Comparative Effectiveness of Akika Pishti with Jatamansyadi Kwath in the Management of Raktagata Vata (Essential Hypertension) - Study Protocol for an Open Labelled Randomized Controlled Trial

Abstract

Ayurveda has described several treatment modalities regarding the treatment of Raktagata Vata including the usage of herbo-mineral formulations, yoga and lifestyle modifications. The purpose of this study is to compare the efficacy of a mineral formulation Akika Pishti with Jatamansyadi kwath in the treatment of Raktagata Vata patients. Despite the fact that there are many formulations, no research has been done to demonstrate Akika Pishti\'s effectiveness in treating Raktagata vata. Methods and design- In a prospective, open labelled, randomized controlled trial,60 patients, between 18 and 45 years, diagnosed with Raktagata Vata, presenting with cardinal features of Raktagata Vata as presented in Ayurvedic texts, two groups will be randomly assigned. In Group one, the patients will be given Akika Pishti and in Group two, patients will be given Jatamansyadi kwatha. Guidelines regarding Pathya-apathya will be given to both the groups. The course of treatment will last for 28 days for both groups. Outcomes will be evaluated on 7th, 14th, 21st& 28th (During treatment) & 42nd day (post-treatment). Result: The primary result will be assessed by checking the grading of the cardinal symptoms of Raktagata Vata mentioned in Ayurvedic texts. Secondary outcome will check for reduction in systolic and diastolic blood pressure and improvement in quality of life of the patient. Conclusion: This trial compares the efficacy of Akika Pishti with Jatamansyadi kwath in the patients of Raktagata Vata. Akika Pishti is envisioned to improve the symptoms of Raktagata Vata, thus proving to be effective in management of patients of Raktagata Vata.

Introduction

Hypertension, known as the "Silent Killer," primarily involves essential hypertension (>95%) with significant risks of organ damage and death. It is often asymptomatic and detected only during routine checks or complications. Ayurvedic concepts correlate hypertension with conditions like Raktagata Vata, involving imbalances in doshas (Vata, Pitta) and blood (Raktadhatu), affecting heart function and circulation. Hypertension prevalence increases with age and contributes to strokes and ischemic heart disease.

Trial Design:
A prospective, randomized, open-label, parallel-group clinical trial will compare two Ayurvedic treatments (Akikapishti and Jatamansyadikwath) for essential hypertension. The study is ethically approved and registered, with a 28-day intervention and follow-up visits.

Methods:

• Interventions: Group A receives Akikapishti (250 mg + honey), Group B receives Jatamansyadikwath (a herbal decoction) twice daily.

• Eligibility: Adults 18-45 years with prehypertension or stage 1 hypertension and Ayurvedic signs of Raktagata Vata. Exclusions include severe hypertension, secondary hypertension, certain comorbidities, drug abuse, or drug hypersensitivity.

• Procedures: Informed consent, screening, medical history, and Ayurvedic examinations will be conducted. Follow-ups every 7 days during and after treatment.

• Outcomes: Primary—improvement in Ayurvedic symptoms of Raktagata Vata; Secondary—reduction in blood pressure and improved quality of life. Symptoms are graded on severity scales.

Randomization and Blinding:
Participants are randomly assigned 1:1 to treatment groups; allocation concealment maintained but no blinding.

Data Collection and Analysis:
Data on symptoms and blood pressure collected by the researcher; statistical analysis will use t-tests with significance at p ≤ 0.05.

Discussion:
The trial aims to evaluate the efficacy of two Ayurvedic treatments for hypertension, a major contributor to strokes and heart disease. Hypertension’s asymptomatic nature often delays diagnosis; common symptoms include headache, fatigue, dizziness, and palpitations.

Conclusion

The disease Hypertension is referred to as the \"Silent\" or \"Hidden Killer\" in medical terminology because of the End organ (Trimarmas) damages that have disastrous and dangerous effects on humans and ultimately result in death. Over 95% of Hypertension is categorized under essential hypertension. Hypertension may be defined clinically as the level of blood pressure at which the institution of therapy reduces blood pressure-related morbidity and mortality [1].

References

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Copyright

Copyright © 2025 Dr. Himanshu Bhusan Pradhan, Dr. Neha Lamba, Dr. Neelam Kumari. 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.