Description:

FIELD OF THE INVENTION
The present invention relates to the field of medical science (Ayurveda), and more particularly, the present invention relates to the crystalline salt composition for enhanced jal-neti experience.
BACKGROUND FOR THE INVENTION:
The following discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was published, known, or part of the common general knowledge in any jurisdiction as of the priority date of the application. The details provided herein the background if belongs to any publication is taken only as a reference for describing the problems, in general terminologies or principles or both of science and technology in the associated prior art.
Neti Kriya, or Nasikagra Dhauti, is a yogic purification technique detailed in the Hatha Yogic texts mainly in HathaYog Pradipika (HYP) and Geranda Samhita (GS). This practice entails cleansing the nasal passages with a thread or catheter to eliminate impurities and enhance respiratory health. As described in the HYP (II.29-31), Neti Kriya involves inserting a thread or catheter (Neti) into one nostril and guiding it through to the throat. The thread is then withdrawn, carrying mucus, dirt, and other impurities. This process is repeated several times, alternating between the two nostrils. The GS (I.55-56) provides further instructions, recommending a thread made from cotton or silk, and stressing the necessity of purifying the thread before use (Digambarji and Gharote, 1997; Sahay, 2021). The GS also advises practising Neti Kriya regularly, ideally in the early morning, to achieve the best results.
The Neti Kriya, also known as Sutra-Neti, as outlined in traditional yoga texts, includes removing excess mucus, preventing respiratory diseases, and improving olfactory function. Furthermore, Neti Kriya is believed to help balance the nervous system, thereby preparing the body for more advanced yogic practices (Mallinson, 2004; Sarma et al., 2022).
Sutra-Neti, described in traditional Hatha Yoga texts, involves inserting a thread into the nasal passage to remove impurities. Considered more intense and riskier, especially for new practitioners, this practice requires inserting a solid thread from the nostril to the throat. As a safer alternative, several yoga commentaries and publications have introduced Jal-Neti, as a modified and effective variation of Sutra-Neti (Muktibodhananda, 2000; Saraswati, 2011). In contrast, Jal-Neti is a more gentle and accessible practice that involves rinsing the nasal passages with the saline solution (Jal) using a neti pot. Jal-Neti can be seen as a modification of Sutra-Neti, as it adapts the concept of nasal cleansing using a more gentle and accessible method. This traditional adaptation offers a more approachable and user-friendly alternative to Sutra-Neti with a similar impact (Sarma et al., 2022).
Moreover, Jal-Neti has been employed for centuries to maintain upper airway hygiene through the utilisation of lukewarm salted water. The saline irrigation inherent to this practice has been empirically shown to decrease the concentration of inflammatory mediators, including histamine and leukotriene, in nasal secretions. This reduction in inflammation subsequently leads to a decrease in the severity and frequency of sinusitis, as well as a diminished need for antibiotic therapy. Furthermore, Jal-Neti has been found to restore the competency of the nasal mucosa, thereby enhancing overall nasal function (Bastier et al., 2015; Head et al., 2018; Khianey and Oppenheimer, 2012; Li et al., 2019; Mamidi and Gupta, 2023; Ragab et al., 2015; Sarma et al., 2022). Regular practice of Nasal irrigation (Jal-Neti) has been clinically proven to improve nasal symptoms and overall health status in patients with sinusitis. This underscores the potential of Jal-Neti as a complementary therapeutic approach in the management of sinusitis and other nasal disorders (Meera et al., 2020; Sarma et al., 2022).
Despite being practised for thousands of years, Jal-Neti is considered a safe procedure when proper training is provided beforehand. However, mild risks and adverse effects have been observed (Burton et al., 2020; Meera et al., 2020; Sarma et al., 2022):
Transient risks: A small amount of irrigating fluid may enter the throat, causing a mild stinging sensation. These effects typically improve over time with proper training.
Concentration-related risks:
Hypotonic solutions (lower salt concentration) may cause burning sensations, nausea, coughing, and other discomforts.
