Introduction

Tension-type headache (TTH) is one of the most prevalent diseases, affecting approximately 1.04 billion individuals worldwide according to the study carried out by the Global Burden of Disease Study in 2019. This significant occurrence has made TTH the third most common medical condition worldwide.^[1] The International Classification of Headache Disorders (ICHD) define tension-type headache as a sensation of tightness or pressure across the forehead or cranial regions accompanied by tenderness in the scalp, cervical, and shoulder musculature. The TTH exerts a considerable socioeconomic burden through reduced productivity, compromised work efficacy, and diminished quality of life, despite its non-fatal nature. The modern lifestyle characterized by increasing competitiveness, occupational stress, psychological pressures, and socioeconomic challenges has substantially contributed to rising incidence of this condition across diverse demographic groups.^[2]

Contemporary epidemiological data reveal that over 80% of TTH cases are associated with depression and anxiety, highlighting the psychosomatic nature of this disorder. Particularly vulnerable are adolescents and young adults navigating educational pressures and career uncertainties, who frequently experience stress-induced headaches. Current allopathic management strategies for TTH primarily utilize analgesics and prophylactic medications, which provide transient symptomatic relief but frequently fail to address the underlying pathophysiology. Furthermore, prolonged pharmacotherapy is associated with significant adverse effects including habituation, medication overuse headache, cognitive impairment, gastrointestinal disorders, and metabolic disturbances. These limitations have prompted patients to seek complementary and alternative therapeutic approaches that offer improved safety profiles and comprehensive management options.

From the Ayurveda perspective, the world's oldest documented healing system originating approximately 5,000 years ago in India, headache disorder is named as Shiroroga or Shirovedna. Ayurvedic researchers such as Acharya Charaka, Vagbhatta, and Sushruta classified headaches into five, ten, and eleven distinct types of Shiroroga, respectively.^[3,4,5]

Symptoms like Bhrumadhyetapa and Lalatatapa Ativedna result from Pitta Dosha association with Vata, characterized by Ushna (hot), Teekshna (sharp), and Sara (mobility) properties. Rasnadi Taila constituents demonstrate multiple therapeutic actions such as Rasna provides anti-inflammatory, analgesic, and Aampachak (metabolic) effects; Shalparni exhibits anti-inflammatory properties; Prushparni acts as a nervine tonic; while Gokuru, Kantakari, and Brihati contribute analgesic and anti-inflammatory effects. The formulation's Tila Taila base, through its Sukshma (subtle), Teeksna (penetrating), and Vyavayi (diffusive) characteristics, penetrates Margavroda (channel blockages) and efficient delivery to target tissues.^[9]

Table 1: List of herbs used in the formulation of Rasnadi Taila

The present study has been conceptualized with the objective of developing a safe, cost-effective, and comprehensive therapeutic protocol for patients suffering from Vatika Shiroroga/TTH that provides both immediate symptomatic relief and sustainable long-term benefits with minimal adverse effects. The investigation aims to evaluate the clinical efficacy of Rasnadi Taila Nasya in alleviating both physical symptoms and psychological components of this condition, thereby addressing the multifactorial nature of tension-type headache and improving overall quality of life for affected individuals.

Materials and Methods

Preparation of Rasnadi Taila

Rasnadi Taila was prepared according to the classical Siddha Sneha Kalpana methodology described by Acharya Sharangadhara.^[10] The formulation utilized a standardized ratio of ingredients: Tila Taila (sesame oil) 1 part (720 ml), Kalka (herb paste) 1/8 part (90 g), water 4 parts (2880 ml), and cow's milk 4 parts (2880 ml).

Plan of study

A clinical study involving 30 patients diagnosed with Vatika Shiroroga was conducted at GACH, Patna. Treatment efficacy was assessed on day 7, with a follow-up on day 30, resulting in a one-month trial duration for each patient. Data analysis was performed using Wilcoxon "Z" test. The study began after obtaining Institutional Ethics Committee approval and CTRI registration (CTRI/2023/03/050177). Written informed consent was taken from all patients at the time of registration before initiating treatment.

