Evaluation of comparative efficacy of cow milk treated Sida Cordifolia oil nasal administration (Ksheerbala Taila Nasya) versus Convolvulus pluricaulis oil nasal administration (Shankapushpi Taila Nasya) in the management of primary insomnia (Anidra)- a trial protocol

Introduction

One of the most well-known traditional medicinal practices from antiquity that has survived and developed over time is ayurveda. This system will endure for many more millennia because of the extensive knowledge of natural remedies, the linkages between environmental factors and human body composition and performance, and the cosmos's interconnected elements that have an impact on living things.¹

Panchkarma (detoxification therapy) is an Ayurvedic detoxifying retreat technique. Panchkarma is a detoxification and relaxing approach that has been used for centuries to help people cope with seasonal and societal changes. Benefits of this therapy include improvements in one's perception of social support, quality of life, and healthy behavior.²

For daily activities, focus, alertness, mental and physical performance, etc., sleep is crucial. Sleep disruptions can lead to serious health issues and other difficulties.

An individual who struggles to fall or stay asleep is said to have insomnia. Short-term and longer insomnia are both possible; short-term insomnia can last anywhere from one night to a few weeks, while long-term insomnia develops when sleep problems endure for longer than three months. Primary and secondary insomnia are the two categories of the condition. In contrast to secondary insomnia, which occurs when a patient's sleep problems are brought on by an underlying health problem such as asthma, cancer, heartburn, pain, medications, or other substances such as alcohol whereas primary insomnia is characterized by the absence of any other health concerns in the patient.³

The three pillars of life in Ayurveda are food (Ahara), sleep (Nindra), celibacy (Bramhacharya), according to a Hindu religious teacher, insomnia is mentioned in the Charaka Samhita, Susruta Samhita, and Astang Hridaya, among other ayurvedic classic texts.⁴ Insomnia is defined in eight undesirable conditions (Asthonindtiya Adhyaah) by spiritual guide Charak, and insomnia is mentioned in Maharoga Adhyaya as one of the 80 types of Vata disease.⁵ It is described in the Susruta Samhita in the Sharir Sthana under Garbhavyakaran Sharir.

The causes of insomnia, according to Acharya Sushruta, are Santapa of vaata, pitta, and mana, as well as physical harm. Insomnia is caused by a variety of factors, the most prevalent of which are listed above.⁶ In Astang Hridiya spritual guide Vaghbhat has quoted the symptoms of insomnia as following throbbing pain, heaviness in head, yawning, stiffness all over body, exhaustion, giddiness, indigestion, drowsiness it may further causes Vata disease.⁷ It is said that a vitiated Vata Dosha sets off the effects of insomnia, hence balancing Vata Dosha can provide relief in the event of insomnia.

Insomnia is said to affect 9% of the general population, with 30% of people experiencing it occasionally. 18.6% of the cohort research participants said they had sleeplessness. A north Indian urban population was found to have a greater prevalence of sleep disorders (28%) that affect the onset and maintenance of sleep.⁸

Convolvulus pluricaulis herb is a memory enhancer that can also be used as a brain tonic to stimulate brain and brain function. It improves focus and learning capacities while also assisting in the treatment of insomnia, stress, depression, and mental stress.

Convolvulus pluricaulis characterizes bitter taste. It shows oily, sticky, and slimy property, cold potency, and sweet metabolic property help in preventing a variety of health problem that disrupt sleep.

The intellectual effect boosts mental power and hence resists depression and anxiety etiology, resulting in restful sleep. Shankhpushpi is known to lower cortisol (the stress hormone), reducing stress and improving the quality and quality of natural sleep. Gastric problems can disrupt sleep, but this magical herbal remedy aids digestion and prevents reflux and gas accumulation, allowing you to sleep better. Chemical components found in Shankhpushpi, such as Shankhapushpine, convoline, convolidine, confoline, myristic acids, scopoletin, -sitosterol, tetratriacontane acids, flavonoid-kaempferol, and phytosterols, help to boost general health and ward off sickness- resulting in insomnia.⁹

According to Ayurveda, the entrance to the brain is through the nose. Nasal administration refers to the practice of administering medication nasally. It is the most important therapy as it is used for the treatment of upper clavicular disease so in some places it has been given first place in the sequence of detoxification for e.g., in the chapter of Apamarga Tanduliyam of Charaka Samhita Sutrasthana.

The medication used in nasal administration enters the brain via a pathway known as the Vital point (Shringataka Marma), where it destroys the connection between toxins and brain tissues before transporting those molecules to the nose, where secretions force them out. People with brain illnesses are frequently given large amounts of unwanted medications by mouth. This may become troublesome for a patient's health if they live a long time or if they have a chronic ailment. Because of the brain's blood barrier restriction to oral use, tablets delivered orally are an incredibly poor approach to deliver medications to the brain when it comes to brain illnesses. Sneha can cross the blood-brain barrier because to its lipophilic activity, which releases the active principles of the constituents where they are needed. The likelihood that a medicine will cross the blood-brain barrier increases with its lipophilicity.¹⁰

Need of the study

In present era, Digital media and smart phones have raised productivity demands while blurring the boundaries between work and personal life. All these factors, including reduced free time, a faster pace of life, and stress, contribute to sleep deprivation, which has major medical and emotional consequences, health, job performance, and overall quality of life are all factors to consider.

