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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Eladi churna, Reference: Yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kamdudha rasa pratham, Reference: Rasyogsagar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 750(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
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Brief Summary
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The study titled Evaluation of Comparative Efficacy of Kamdudha Rasa Pratham versus Eladi Churna in the Management of Urdhwag Amlapitta (GERD) – A Randomized Controlled Trial focuses on exploring safer and cost-effective alternatives for gastroesophageal reflux disease (GERD), which in Ayurveda is correlated with Urdhwag Amlapitta. Introduction
According to Acharya Madhavkar, Amlapitta arises due to the intake of incompatible, spoiled, or excessively sour foods that aggravate pitta. Classical descriptions highlight symptoms such as indigestion, nausea, sour or bitter eructations, heaviness, and burning sensations in the chest and throat. Madhavkar classified it into Urdhwag and Adhog Amlapitta. Urdhwag Amlapitta corresponds closely with GERD, which presents with symptoms like heartburn, regurgitation, chest pain, cough, and hoarseness. Modern risk factors include age, BMI, diet, alcohol, tobacco, and lifestyle. The pooled prevalence of GERD in India is about 15.6 percent. Need of the Study
GERD cases are increasing due to lifestyle changes, stress, and irregular food habits. Current allopathic treatment mainly relies on proton pump inhibitors (PPIs), which are associated with long-term side effects including kidney disease, osteoporosis, and impaired nutrient absorption. Many patients also suffer from drug-induced gastritis or peptic ulcers due to NSAID use. Hence, there is a demand for effective, safe, and affordable Ayurvedic alternatives. Kamdudha Rasa Pratham, a simple two-ingredient formulation of Amalaki and Swarna Gairika, is cost-effective and indicated for Urdhwag Amlapitta. Eladi Churna, on the other hand, is also known for its efficacy but is a multi-ingredient formulation. Literature Review and Research Gap
Ayurvedic texts such as Kashyap Samhita, Madhavkar Samhita, and Sushrut Samhita provide detailed descriptions of Amlapitta. Previous studies have explored formulations like Eladi Churna, Katuki Churna, and Baladi Manduram in GERD, but none have compared Kamdudha Rasa Pratham with Eladi Churna. Thus, there is a significant gap in research on Kamdudha Rasa Pratham, especially in controlled clinical trials. Aim and Objectives
The study aims to evaluate and compare the efficacy of Kamdudha Rasa Pratham and Eladi Churna in Urdhwag Amlapitta. The primary objectives are to assess the efficacy of both interventions separately and to compare their therapeutic effects. Methodology
The study will be a randomized, open-label, double-arm clinical trial with 160 patients, 80 in each group. Patients aged 18 to 60 years with signs and symptoms of Urdhwag Amlapitta will be included. Group A will receive Kamdudha Rasa Pratham (3000 mg twice daily), and Group B will receive Eladi Churna (750 mg twice daily). The duration of treatment will be followed by regular assessments on the 7th and 14th day. Assessment Criteria
Subjective assessment will be done using the Urdhwag Amlapitta scale, which evaluates symptoms such as sour belching, burning sensation, loss of appetite, nausea, heaviness, and fatigue. Objective assessment will be carried out using the GERD scale, which measures heartburn, regurgitation, bloating, chest discomfort, and swallowing difficulty. Scores will determine the severity and response to treatment. Expected Outcomes and Scope
It is expected that Kamdudha Rasa Pratham will prove equally effective or superior to Eladi Churna in reducing GERD symptoms. Being simpler, cheaper, and easy to prepare, Kamdudha Rasa Pratham could be widely adopted in Ayurvedic clinical practice. This study has the potential to promote cost-effective herbal drug development, offer safe alternatives to conventional therapies, and reduce reliance on long-term PPIs. It may also encourage multicentric trials for more robust validation. Ethical Consideration
The trial will begin after institutional ethical approval and registration with the Clinical Trial Registry of India (CTRI). Conclusion
This study addresses a major gap in Ayurvedic clinical research by comparing Kamdudha Rasa Pratham with Eladi Churna for Urdhwag Amlapitta. If proven effective, it can serve as a safe, natural, and affordable therapeutic option for GERD, benefiting a large patient population and reducing dependency on modern medicines with known side effects.
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