Trial drugs preparation

The ingredients for the preparation of the formulation were collected from genuine sources. Rasnadi Taila was prepared in the Pharmacy Department of Government Ayurvedic College and Hospital, Patna, following standardized processing of raw materials. The intervention consisted of Nasya (nasal administration) of Rasnadi Taila at a dose of 8 drops per nostril, administered daily for7-days period.

Criteria of Assessment

A comprehensive documentation was maintained for all 30 trial patients. The efficacy of the therapy was evaluated using both subjective and objective parameters through a multi-dimensional scoring approach. Pain assessment utilized a dual methodology, combining Visual Analogue Scale (VAS) with a 4-point Visual Rating Scale (VRS) and a standardized pain questionnaire. Psychometric assessments were evaluated using validated instruments including Hamilton's Anxiety Rating Scale (HAM-A) and Hamilton's Depression Rating Scale (HDRS), to quantify anxiety and depression elements associated with Vatika Shiroroga.

Results and Discussion

In the present study, 30 patients in the age group of 14-32 years were included, out of which 16 are male and 14 are female. The majority of patients belong to Vata, Pitta and Rajasika Prakriti and had insidious onset, temporal-occipital headache, bilateral, non-pulsatile, moderate headache, increased in evening and chronicity between 6 to 12 months. Most of the patients had disturbed sleep, having irregular bowel habits and irregular dietetic habits. Atisheetajala-Sevena, Vega Dharana, Chinta,

The result revealed the effect of therapies assessed that VAS, symptoms score, HAM-A and HDRS score are shown in Figure 1. The study's quantitative assessments demonstrated statistically significant improvements across all standardized measurement scales. The Visual Analog Scale (VAS) for pain severity showed a 77.08% reduction (from 6.100 to 1.733, p<0.001), indicating substantial pain relief.

Psychiatric evaluations revealed marked improvements in anxiety and depression, with the Hamilton Anxiety Rating Scale (HAM-A) decreasing by 64.63% (from 9.233 to 3.266, p<0.001) and the Hamilton Depression Rating Scale (HDRS) improving by 65.80% (from 8.966 to 3.066, p<0.001). The combined symptoms score demonstrated a 70.92% overall reduction (from 12.566 to 3.733, p<0.001).

and mild improvement in 6.67% (Figure 2). These findings collectively demonstrate that Rasnadi Taila Nasya provides comprehensive therapeutic benefits in Vatika Shiroroga (TTH), effectively addressing both pain and associated psychosomatic components.

Figure 2: Effect of Rasnadi Taila on Vatika Shiroroga after treatment

Modern neurophysiological interpretation suggests Rasnadi Taila may modulate hypothalamic and trigeminal pathways, inhibiting nociceptive signals. Administration via nasal route facilitates rapid absorption through nasal mucosa, enhancing bioavailability through local capillaries, olfactory, and trigeminal nerve pathways, thereby providing superior efficacy compared to oral administration. Rasnadi Taila plays a significant role in the management of Vatika Shiroroga.^[11] The effect of absorbed drugs administered by Nasya Karma is not only limited to the nasal or paranasal area, as the excess medicine reaching to the throat is to be spit out by the patient but also alleviates the vitiated Doshas regarding its Prabhava. The postures in the procedure and fomentation and massage on the face during Nasya Karma may have an impact on the neurovascular junction and drug absorption. The stimulation of the olfactory nerve may affect neuro-endocrinal and neuropsychological levels. This reduces tension and anxiety that have been stored in the primary governing center of our bodies by having a calming impact on the brain and entire nervous system, insomnia and headache.

Conclusion

The increasing prevalence of Vatika Shiroroga (TTH) is a major global burden because it affects person’s quality of life, personal and social relationships, work ability, and working hours.