Comparative in vivo evaluation of Toxicity and Aphrodisiac activity in drug-induced erectile dysfunction of Sidha Shalmali Kalpa (Shalmali malabarica formulation) with its modified form – A Research Protocol

Introduction: Infertility has a prevalence of 15% in couples globally. Of this, 50 % infertility cases are due to problems in males. Sidha Shalmali Kalpa has been mentioned in Bhaishajya Ratnavali for its Aphrodisiac activity. This study aims to reduce the incidence of male infertility and improve reproductive health. Current pharmacological treatment has adverse side effects and is unsuitable for long-term use. Therefore, there is a need for safer alternatives. SSK (Shalmali malabarica formulation) is described for improving male reproductive functions; its safety and efficacy are not supported by scientific evidence. Therefore, the present study demonstrates the Vaijikarana activity of the drugs using modern scientific parameters. It helps to integrate Ayurvedic formulations into evidence-based reproductive healthcare. Methods: This experimental study will be conducted at a certified animal house.  All raw ingredients will collected from authentic sources. Then, they will verify for authenticity. SSK and its modified dosage form will prepare, standardized, and analyzed as per the Ayurvedic Pharmacopoeia of India (API).  An Acute toxicity study will conducted in male rats (6 rats per group - 2 groups) in accordance with OECD guidelines. In the Efficacy study, the aphrodisiac activity will examine in both normal and drug (Paroxetine) - induced erectile dysfunction animal models (6 rats per group: 6 groups of male rats and 1group of female rats). General clinical observations, such as behavioural parameters (mount latency/frequency, intromission latency/frequency), along with biochemical marker assessments (Serum testosterone, ALP levels), will conducted. Histopathological studies of vital organs will also carry out to assess safety. Conclusion: This study will likely to generate scientific evidence regarding the safety and aphrodisiac activity of classical SSK and its modified form. The modified form of SSK is likely to exhibit increased therapeutic efficacy, possibly due to improved bioavailability and its constituent photochemical.