Modern medical research has therapies such as hypnotics, sedatives, anxiolytics, and psychotropics, but there is still no definitive cure for insomnia, and these medications have their own set of limitations due to their side effects.¹¹ Due to their addiction and side effects, current anxiolytic medications have a limited application.¹²

As a result, these drugs cannot be used for an extended period. As a result, it is crucial to seek out drugs from natural systems of medicine such as Ayurveda that are both safe and successful in treating insomnia patients. Hence this study is conducted with the aim evaluation of comparative efficacy of cow milk treated Sida Cordifolia oil nasal administration (Ksheerbala Taila Nasya) versus Convolvulus Pluricaulis oil nasal administration (Shankapushpi Taila Nasya) in the management of primary insomnia (Anidra).

Aim

Evaluation of Comparative Efficacy of cow milk treated sida cordifolia oil nasal administration (Ksheerbala Taila Nasya) versus convolvulus pluricaulis oil nasal administration (Shankapushpi Taila Nasya) in the Management of Primary Insomnia (Anidra).

Protocol

Study setting

The patient of Insomnia will be recruited from the panchakarma OPD and IPD of Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod(H), and from peripheral camps.

A total of 60 patients will be recruited for the study. They will be randomly divided into two groups. Group A will be given nasal administration with Ksheerbala oil, Group B will be given nasal administration with Shankhapushpi. All the baseline parameters will be recorded at the start of the study. The patients will undergo treatment for 15 days for both groups. After treatment, all the parameters will be recorded at the 16^th and 30^th day.

Guideline: Used the SPIRIT guideline for the study.

Case definition: Patient of insomnia (having age group between 20-60 year of irrespective gender) diagnosed based on Insomnia Severity Index.

Sampling procedure: Randomization computer generated table.

Type of Study: Interventional Study

Study design: Refer to Figure 1.

Figure 1. GANTT Chart for study (Timeline).

Study design: Randomization standard control double blind superiority clinical trial.

Roles and Responsibilities of committees: The study will start after clearance from IEC of Mahatma Gandhi Ayurved College Hospital and Research Centre, Salod(H), Wardha. And after CTRI registration Ref.No. MGACHRC/IEC/June-2023/707

The committee will decide on the endpoint and oversee the trial as it progresses.

The researcher will assess any adverse events and will report to the ethics committee.

Nasal administration complications and its management

There are two varieties of complication, according to spiritual guide Sushruta: Dosha Vriddhi Janya, Secondly, Dosha Kshaya Janya Vyapad. Shodhana and Shaman Chikitsha should be stated in the case of Dosha Vriddhi Janya Vyapad, while Brihmana Chikitsa is recommended in the case of Dosha Kshaya Janya Vyapa.

Discussion

The three Ayurvedic sthambhas—Vata, Pitta, and Kapha—oversee all the body's essential processes. When the three Sthambhas are in an equilibrium state, a person is said to be healthy. There are three Pillars (Upsthambha) to support these Sthambha.

Food (Ahara), Sleep (Nindra) and Celibacy (Brahmacharya) are the three. Upsthambha is one of the main forces that contribute to and support life. Such Pillars (Upsthambha) increase the strength of an individual. Sleep (Nindra) has an impact on both mental and physical elements. Nidra is therefore crucial for both physical and emotional wellness.

Work, ageing, illnesses, constitution, and some Doshas like Vata and Pitta were only a few of the many causes of sleep deprivation that were explained by Ayurveda. These elements have a direct impact on sleep and result in sleep loss. Loss of sleep can occur for a variety of causes, including disease, stress, ageing, pain, mental illness, and others, according to modern scientific theory. Insomnia was included in the 80 Vataja disease by Charaka and Kashyapa.

The herb Convolvulus Pluricaulis (Shankhpushpi), a memory enhancer utilized as a brain tonic to stimulate cognition and brain function. It improves focus and learning skills and aids in the treatment of conditions such as depression, stress, and mental tiredness.

The Medhya effect increases strength of mind, which helps one resist the pathophysiology of depression and anxiety and promotes restful sleep. Convolvulus Pluricaulis (Shankhpushpi) is said to improve the quality and length of natural sleep by lowering cortisol (the stress hormone) levels, which in turn reduces stress.

The chemical components of Shankhpushpi, including flavonoids kaempferol and phytosterols, myristic acids, scopoletin, -sitosterol, tetratriacontane acids, and convoline, aid to promote general health and prevent disease-related sleeplessness.

Since the nose serves as the brain's entrance, this procedure allows for the administration of medications in accordance with the severity of the patient's illness. It is a very effective therapy modality that is included in the arsenal of purification therapies due to the numerous classifications and varieties of nasal procedure that have been stated, as well as the various methods of medication delivery. Following a thorough examination of the patient and the selection of a particular nasal procedure, pre-procedure, procedure, and post procedure can be readily carried out systematically. The method's likely mode of action indicates that it is successful in producing the desired effects in the treatment of insomnia.

Conclusion

Convolvulus Pluricaulis oil nasal administration may be more effective than cow milk treated with Sida Cordifolia oil nasal administration in treating insomnia while having fewer adverse effects.

Consent

Both written and verbal consent of the patient will be taken before conducting the trial in the local language while explaining every aspect of the study. The researcher will take consent from trial participants.

Dissemination

This protocol will be further published as a thesis to disseminate the study of Insomnia. The study protocol provides a detailed overview of the study design, methodology, data collection, data analysis plan, and ethical consideration. By disseminating this protocol, we hope to advance knowledge in the field of research.

Study status

We have started enrolling patients.

Ayurvedic Terminology and its translation