Trial on nirgundyadi gritha as add-on for partial seizures.

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Journal name: World Journal of Pharmaceutical Research
Original article title: An open clinical trial to assess the efficacy of nirgundyadi gritha as an add-on therapy along with aed in the management of apasmara wsr to partial seizure with secondary generalization
The WJPR includes peer-reviewed publications such as scientific research papers, reports, review articles, company news, thesis reports and case studies in areas of Biology, Pharmaceutical industries and Chemical technology while incorporating ancient fields of knowledge such combining Ayurveda with scientific data.
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Author:

C Ambili , M Jithesh, S Ram manohar


World Journal of Pharmaceutical Research:

(An ISO 9001:2015 Certified International Journal)

Full text available for: An open clinical trial to assess the efficacy of nirgundyadi gritha as an add-on therapy along with aed in the management of apasmara wsr to partial seizure with secondary generalization

Source type: An International Peer Reviewed Journal for Pharmaceutical and Medical and Scientific Research


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Summary of article contents:

Introduction

Epilepsy, ranked as the most common neurological disorder after stroke and dementia, impacts a significant portion of the population, particularly those aged 1-20 years. The condition often stigmatizes individuals, leading to challenges in education, employment, and social acceptance. Ayurveda, with its holistic approach to wellness, describes epilepsy as 'Apasmara', attributing not only physical but also psychological factors to its manifestation. The Ayurvedic literature cites various management strategies, yet empirical evidence regarding the efficacy of Ayurvedic remedies remains limited. This study evaluates the effectiveness of Nirgundyadi gritha as an adjunctive therapy alongside antiepileptic drugs (AED) to manage Apasmara, specifically in cases of partial seizures with secondary generalization.

Efficacy of Nirgundyadi Gritha

The primary objective of this clinical trial was to assess the efficacy of Nirgundyadi gritha, a classical Ayurvedic preparation, as an add-on therapy to existing AEDs in treating partial seizures with secondary generalization. An open-label, uncontrolled clinical trial was conducted with 20 participants over a period of two months, followed by a one-month follow-up. Participants showed significant improvements in key metrics, including frequency, severity, duration of seizures, and postictal symptoms. The results indicated a statistically significant reduction in these parameters, highlighting the potential of Nirgundyadi gritha in enhancing the management of Apasmara.

Clinical Characteristics of Participants

Demographic data revealed interesting insights about the participants. The majority (70%) were male, predominantly aged 21-25 years, and most presented with a significant educational and socio-economic background that correlated with a higher prevalence of epilepsy in lower socio-economic groups. The study noted various precipitating factors for seizures, with sleep deprivation reported by 50% of the participants. The psychological landscape of those with epilepsy was also evident, with a portion struggling with anxiety and depression, indicating the need for comprehensive management approaches that address both the medical and psychological facets of the disease.

Limitations and Implications of Current AEDs

Despite advancements in the management of epilepsy through modern AEDs, issues such as side effects, cognitive impairments, and inadequate seizure control persist for a significant minority of patients. This underlines the pressing need for additional therapy options, such as Ayurvedic preparations. The study emphasized that Ayurvedic formulations, like Nirgundyadi gritha, not only help manage acute symptoms but also contribute to improving overall quality of life by addressing the intertwined physical and psychological aspects of Apasmara.

Conclusion

The trial findings suggest that Nirgundyadi gritha serves as a beneficial add-on to traditional AED therapy, demonstrating significant efficacy in the management of Apasmara related to partial seizures and enhancing patients' quality of life. This study contributes to the growing evidence base for Ayurvedic interventions in neurological conditions, advocating for further scientific exploration of traditional remedies to address the multifaceted challenges faced by patients with epilepsy. By integrating Ayurvedic insights into modern therapeutic regimes, there is potential for improved outcomes and holistic care for individuals afflicted by this often debilitating condition.

FAQ section (important questions/answers):

What is the aim of the study on Nirgundyadi gritha?

The study aims to assess the efficacy of Nirgundyadi gritha as an add-on therapy in managing Apasmara, a condition related to partial seizures with secondary generalization.

What was the sample size and duration of the study?

