A CLINICAL AND IN-SILICO ANALYSIS OF THE ADD-ON EFFECT OF DRAKSHA DADIMADI AVALEHA AND GANDHAKADI YOGA TABLETS ON THE FREQUENCY OF BLOOD TRANSFUSIONS IN THALASSEMIA MAJOR

A RANDOMIZED CONTROLLED CLINICAL AND IN SILICO ANALYSIS OF THE ADD-ON EFFECT OF DRAKSHA DADIMADI AVALEHA AND GANDHAKADI YOGA TABLETS ON THE FREQUENCY OF BLOOD TRANSFUSIONS IN THALASSEMIA MAJOR - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104651

Enrollment

Registered

2026-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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: Hb electrophoresis diagnosed cases of Thalassemia major. Age groups of 3 to 16 years of either sex. Patients on a regular blood transfusion regimen to maintain a pre-transfusion hemoglobin level between 9 and 10 g per dL. Patients having history of receiving at least 8 or more blood transfusions per year. Parents or guardian willing to give consent to participate in the study.

Exclusion criteria

Exclusion criteria: Cases having HIV, HBV infection, Hepatic failure, DM, TB, malarial infection, active liver disease etc. Other haemoglobinopathies like sickle cell anemia, hereditary spherocytosis etc. Patients having cardiac and kidney complications. Patients undergone Splenectomy and allogeneic bone marrow transplantation. Known allergy to any content of Draksha dadimadi Avaleha and Gandhakadi Yoga tablets.

Design outcomes

Primary

Measure	Time frame
Reduction in blood transfusion frequency (days) and amount of blood transfused (per session).Timepoint: 0 day,15th day,30th day,45th day,60th day,75th day,90th day and three month follow up	—

Secondary

Measure	Time frame
Improvement in Pandu Lakshana using predefined scoring scaleTimepoint: Baseline, 4 weeks, 8 weeks, 12 weeks, and follow-up at 16 weeks.;Improvement in hematocrit value and reduction in serum ferritin levels.Timepoint: Baseline and 12 weeks.;Improvement in quality of life assessed using the TranQol scale.Timepoint: Baseline and 12 weeks.;Quality of Life and KAP (Knowledge, Attitude, Practices) assessment among patients and caregivers.Timepoint: Single time point, at baseline.;Incidence, nature, severity, and causality of adverse events or adverse drug reactions.Timepoint: Throughout the entire treatment and follow-up period (0 16 weeks).	—

Measure

Time frame

Improvement in Pandu Lakshana using predefined scoring scaleTimepoint: Baseline, 4 weeks, 8 weeks, 12 weeks, and follow-up at 16 weeks.;Improvement in hematocrit value and reduction in serum ferritin levels.Timepoint: Baseline and 12 weeks.;Improvement in quality of life assessed using the TranQol scale.Timepoint: Baseline and 12 weeks.;Quality of Life and KAP (Knowledge, Attitude, Practices) assessment among patients and caregivers.Timepoint: Single time point, at baseline.;Incidence, nature, severity, and causality of adverse events or adverse drug reactions.Timepoint: Throughout the entire treatment and follow-up period (0 16 weeks).

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Countries

India

Contacts

Public ContactBhavana Nandakumar

All India Institute of Ayurveda

srajagopala@gmail.com7600902564

Outcome results