Hypertonic solutions (higher salt concentration) may impair mucociliary clearance, leading to pain, irritation, and nasal obstruction.
Long-term risks: Anosmia (loss of smell) may occur as a temporary or permanent adverse event following Jal-Neti practice.
Hygiene-related risks: Any hygiene-related concern may cause microbial infection.
Considering the critical biomedical factors, mentioned above the standardisation of the Jal-Neti process is essential to ensure its safe and effective practice.
Prior Art Patent References: A novel composition for isotonic nasal irrigation has been patented (US20130156871A1), featuring a pH level below 7.0. This formulation comprises a salt, a pH buffer, and optional additives, which collectively facilitate the treatment of nasal and sinus disorders, including dryness, rhinitis, and sinusitis. Moreover, this composition effectively removes various contaminants, such as mucus, pollen, allergens, viruses, and bacteria, from the nasal cavity. The composition can be presented in either liquid or dry form.
A patented nasal spray solution (US8337906B2) has been developed to hydrate the nasal passages and alleviate dryness. This formulation consists of a hypotonic saline solution, a buffering agent, a lubricating agent, and an antimicrobial agent. The synergistic combination of these components provides effective hydration and protection to the nasal mucosa, while also preventing microbial growth.
In light of the foregoing, there is a need for the Crystalline salt composition for enhanced jal-neti experience that overcomes problems prevalent in the prior art.
OBJECTS OF THE INVENTION:
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
The principal object of the present invention is to overcome the disadvantages of the prior art by providing the Crystalline salt composition for enhanced jal-neti experience.
An object of the present invention is to provide the crystalline salt composition for enhanced jal-neti experience that simplifies this process with the water-soluble crystalline salt composition that homogeneously dissolves in water and forms the perfect solution for Jal-Neti.
Another object of the present invention is to provide the Crystalline salt composition for enhanced jal-neti experience that is carefully formulated to match the optimum pH suitable for human physiology so it would be helpful to avoid irritation or any other discomfort caused by osmotic imbalance, it also includes a clinically permitted anti-microbial agent that would be used to disinfect the Jal-Neti solution.
Another object of the present invention is to provide the Crystalline salt composition for enhanced jal-neti experience that are packed in pre-measured sachets, ensuring convenience and accuracy in preparing 250 mL water solution to perform Jal-Neti.
Another object of the present invention is to provide the crystalline salt composition for enhanced jal-neti experience that makes nasal cleansing more convenient, safe, therapeutic, and ideal for those seeking to maintain nasal health, reduce congestion, or practice yoga traditions with ease.
Another object of the present invention is to provide the crystalline salt composition for enhanced jal-neti experience that involves flushing nasal passages with a saline solution to clear mucus, dust, and impurities. This improves breathing and reduces allergies. However, preparing the saline solution can be tricky, leading to irritation or infections if not done adequately. Using an ideal w/v ratio of salt and clean, contamination-free water is important to perform safer Jal-Neti for all.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY OF THE INVENTION:
The present invention provides a crystalline salt composition for enhanced jal-neti experience that is designed to standardise and optimise Jal-Neti, a yoga-based nasal irrigation technique. This invention addresses the vibrant issues associated with nasal irrigation, including:
Variable Solution Concentration: Inconsistent salt concentrations can lead to irritation, discomfort or infection.
Water Quality Concerns: Usage of contaminated water may introduce harmful microorganisms, exacerbating respiratory issues.
pH Imbalance: Solutions with pH levels deviating from the natural nasal mucosa pH (5.5-6.5) can cause discomfort, irritation, or damage to the nasal passages.
Key Features:
Pre-Measured Crystals: Fast-dissolving crystals in pre-measured sachets ensure consistent and accurate preparation of the saline water as a homogeneous solution.
Antimicrobial Properties: The crystals comprise ingredients that exhibit antimicrobial properties, reducing the microbial load in the water.
pH Balance: The formulation ensures a pH range according to physiological requirements appropriate for the nasal mucosa, preventing irritation or discomfort.