The study involved 20 participants over a duration of two months, followed by a one-month follow-up to evaluate the effectiveness of the treatment.

How is Apasmara defined in Ayurvedic literature?

In Ayurveda, Apasmara is described as a temporary loss of consciousness, characterized by a disturbance in awareness, memory, and mental strength during seizures.

What are the key ingredients of Nirgundyadi gritha?

Nirgundyadi gritha contains 36 herbal ingredients, including Nirgundi, Lasuna, and Aswagandha, known for their antiepileptic and restorative properties beneficial for neurological disorders.

What were the findings related to seizure frequency and severity?

The study found statistically significant reductions in seizure frequency and severity, with relief percentages of 28.94% and 24.4%, respectively, after two months of treatment.

What is the significance of this research for epilepsy management?

The findings suggest that Nirgundyadi gritha can be an effective complementary treatment in managing epilepsy, highlighting the potential role of Ayurvedic medicine in enhancing patient quality of life.

Glossary definitions and references:

Scientific and Ayurvedic Glossary list for “Trial on nirgundyadi gritha as add-on for partial seizures.”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.

1) Epilepsy:
Epilepsy is a neurological disorder characterized by recurrent seizures due to abnormal electrical activity in the brain. It greatly affects the individual's quality of life by causing unpredictability, stigma, and can lead to various social and psychological issues. Understanding epilepsy is vital for creating effective interventions and support structures for those affected.

2) Study (Studying):
The study enhances our understanding of complex interventions in medical practice, particularly the use of herbal formulations in treating epilepsy. It investigates the efficacy of Nirgundyadi gritha as an add-on therapy to traditional antiepileptic drugs, providing insight into alternative medicine approaches and their potential benefits in managing chronic conditions.

3) Drug:
The term 'drug' encompasses substances used for therapeutic purposes. In this context, Nirgundyadi gritha is highlighted as an Ayurvedic preparation that may provide significant relief from seizure frequency and severity. Understanding the role of this drug within both a modern and traditional framework is essential for effective treatment strategies.

4) Apasmara (Apasmāra):
Apasmara is the Ayurvedic term for epilepsy, characterized by loss of consciousness and convulsions. The nomenclature and understanding of Apasmara in Ayurveda provide crucial insights into holistic management approaches, integrating both physical and psychological elements, which may contribute to improved outcomes in affected individuals.

5) Disease:
In the context of this study, disease refers to epilepsy and related disorders that significantly impact an individual's mental and physical well-being. The term emphasizes the need for comprehensive approaches that address both the physiological aspects and the social implications of living with such chronic conditions.

6) Nirgundyadi (Nirguṇḍyādi):
Nirgundyadi refers to a specific Ayurvedic formulation containing various herbs believed to have therapeutic effects on neurological conditions like epilepsy. Its effectiveness in restoring balance among the body’s doshas and improving the overall health of individuals is crucial for exploring alternative treatment avenues in modern medicine.

7) Ayurveda (Āyurveda, Ayus-veda):
Ayurveda is an ancient Indian system of medicine that emphasizes balance and harmony in the body. It provides a holistic approach to health, encompassing diet, lifestyle, and herbal treatments, making it relevant in managing chronic conditions like epilepsy and improving the quality of life of affected individuals.

8) Post:
Post refers to the period after treatment or intervention where the outcomes and effectiveness of the therapy (such as Nirgundyadi gritha) are critically evaluated. Monitoring post-treatment effects is essential to ensure sustained benefits and to make necessary adjustments to therapeutic strategies.

9) Ghrita (Ghṛta):
Ghrita, or ghee, is considered a revered substance in Ayurveda, often used in medicinal preparations. Its properties are recognized as bringing balance and enhancing the absorption of herbs in the body. The lipid-rich nature of ghrita can facilitate the delivery of active compounds to target organs, especially the brain.

10) Life:
In this context, life refers to the quality and experiences of individuals living with epilepsy. The impact of seizures on personal, social, and professional facets of life underscores the necessity for effective treatments like Nirgundyadi gritha to enhance overall well-being and social integration.

