Comparative Efficacy of Gorakhmundi Vati versus Hingwadi Vati with Adjuvant Marma Chikitsa in the Management of Vishaada (Mild Depression): A Randomised Controlled Trial Protocol

Introduction: “Depression, including mild and moderate forms, significantly affects affects the quality of life”. It is characterised by persistent “sadness, lack of interest in activities, fatigue, and cognitive impairments”. According to the World Health Organisation (WHO), depression is a leading cause of disability worldIntroduction: “Depression, including mild and moderate forms, significantly affects affects the quality of life”. It is characterised by persistent “sadness, lack of interest in activities, fatigue, and cognitive impairments”. According to the World Health Organisation (WHO), depression is a leading cause of disability worldwide, with a complex aetiology involving biological, psychological, and social factors. Despite the availability of pharmacological and psychotherapeutic interventions, the need for integrative and holistic treatment options has gained prominence due to side effects, limited efficacy, and high relapse rates associated with conventional therapies. Need of the study: The WHO identifies depression as a leading global health issue, affecting over 280 million people worldwide. Although modern treatments are effective, they are often accompanied by side effects and high relapse rates, necessitating integrative therapeutic approaches. Ayurveda offers holistic interventions rooted in ancient texts. Gorakhmundi vati, derived from Sphaeranthus indicus, is described in Bhavaprakasha Nighantu as possessing Medhya (brain tonic) and Manovikara Nashaka (alleviator of mental disorders) properties. Hingwadi vati, mentioned in classical texts like Charaka Samhita and Sharangadhara Samhita, supports the gut-brain axis by enhancing digestion and mental clarity through Agni Deepana and Mano Prasadana actions. Marma therapy, described in Sushrut Samhita, helps balances the flow of Prana through vital energy points, thereby promoting mental and emotional stability. This study integrates these approaches, provide evidence-based validation for the holistic management of depression. Aim: To evaluate the comparative efficacy of “Gorakhmundi vati versus Hingwadi vati, with adjuvant therapy of Marma Chikitsa,” in the management of Vishaada (mild depression). Materials and Methods: This randomised controlled trial will be conducted at Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Salod, Wardha, Maharashtra, India, from July 2025 to April 2026. A total of 114 patients will be enrolled and randomly allocated into two groups. Group A will receive Hingwadi vati (500 mg) thrice daily after meals with warm water, combined with Marma therapy. Group B will receive Gorakhmundi vati (500 mg) thrice daily after meals with warm water, combined with Marma therapy. The Hamilton Depression Rating Scale (HDRS) will be used as the primary outcome measure. Patients will be assessed on the 0th day, 15th day, and 30th day. Statistical analysis will include descriptive statistics {mean±Standard Deviation (SD), frequencies, and percentages} and inferential statistics. The paired t-test or Wilcoxon signed-rank test will be used to assess within-group changes, while the Independent t-test or Mann-Whitney U test will be used for between-group comparisons. The Chi-square test or Fisher’s Exact test will evaluate categorical outcomes. A p-value <0.05 will be considered statistically significant.wide, with a complex aetiology involving biological, psychological, and social factors. Despite the availability of pharmacological and psychotherapeutic interventions, the need for integrative and holistic treatment options has gained prominence due to side effects, limited efficacy, and high relapse rates associated with conventional therapies. Need of the study: The WHO identifies depression as a leading global health issue, affecting over 280 million people worldwide. Although modern treatments are effective, they are often accompanied by side effects and high relapse rates, necessitating integrative therapeutic approaches. Ayurveda offers holistic interventions rooted in ancient texts. Gorakhmundi vati, derived from Sphaeranthus indicus, is described in Bhavaprakasha Nighantu as possessing Medhya (brain tonic) and Manovikara Nashaka (alleviator of mental disorders) properties. Hingwadi vati, mentioned in classical texts like Charaka Samhita and Sharangadhara Samhita, supports the gut-brain axis by enhancing digestion and mental clarity through Agni Deepana and Mano Prasadana actions. Marma therapy, described in Sushrut Samhita, helps balances the flow of Prana through vital energy points, thereby promoting mental and emotional stability. This study integrates these approaches, provide evidence-based validation for the holistic management of depression. Aim: To evaluate the comparative efficacy of “Gorakhmundi vati versus Hingwadi vati, with adjuvant therapy of Marma Chikitsa,” in the management of Vishaada (mild depression). Materials and Methods: This randomised controlled trial will be conducted at Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Salod, Wardha, Maharashtra, India, from July 2025 to April 2026. A total of 114 patients will be enrolled and randomly allocated into two groups. Group A will receive Hingwadi vati (500 mg) thrice daily after meals with warm water, combined with Marma therapy. Group B will receive Gorakhmundi vati (500 mg) thrice daily after meals with warm water, combined with Marma therapy. The Hamilton Depression Rating Scale (HDRS) will be used as the primary outcome measure. Patients will be assessed on the 0th day, 15th day, and 30th day. Statistical analysis will include descriptive statistics {mean±Standard Deviation (SD), frequencies, and percentages} and inferential statistics. The paired t-test or Wilcoxon signed-rank test will be used to assess within-group changes, while the Independent t-test or Mann-Whitney U test will be used for between-group comparisons. The Chi-square test or Fisher’s Exact test will evaluate categorical outcomes. A p-value <0.05 will be considered statistically significant.