A comparative clinical trial to evaluate the efficacy of nimbapatradi dhara against saribaneeli dhara in lutha visha

This clinical trial is designed as a randomized, single-blind, comparative study to investigate the therapeutic efficacy and safety of Nimbapathradi Dhara in the management of Lutha Visa, commonly known as spider envenomation. In the field of Agadatantra, spider bites are recognized as a significant cause of localized tissue reactions, including pain, swelling, and necrosis, yet specific antivenom treatments remain unavailable in many clinical settings. The study aims to evaluate a classical Ayurvedic formulation, Nimbapathradi Dhara—comprising Azadirachta indica, Pongamia pinnata, and Curcuma longa against the established standard of Saribaneeli Dhara.

The trial will involve 56 participants, aged between 18 and 60 years, who present with diagnostic signs of spider poisoning such as discoloration, vesicles, itching, and burning sensations within 72 hours of the bite. These participants will be randomly allocated into two equal groups of 28 individuals each. Both groups will receive a standardized internal administration of Lodhrasevyadi Kashaya, an herbal decoction, twice daily. The primary distinction between the groups lies in the external intervention: the trial group will receive Nimbapathradi Dhara, while the control group will receive Saribaneeli Dhara. The Dhara procedure involves pouring the lukewarm medicated decoction over the affected area for 30 minutes twice daily over a 7-day treatment period.

The primary objective is to compare the reduction in clinical symptoms between the two formulations, while secondary objectives include assessing the safety profile and the time required for complete symptom resolution. Clinical assessments will be conducted on the 1st, 3rd, 5th, and 7th days of treatment, with a final follow-up on the 8th day. Symptoms such as pain, itching, and burning sensations will be quantified using the Visual Analog Scale (VAS), while erythema, swelling, and exudation will be measured using the Total Severity Score (TSS).

The data collected will undergo statistical analysis using SPSS. Continuous variables will be analyzed using the independent t-test or the Mann-Whitney U test depending on the distribution of the data, with a significance level set at p less than 0.05. By scientifically documenting the efficacy of Nimbapathradi Dhara, this research seeks to validate an accessible and cost-effective Ayurvedic treatment protocol that could be integrated into public health management for spider bites, particularly in endemic regions like Northern Kerala. The study will be conducted at the Pappinissery Visha Chikitsa Kendram under the MVR Ayurveda Medical College, ensuring adherence to ethical guidelines and institutional oversight.