11) Dosha (Dosa, Doṣa, Dosā, Doṣā, Ḍosā):
Doshas are the fundamental principles in Ayurveda that govern physiological and psychological functions in the body. They include Vata, Pitta, and Kapha, playing a role in health and disease. Understanding dosha imbalances is crucial for developing effective Ayurvedic treatments for conditions like Apasmara.

12) Medicine:
Medicine encompasses the various practices, therapies, and interventions used to treat diseases. This study explores both modern antiepileptic drugs and traditional Ayurvedic medicines like Nirgundyadi gritha, highlighting the importance of integrating diverse medical knowledge for holistic patient care.

13) Activity:
Activity refers to the normal functioning of neurons and brain activity, which can be disrupted in epilepsy. Understanding the patterns of neuronal activity helps in diagnosing seizures and identifying effective treatments aimed at restoring normal brain function.

14) Quality:
Quality in this study refers to the overall well-being and life experience of individuals suffering from epilepsy. Effective management strategies aim to improve quality of life by reducing seizure frequency and severity, enhancing mental health, and instilling social acceptance.

15) India:
India, with a significant population suffering from epilepsy, serves as the backdrop for this study. The cultural and social context in India, including the perceptions of epilepsy, informs the approach to treatment and support for individuals dealing with this disorder.

16) Education:
Education plays a crucial role in the lives of individuals with epilepsy, impacting their societal acceptance and employment opportunities. This study reflects the need to raise awareness and provide resources that can help mitigate educational challenges faced by those with the condition.

17) Marriage:
Marriage and personal relationships are areas significantly affected by epilepsy. Individuals with epilepsy may face stigmatization and challenges in forming marital relationships. This socio-cultural reality underscores the need for inclusive support structures that foster healthy relationships and social acceptance.

18) Cikitsa (Cikitsā):
Cikitsa refers to the therapeutic measures outlined in Ayurveda for managing diseases. This study focuses on the cikitsa for Apasmara, emphasizing a combination of pharmacological and holistic methods that address both physical symptoms and psychological factors.

19) Prakriti (Prakṛti):
Prakrti represents the inherent constitution or nature of an individual in Ayurveda, influencing health outcomes. Assessing an individual's prakrti is essential for tailoring personalized treatments, particularly for conditions like epilepsy that may manifest differently across individuals.

20) Mud:
Mood is an important psychological aspect evaluated in individuals with epilepsy. The study highlights how psychological factors, such as anxiety and depression, can affect seizure frequency, emphasizing the need for comprehensive treatment strategies that address both emotional and physical health.

21) Observation:
Observation relates to the careful monitoring and assessment of patient responses to treatment throughout the study. Systematic observations help in evaluating the effectiveness of therapies like Nirgundyadi gritha and contribute to understanding epilepsy's dynamic nature.

22) Rasayana (Rasa-ayana, Rasāyana, Rāsāyana):
Rasayana is a category of Ayurvedic medicine focused on rejuvenation and enhancing vitality. Ingredients in Nirgundyadi gritha may have rasayana properties, aiding in the management of mental and physical symptoms associated with epilepsy and fostering overall resilience in patients.

23) Samhita (Saṃhitā, Saṃhita):
Samhita refers to a collection of ancient texts that guide Ayurvedic practices. The Caraka Samhita, in particular, provides comprehensive insights into managing conditions like Apasmara, emphasizing the integration of physical, mental, and spiritual approaches in treatment.

24) Citraka:
Citraka is an herb included in Ayurvedic formulations believed to possess therapeutic properties, particularly in digestive health and metabolic regulation. Its inclusion in Nirgundyadi gritha may contribute to its effectiveness in treating epilepsy-related symptoms.

25) Shodhana (Śodhana, Sodhana):
Sodhana refers to detoxification procedures in Ayurveda aimed at purging harmful substances from the body. In the context of epilepsy, sodhana methods may be essential for restoring balance among the doshas and enhancing the efficacy of treatments.

26) Smriti (Smṛti):
Smriti relates to memory or consciousness in the context of Apasmara. The disturbances in smriti during seizures highlight the cognitive implications of epilepsy and the importance of treatments that aim to stabilize mental functions.

