Protocol for an Open Labelled Randomised Comparative Clinical Study to Evaluate Efficacy of Gudanagaradi Gutika and Phalatrikadi Kwatha in Management of Pandu Roga (Iron Deficiency Anaemia)

Abstract

In Ayurveda, Pandu Roga is one of the major disease described in classical Ayurvedictexts, presents with symptoms similar to Iron Deficiency Anaemia (IDA) such as pallor, fatigue, anorexia. In India Anaemia affects estimated 50% of the population. Conventional iron supplements, although effective, are often accompanied by gastrointestinal and other adverse effects. Traditional formulations Gudanagaradi Gutika and Phalatrikadi Kwatha offer potential safer alternatives based on their hematopoietic and digestive stimulant properties. This study aims to compare these two Ayurvedic interventions for managing Pandu Roga . Objective: To evaluate and compare the clinical efficacy and safety of Gudanagaradi Gutika and Phalatrikadi Kwatha in the management of Pandu Roga (Iron Deficiency Anaemia). Methods: A single-centered, open-labelled, parallel comparative clinical trial will be conducted on 60 patients (aged 25–45 years) diagnosed with Pandu Roga.Participants will be randomized into two groups (n = 30 each).Group-A(Intervention),Gudanagaradi Gutika (500?mg twice daily) and Group-B (Comparator),Phalatrikadi Kwatha (50?ml twice daily).The treatment will continue for 28 days. Outcome assessments include subjective parameters (pallor, anorexia, etc.) and objective parameters (Hemoglobin levels, Serum Ferritin etc). Follow-up evaluations on days 7th, 14th, 21st, 28th during treatment and days 42nd and 56th post-treatment. Statistical significance is set at p < 0.05. Expected Results: Both formulations will anticipated to improve clinical symptoms and hematological parameters; however, Gudanagaradi Gutika is hypothesized to yield a superior efficacy because of its hematopoietic and digestive stimulant components. Conclusion: This study may validate evidence-based Ayurvedic alternative to conventional IDA therapies, supporting the integration of traditional formulations into mainstream management protocols.

Introduction

The text discusses Pandu Roga, an Ayurvedic condition analogous to Iron Deficiency Anemia (IDA), describing its causes and symptoms according to classical texts like Charaka and Sushruta Samhita. It explains how imbalances in the body’s doshas and dhatus, particularly Pitta and Rasa, lead to anemia-like symptoms such as pallor and fatigue. IDA is prevalent globally and conventional treatments often have side effects.

This clinical trial compares two Ayurvedic treatments—Gudanagaradi Gutika, a formulation containing hematopoietic and digestive herbs, and Phalatrikadi Kwatha, known for its Pitta-pacifying and digestive properties—in patients aged 25-45 with mild to moderate IDA. Sixty patients will be randomly assigned to either treatment group for 28 days, followed by assessments up to 56 days.

The study uses subjective Ayurvedic symptom scales (pallor, weakness, anorexia, etc.) and objective lab parameters (hemoglobin, serum ferritin) to evaluate efficacy. Ethical approval and trial registration are obtained. Data will be statistically analyzed to determine comparative outcomes.

Conclusion

This study protocol details an open labelled, parallel comparative clinical trial aimed at evaluating the efficacy and safety of Gudanagaradi Gutikaversus Phalatrikadi Kwatha in patients with Pandu Roga(IDA). Successful results could pave the way for evidence based integration of Ayurvedic treatment modalities into modern healthcare practice.

References

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Copyright

Copyright © 2025 Dr. Pooja, Dr. Neelam Kumari , Dr. Neha Lamba . This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.