Protocol for an Open Labelled Parallel Comparative Clinical Study to Evaluate the Efficacy of Karkashdaladi Kwath and Navaka Guggulu in the Management of Medodushti with Special Reference to Dyslipidemia

Abstract

Background: Dyslipidemia can be correlated with Medodushti as described in Ayurveda. It is characterized by abnormal lipid metabolism and is highly prevalent worldwide. Dyslipidemia is one of the major modifiable risk factors for diabetes mellitus, obesity, chronic heart diseases, and thyroid disorders. Although statins are the treatment of choice in modern medicine, their long-term use may be associated with several adverse effects. Therefore, there is a need to explore safe and effective Ayurvedic interventions for its management. Objective: To evaluate and compare the clinical efficacy of Karkashdaladi Kwath and Navaka Guggulu in the management of Medodushti w.s.r to Dyslipidemia. Methods: A single-centered, open-labelled, parallel comparative clinical trial will be conducted on 60 patients (aged 25–45 years) diagnosed with Medodushti. Participants will be randomized into two groups (n = 30 each). GroupA Karkashdaladi kwath (50ml twice daily) and Group-B), Navaka Guggulu (500 mg twice daily).The treatment will continue for 28 days. Outcome assessments include subjective parameters (dyspnoea, thirst etc.) and objective parameters (T. Cholestrol, triglyceride, LDL 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 indices and biochemical data related to Dyslipidemia in Medodushti patients. However, Karkashdaladi Kwath is hypothesized to yield a superior efficacy because of its Strotovishodhana (channel cleansing), Aamapachana (digestion of metabolic toxins) properties. Conclusion: This study may validate evidence-based Ayurvedic alternative to conventional treatment, supporting the integration of traditional formulations into mainstream management protocols.

Introduction

The text presents a clinical trial protocol comparing Karkashdaladi Kwath with Navaka Guggulu for the management of Medodushti (correlated with dyslipidemia) from an Ayurvedic perspective.

• Concept and pathogenesis: In Ayurveda, Medodushti refers to impaired metabolism and abnormal accumulation of Meda Dhatu (fat tissue), mainly due to weakened Medodhatvagni. Sedentary habits and excessive intake of heavy, oily, and sweet foods contribute to Agni impairment, Ama formation, and blockage of Srotas. This process is considered a precursor to Medoroga and is correlated in the study with modern dyslipidemia.

• Modern correlation: Dyslipidemia involves abnormal levels of total cholesterol, triglycerides, LDL-C, and HDL-C and is an important risk factor for cardiovascular disease and stroke. The study relates Ayurvedic Abaddha Medas to circulating serum lipids.

• Rationale for the study: Although statins are widely used for dyslipidemia, the text highlights their potential adverse effects and proposes the need to investigate Ayurvedic alternatives. Both Karkashdaladi Kwath and Navaka Guggulu contain drugs with Ruksha, Laghu, Tikshna, Ushna, Deepana, Pachana, and Lekhana properties, which are traditionally considered useful for improving digestion, reducing Ama, and eliminating excess Meda.

• Research gap: Previous research has examined Medoroga, but a direct comparative evaluation of Karkashdaladi Kwath versus Navaka Guggulu for Medodushti/dyslipidemia has not been adequately studied. This trial aims to address that gap.

Study Design

• Type: Single-center, open-label, randomized, parallel comparative clinical trial.
• Participants: 60 patients, divided into two groups of 30.
• Age: 25–45 years, either sex.
• Setting: Institute for Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra, Haryana.
• Treatment duration: 28 days, followed by follow-up until Day 56.
• Group A: Karkashdaladi Kwath, 50 mL twice daily.
• Group B: Navaka Guggulu, 500 mg twice daily.

Eligibility

Participants must have confirmed Medodushti/dyslipidemia according to specified NCEP-ATP III criteria, particularly borderline-high lipid levels. Patients with major conditions such as coronary artery disease, kidney disease, uncontrolled diabetes or hypertension, pregnancy/lactation, or certain medications are excluded.

The study has received institutional ethical approval and is registered with the Clinical Trials Registry–India (CTRI/2024/07/070151).

Assessment

The effectiveness of treatment will be evaluated through:

• Subjective symptoms: exertional dyspnoea, increased thirst, drowsiness, excessive sleep, snoring, fatigue/heaviness, increased appetite, excessive sweating, body odour, general debility, and reduced libido.
• Objective measures: changes in body weight, BMI, serum cholesterol, triglycerides, and LDL.
• Laboratory investigations: hematological, glucose, liver-function, kidney-function, and lipid-profile tests at specified stages of the study.

Statistical analysis will use mean ± SD, within-group and between-group comparisons, with p < 0.05 considered statistically significant.

Ayurvedic Rationale

The proposed mechanism is that both formulations may improve Agni, digest Ama, clear obstructed Srotas, and reduce excessive Meda. Karkashdaladi Kwath is characterized mainly by Katu/Tikta Rasa, Laghu-Ruksha-Tikshna Guna, and Ushna Virya. Navaka Guggulu contains ingredients such as Trikatu, Chitraka, Triphala, Vidanga, and Guggulu, which are traditionally described as having Deepana, Pachana, and Lekhana effects.

Conclusion

This study protocol details an open labelled, parallel comparative clinical trial aimed at evaluating the efficacy and safety of Karkashdaladi Kwath and Navaka Guggulu in patients with Medodushti with special reference to Dyslipidemia. Successful results could pave the way for evidence based integration of Ayurvedic treatment modalities into modern healthcare practice. 1) Funding Sources Funding: This research is supported by the financial allotment from the Institute for Ayurved Studies & Research, Faculty of Ayurved, Kurukshetra. 2) Conflict of Interest: The authors declare no conflict of interest. 3) Declaration of generative AI in scientific writing: The authors have not used any AI tools for writing this manuscript. 4) Acknowledgments: The authors acknowledge the support of the Pharmacy/Ras Shastra & Bhaishajya Kalpana Department, the Central Research Laboratory at Shri Krishna AYUSH University, and the Pathology Laboratory at the Institute for Ayurved Studies & Research.

References

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Copyright

Copyright © 2026 Dr. Charu Walia, 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.