27) Caraka (Cāraka, Cārāka):
Caraka, an ancient Ayurvedic sage, authored the Caraka Samhita, which is a foundational text of Ayurveda. His contributions included comprehensive diagnostics and treatment strategies for various ailments, including epilepsy, illustrating the depth of Ayurvedic knowledge in addressing neurological conditions.

28) Vaidya:
A Vaidya is a traditional Ayurvedic doctor trained in herbal medicine and holistic health practices. In the study, the role of Vaidyas is emphasized in administering Nirgundyadi gritha and guiding patients through treatment protocols tailored to their specific needs.

29) Lashuna (Lasuṇa, Lasuna, Laśuna, Laśūna):
Lasuna, or garlic, is known for its medicinal properties in Ayurveda, including its potential anti-convulsant effects. Its inclusion in Nirgundyadi gritha underlines the importance of combining various herbs to enhance therapeutic efficacy for conditions like epilepsy.

30) Pitta (Pītta, Piṭṭā):
Pitta is one of the three doshas in Ayurveda that represents metabolic processes. Individuals with a Pitta dosha may exhibit specific attributes, affecting their susceptibility to conditions like epilepsy. Understanding this balance is crucial for personalized treatment protocols.

31) Kapha:
Kapha, another dosha in Ayurvedic medicine, embodies qualities of stability and moisture. The interplay of Kapha with other doshas is essential for understanding the overall health profile of an individual, especially in relation to managing chronic disorders like epilepsy.

32) Table:
Table refers to the structured presentation of statistical data reflecting the outcomes of this study. It provides concise summaries of treatment efficacy and correlational findings, aiding in the clarity and dissemination of important research results.

33) Vaca (Vācā, Vacā, Vāca):
Vaca, also known as Sweet Flag, is an essential herb in Ayurvedic medicine recognized for its neurological benefits. Its incorporation into treatments for conditions like epilepsy highlights the ancient understanding of herbs’ role in brain health.

34) Male (Mālē):
Male refers to the gender distribution of study participants. The prevalence of epilepsy in males, compared to females, is a significant consideration in developing targeted outreach and treatment strategies in public health initiatives.

35) Food:
Food choices can significantly impact health and well-being, particularly in epilepsy management. The study acknowledges dietary habits, such as mixed versus vegetarian diets, and their correlation with seizure occurrences and overall health.

36) Ghi (Ghī, Ghee):
Ghee, or clarified butter, is pivotal in Ayurvedic medicine for its nourishing and therapeutic properties. Its unique composition aids in delivering herbal medicines efficiently across biological barriers, enhancing treatment outcomes for conditions such as epilepsy.

37) Caraka-samhita (Caraka-saṃhitā):
The Caraka-samhita is a classical text in Ayurveda covering various medical topics, including the diagnosis and management of neurological disorders. Its guidelines are integral for practitioners and researchers exploring effective traditional remedies for epilepsy.

38) Yashtimadhu (Yaṣṭimadhu, Yashti-madhu, Yaṣṭīmadhu):
Yashtimadhu, or licorice, is valued in Ayurveda for its soothing and restorative properties. Its presence in herbal formulations aimed at neurological conditions emphasizes the importance of integrating specific herbs to support brain health and alleviate symptoms.

39) Kaphapitta (Kapha-pitta):
Kapha-Pitta refers to a specific dosha combination that may further refine treatment strategies in Ayurveda. Understanding the unique characteristics and health implications of this combination can enhance the effectiveness of interventions for individuals with epilepsy.

40) Performance:
Performance in this context relates to the ability of individuals to function normally in daily life despite the challenges posed by epilepsy. Effective treatments aim to enhance performance by reducing seizure frequency and improving mental health.

41) Measurement:
Measurement is crucial in the study for evaluating the therapeutic effects of Nirgundyadi gritha. It involves quantifying parameters like seizure frequency and duration, enabling researchers to assess overall treatment effectiveness and make informed conclusions.

42) Discussion:
Discussion in this study leads to insights about the implications of Nirgundyadi gritha in managing epilepsy. It highlights the need for further research into traditional remedies and their application in modern medical practices for holistic patient care.

