Development And Validation Of Dhuma Yantra And Its Comparative Clinical Evaluation With Navan Nasya And Dhuma Nasya With Classical Method In Ardhavabhedaka (Migraine): A Randomized Controlled Trial

Need of the Study:

Migraine, known as Ardhavabhedaka in Ayurveda, affects approximately 14.12% to 25.2% of the Indian population, yet safe and sustainable alternatives to conventional therapies remain limited. Traditional Ayurvedic instruments, such as the Dhuma Yantra, lack standardization, leading to inconsistent results due to variations in size and material. Furthermore, there is insufficient comparative evidence between Shirovirechanadi Dhumavarti and Anu Taila Nasya, despite the latter’s established efficacy in symptom alleviation ranging from 45.4% to 76%. There is a growing necessity to integrate Ayurvedic therapies such as Dhuma and Nasya with modern clinical protocols, particularly for managing Vata-Kapha conditions. Although Nasya is a relatively simple procedure, Dhumavarti protocols should be simplified further to ensure better patient compliance. Migraine continues to be a widespread condition that remains inadequately managed, and current treatments like analgesics are not suitable for long-term use. A significant portion of the population continues to suffer due to the limitations of existing treatment options. Therefore, simplifying Ayurvedic smoke therapy methods can potentially improve patient experience and outcomes.

Rationality of the Study:

A comparative evaluation is essential, as existing research highlights the multiple benefits of Dhuma Nasya therapy, such as relief from headaches, migraines, and nasal congestion, while also balancing Vata and Kapha doshas. However, the absence of standardized devices and the lack of systematic comparison with well-established therapies like Navan Nasya have created a gap in evidence-based Ayurvedic practice. This study aims to address this gap by conducting a rigorous clinical evaluation of an improved Dhuma Yantra in comparison with proven traditional methods.

Objectives:

Primary:

Development and validation of a standardized Dhuma Yantra.

Evaluation of whether Anu Taila Nasya provides superior clinical outcomes in symptom reduction, assessed using a standardized scoring system, compared to Dhuma Nasya with Shirovirechanadi Dhumavarti administered through the classical method and prototype Dhuma Yantra.

Secondary:

Assessment of the impact of headaches on daily life using the HIT-6 questionnaire.

Improvement in the Migraine Specific Quality of Life Questionnaire (MSQ) and Visual Analogue Scale (VAS).

Methodology:

Type of Study: Triple-arm interventional clinical trial. Study Design: Randomized comparative clinical trial. Study Duration: Two and a half years. Study Site: Patients attending the Panchakarma OPD and IPD at AIIA who meet the diagnostic criteria will be recruited. Sampling Procedure: Probability sampling. Randomization: Simple randomization. Blinding or Masking: Open-label study.