DOI: 10.4103/jras.jras_27_26 ISSN: 2456-5601

Efficacy of Kaishore Guggulu and Asanadi Kwatha in newly diagnosed mild-to-moderate type 2 diabetes mellitus: Protocol for an open-label, randomized, parallel-group comparative exploratory study

Ayush Gupta, Amit K. Rai, Sujata Yadav
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Abstract

BACKGROUND:

Type 2 diabetes mellitus (T2DM) remains a significant global health concern. Although a wide range of pharmacological treatments are currently in use, maintaining long-term glycemic control continues to be difficult, partly due to the adverse effects and the economic burden of long-term use of medications. The proposed Ayurveda interventions are intended to correct deranged metabolism due to the antihyperglycemic, anti-inflammatory, hepatoprotective, and antioxidant properties of their ingredients.

OBJECTIVE:

To determine the efficacy and safety of Ayurvedic interventions, Asanadi Kwatha and Kaishore Guggulu , in managing newly diagnosed mild-to-moderate T2DM.

MATERIALS AND METHODS:

The present study is an open-label, randomized, parallel-group comparative clinical trial involving 60 participants. This study is being carried out in the Kayachikitsa Outpatient Department of an Ayurvedic hospital in New Delhi. Individuals aged 35–65 years diagnosed with T2DM with a fasting blood sugar of 126–179 mg/dL and glycated hemoglobin (HbA1c) of 6.5%–7.9% are eligible to participate in the study. The participants are randomly allocated into two study groups, with Group A receiving Kaishore Guggulu 1 g (two tablets of 500 mg each) twice daily after meals with lukewarm water and Group B receiving Asanadi Kwatha 40 mL twice daily before meals, for 12 weeks. The primary outcome is the change in fasting and postprandial blood sugar levels from baseline. The secondary outcomes include changes in HbA1c, clinical features of Madhumeha , and quality-of-life assessment using the 12-item short form health survey questionnaire, incidence of adverse events, and laboratory safety parameters (liver and kidney function tests).

CONCLUSION:

The present study aims to generate preliminary evidence on the comparative therapeutic efficacy and safety profile of Kaishore Guggulu and Asanadi Kwatha in managing early-stage T2DM.

CTRI REGISTRATION:

Clinical Trial Registry of India (CTRI/2025/03/082230 dated March 12, 2025).

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