43) Developing:
Developing refers to the ongoing efforts to enhance understanding and treatment modalities for epilepsy. The study contributes to this endeavor by exploring Ayurvedic approaches, potentially influencing treatment paradigms in both traditional and contemporary medical contexts.

44) Depression:
Depression is a common comorbidity among individuals with epilepsy, often exacerbated by stigma and the social burden of the condition. Addressing mental health in treatment protocols is crucial for improving the overall well-being of affected individuals.

45) Alcoholism:
Alcoholism is a significant concern in the management of epilepsy, as it can trigger seizures and complicate treatment. Excluding individuals with a history of substance abuse is essential for ensuring accurate assessment of treatment efficacy.

46) Garavisha (Garaviṣa, Gara-visha):
Garavisha refers to poison, emphasizing Ayurveda's comprehensive approach to health that includes detoxification and addressing the consequences of harmful substances. Its relevance lies in understanding the holistic treatment options available for chronic conditions like epilepsy.

47) Substance:
Substance refers to various elements affecting health, including both medicinal preparations and potentially harmful materials. The distinction between beneficial herbs and detrimental substances is critical in developing effective treatment strategies for epilepsy management.

48) Attending:
Attending refers to participants in the study who seek treatment. Their experiences and responses are vital for understanding the efficacy of Nirgundyadi gritha and assessing the real-world implications of Ayurvedic treatments for epilepsy.

49) Affection:
Affection in this context relates to the emotional and psychological connection individuals have with their health and treatment. Enhancing affection towards well-being can motivate patients to adhere to treatment regimens, ultimately improving health outcomes.

50) Triphala (Triphalā, Tri-phala):
Triphala, a well-known Ayurvedic formulation, is believed to promote digestive health and detoxification. Its inclusion in treatments suggests a multifaceted approach to addressing the underlying issues associated with epilepsy, enhancing overall therapeutic outcomes.

51) Pravesha (Praveśa):
Pravesha refers to the concept of entering or manifestation in Ayurveda concerning the onset of conditions. In epilepsy, analyzing pravesha could provide insights into triggers and mechanisms leading to seizures, facilitating better preventive strategies.

52) Nirgundi (Nirguṇḍī, Nirgumdi):
Nirgundi is an herb known for its therapeutic properties, particularly in neurological disorders. Its inclusion in preparations like Nirgundyadi gritha highlights the importance of combining various substances with established benefits for holistic treatment approaches.

53) Matavan (Mātavaṉ, Maṭavaṉ, Mātavāṉ):
Madhavan is mentioned as the author of the research, emphasizing individual contributions to the study. Authors’ perspectives shape the interpretation and dissemination of research findings in the medical community, influencing future approaches to treatment.

54) Snehana:
Snehana refers to the therapeutic application of oil or ghee in Ayurveda, aiming to improve bodily functions and deliver medicinal properties effectively. This technique integrates physical and mental aspects of healing, particularly relevant in treating conditions like epilepsy.

55) Anupana (Anupāna):
Anupana refers to the medium or supportive substance, usually warm water, that accompanies herbal medicine to aid absorption and efficacy. The choice of anupana is significant in Ayurvedic practice to enhance the overall therapeutic outcomes for patients.

56) Company:
The term company in this study may refer to the affiliation of Ayurvedic practices with modern approaches, illustrating a trend towards holistic and interdisciplinary treatment modalities aimed at enhancing patient welfare in epilepsy care.

57) Falling:
Falling can be a significant concern during seizures, as it poses risks of injury and trauma for individuals with epilepsy. Understanding and addressing the mechanisms of falling during seizures is crucial for ensuring safety and effective management.

58) Anxiety:
Anxiety is a common psychological issue associated with epilepsy. Patients often experience anxiety about seizures, which can exacerbate their condition. Addressing both anxiety and seizure management is vital for overall quality of life improvements.

59) Mantra (Māntra, Mamtra):
Mantra refers to the spiritual or meditative practices often incorporated into Ayurvedic healing. In the context of Apasmara, mantras may enhance treatment outcomes by fostering mental well-being and emotional resilience in patients.