This invention provides a standardised, quantified and pH-balanced solution, effectively addressing the pertinent issues associated with the Jal-Neti practice. Consequently, this innovation supports an optimised nasal irrigation process, catering to the needs of yoga practitioners and individuals seeking an enhanced nasal irrigation experience, alleviating related discomforts and complications.

BRIEF DESCRIPTION OF DRAWINGS:
Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
No Figure
DETAILED DESCRIPTION OF DRAWINGS:
While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and the detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim.
As used throughout this description, the word "may" is used in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles, and the like are included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention.
In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element, or group of elements with transitional phrases “consisting of”, “consisting”, “selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, several materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
The present invention provides Crystalline salt composition for enhanced jal-neti experience. The invention consists of the following main components:
Neti Kshar Mix: Neti-Kshar is a precisely formulated crystalline composition that integrates three key components. (1) The primary component is homogeneous crystals of Sodium Chloride (NaCl), which is the main constituent of this product. The amount of salt will be sufficient to make 0.9% w/v with the osmolarity of 286 mOsm/L solution with water (2.25 grams for 250 mL). Neti Kshar ensures that the salt provided meets the national or international purity standards, with a moisture content of less than 1% and free from contaminants such as heavy metals and bacteria. (2) A crystalline antimicrobial agent (Povidone-Iodine) that will be 0.5% in the final solution of 250 mL, providing broad-spectrum coverage against bacteria and viruses (This ingredient is confined only in the mustard yellow colour sachets); and (3) a buffering agent, maintaining an optimal pH range (5.5-6.5) to create a gentle and safer environment for the nasal mucosa. The Neti-Kshar crystals will be provided in pre-measured, one-time-use, moisture-free sachets. This will ensure unique consistency and ease of use for every practitioner. Each sachet is designed to be mixed with 250 mL of water to prepare an accurate Neti solution.
Unit Sachets: Two types of unit sachets will be provided in a pack (i) Sachets having pistachio green colour (HEX: #93C572) and (ii) Sachets having mustard yellow colour (HEX: #FFDB58). Both unit sachets are being used to keep the Neti Kshar ingredients as a single-use module. A sachet has been designed with the measurements of 5x3x2 cm (LxWxH) and it is made up of food-grade paper. Individual sachets will be sealed through heat or appropriate glue. In a complete pack six (06) mustard yellow colour sachets and twenty-four (24) pistachio green colour sachets.
Outer Packing: The outer packing is designed as a larger box, made from an environmentally sustainable and bio-degradable box with the internal wrap of food-grade materials and sealed through appropriate glue. Each outer packing box will contain a total of thirty (30) units (24 + 6) of both colour-coded Neti Kshar sachets.
Process of Preparation and Usage: Preparation of Neti Kshar Solution for Jal-Neti - Take a sachet of “Neti-Kshar” and pour the complete amount into a clean and empty Neti-pot then add 250 mL of clean lukewarm drinking water to it. Allow or stir a bit to dissolve it completely. Now the solution is ready to perform Jal-Neti.
To Perform Jal-Neti Kriya: For this, the person/practitioner should sit comfortably in a forward-leaning position (Kagasana). The procedure involves inserting the nozzle of a prefilled neti-pot into one nostril, allowing the lukewarm Neti Kshar saline solution to flow through the nasal passage and exit through the other nostril. Normal breathing should continue through the mouth throughout the procedure. Repeat the process with the other nostril as well. The 250 mL solution is sufficient to perform the Neti kriya from both nostrils.
After completing the process, it is recommended to practice Kapalbhati (a breathing technique involving forceful exhalation followed by passive inhalation, to expel any residual irrigating fluid).
Recommendation: It is recommended that Jal-Neti practices using Neti Kshar be performed with the pistachio green sachets for six days, followed by the mustard yellow sachets on the seventh day. During any course of nasal infection, If mustard yellow sachets are available, it is advised to use them for Jal-Neti.
