standard Chelation therapy in managing Iron overload in transfusion dependent Thalassemia Patients: An Open Randomized Controlled Pilot Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086820

Enrollment

Registered

2025-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D561- Beta thalassemia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed subjects of Thalassemia on regular blood transfusions Subjects on stabilized dose of chelators for minimum of 3 months Subjects having iron overload with Serum ferritin levels more than 1200 ng/mL Participants ready to sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects on hydroxyurea 2. Participation in another trial 3. Children below 18 years, pregnancy and lactation 4. Severe liver or renal impairment (3 times more than ALP, AST and eGFR less than 60 as calculated by CKD-EPI equation) required other interventions 5. Current use of other herbal supplements 6. Subjects with established diagnosis of any cardiovascular illness or any other severe concurrent illness

Design outcomes

Primary

Measure	Time frame
Changes in Serum Ferritin levels in Bhumyamalaki group in comparison with control groupTimepoint: Baseline to 32nd, 64th and 96th day	—

Secondary

Measure	Time frame
Any changes in haematological parameters (haemoglobin levels, red blood cell indices)Timepoint: Baseline to 32nd, 64th & 96th day;Any changes in liver and renal function markersTimepoint: Baseline to 96th day	—

Countries

India

Contacts

Public ContactKavya Nagarajan

Rashtrotthana Research Centre,

dr.kavya.n@rashtrotthanahospital.com09886084305

Outcome results