60) Gamana:
Gamana refers to movement or transportation in Ayurveda, signifying the delivery of therapeutic substances within the body. Understanding the principles of gamana supports the design of effective herbal formulations meant to treat neurological issues like epilepsy.

61) Samana (Śamana, Samāna, Samaṇa, Samanā, Śāmana, Sāmana, Shamana, Samānā):
Samana refers to the balancing treatment approaches in Ayurveda meant to restore equilibrium within the body's doshas. The concept highlights the necessity for a tailored approach to managing conditions like Apasmara through individualized therapeutic strategies.

62) Gutika (Guṭika, Guṭikā):
Gutika refers to a form of Ayurvedic medicine that is typically presented as pills or tablets. Its formulation method offers convenience and precise dosing options, making it an important aspect of delivering therapeutic interventions for epilepsy.

63) Yashti (Yaṣṭi, Yaṣṭī, Yastī):
Yashti, or licorice, plays a role in balancing doshas and is recognized for its soothing properties. Its presence in Ayurvedic formulations for epilepsy underscores the significance of herbal synergy in achieving desired therapeutic efficacy.

64) Kerala (Keralā):
Kerala is a region in India renowned for its rich tradition of Ayurveda. The state's cultural acceptance of ancient healing practices makes it a significant area for studying and implementing traditional therapies like Nirgundyadi gritha for treating epilepsy.

65) Anjana (Añjana, Anjanā, Añjanā, Āñjana, Amjana, Anjāna):
Anjana refers to the application of medicinal substances to the eyes. While primarily associated with ocular treatments, the concept symbolizes holistic approaches in Ayurveda, which integrates various body systems in managing conditions like epilepsy.

66) Daivya:
Daivya relates to divine or spiritual elements in Ayurvedic treatments, often incorporated as part of holistic healing practices. This aspect emphasizes the interplay between mental, emotional, and spiritual well-being in managing neurological disorders.

67) Nasya (Nashya, Nāśya, Nāsya):
Nasya refers to an Ayurvedic therapy involving herbal preparations administered through the nasal passages. It illustrates the diverse methods of delivering treatment aimed at promoting brain health and addressing neurological conditions such as epilepsy.

68) Ratna (Ratnā):
Ratna signifies precious stones or jewels in Ayurvedic contexts, sometimes incorporated in traditional healing practices. Understanding their symbolic and potential therapeutic roles could enrich holistic approaches for enhancing peace and balance in patients' lives.

69) Ushna (Uṣṇa, Uṣṇā):
Ushna refers to the heating property of substances in Ayurveda. Its application in treatments like Nirgundyadi gritha is believed to enhance metabolic functions and promote the efficacy of herbal preparations in managing conditions such as epilepsy.

70) Yukti:
Yukti represents the intelligence or reasoning applied in Ayurvedic practices to make informed decisions regarding treatment protocols. Understanding yukti is essential for creating effective therapeutic approaches in managing conditions like Apasmara.

71) Water:
Water, often used as an anupana in Ayurvedic treatments, aids in the absorption of herbal substances. It highlights the importance of incorporating supportive measures in treatment regimens to enhance the overall effectiveness of therapy.

72) Death:
Death is a significant concern for individuals with epilepsy due to the associated risks, such as Sudden Unexpected Death in Epilepsy (SUDEP). Highlighting the importance of effective treatment strategies aims to mitigate these risks and improve life expectancy.

73) Grief:
Grief encompasses the emotional pain experienced by individuals and their families dealing with epilepsy. The psychosocial implications of the disorder underscore the need for comprehensive support systems that address emotional well-being alongside medical treatment.

74) Blood:
Blood represents the vital fluid in Ayurveda that carries nutrients and energy throughout the body. Understanding its role in maintaining health allows for more targeted therapeutic interventions to address conditions like epilepsy, enhancing bodily equilibrium.

75) Anger (Angry):
Anger, as an emotional response, can significantly affect individuals with epilepsy, leading to increased stress and triggering seizures. Effective treatment approaches must address emotional regulation alongside physical symptoms for comprehensive patient care.

[Note: The above list is limited to 75. Total glossary definitions available: 88]

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