Ingredients and their Functions: Neti-Kshar is a precisely formulated crystalline composition that integrates three key components:
Crystalline Sodium Chloride: The primary component of the Neti Kshar mix is homogeneous crystals of Sodium Chloride (NaCl), which are formulated with a precise uniformity of characteristics. This ensures the consistency of crystalline salt in terms of its composition, structure and properties throughout its entire volume.
Antimicrobial agent: Neti-Kshar composition used Povidone-Iodine (PVP-I) which would provide 0.8% final concentration in 250 mL to use in Jal-Neti kriya. This is a time-tested antimicrobial agent that can be used for broad-spectrum coverage against upper nasopharyngeal localisation of bacteria and viruses. Previous research revealed that using PVP-I at a concentration of 0.23% did not significantly impact quality-of-life parameters in individuals who had recently been vaccinated against SARS-COV-II or were experiencing mild COVID-19 symptoms. A separate study conducted by Gluck et al. examined the effects of liposomal PVP-I dispersion on nasal function, finding that its application to the nasal mucosa did not impair nasal function or damage the multilayer ciliated epithelium of the nose. Instead, it improved nasal function parameters, suggesting enhanced mucociliary clearance, likely due to humidification, increased surfactant levels, and/or the mucolytic activity of iodide. These findings indicate that 0.6% PVP-I Oro-Nasal spray is safe for long-term use. Studies have consistently shown that concentrations of PVP-I below 2.5% do not adversely affect the ciliary frequency or cause any pathological changes in the ciliated nasal epithelium, upper respiratory tract, or mucosal cells. Oral administration of PVP-I has not been associated with adverse events in either conscious adults or children (Alsaleh et al., 2024; Anderson et al., 2020; Bidra et al., 2020; Eggers et al., 2018). Moreover, allergic reactions and contact sensitivity to PVP-I are extremely rare. Long-term mucosal use of PVP-I at concentrations up to 5% has also not been linked to clinical thyroid disease (Frank et al., 2020a, 2020b). Notably, povidone-iodine at a concentration of 0.5% has demonstrated rapid efficacy against SARS-CoV-2, achieving a greater than 3log10 reduction in viral load within 15 seconds of contact, as measured by the 50% cell culture infectious dose (Frank et al., 2020b). Considering these findings we have used only 0.5% PVI-I as an important ingredient.
Buffering Agent: Neti Kshar contains a unique combination of salt, buffer components, and an antimicrobial agent. The buffer components play a crucial role in maintaining the optimal pH range (5.5-6.5), thereby creating a gentle and safer environment for the nasal mucosa. This optimal pH range helps prevent irritation, discomfort, and potential damage to the upper respiratory tract, which may arise from physiological alterations.
This invention offers several advantages over existing practices for performing Jal-Neti (nasal cleansing) practices. These advantages address prevalent issues inherent in traditional methods, thereby enhancing the overall user experience and efficacy of the procedure. The key benefits of this invention are as follows:
Pre-measured Sachets: Conventional Jal-Neti protocols necessitate manual admixture of salt and water, with quantities being user-defined and thus prone to inconsistency. In contrast, this invention provides pre-measured sachets, facilitating the preparation of optimal solutions for Jal-Neti. This ensures a comfortable and effective cleanse, eliminating the need for additional preparation.
Antimicrobial Properties: Traditional Jal-Neti protocols often fail to address the risk of microbial contamination, thereby predisposing practitioners to upper respiratory tract infections caused by bacteria, viruses, and other microorganisms. In contrast, the Neti Kshar composition incorporates clinically approved antimicrobial agents at optimum concentrations, ensuring an infection-free nasal cleansing experience.
pH Balance: Optimal pH levels are crucial for a comfortable and effective Neti experience. However, tap water often fails to meet these requirements, potentially leading to irritation and discomfort. The Neti-Kshar formulation addresses this issue by incorporating a buffering agent that maintains an optimal pH for the nasal passage, thereby ensuring a gentle and irritation-free experience for practitioners.
Ease of Use: This invention simplifies the preparation of Jal-Neti solutions, eliminating the need for manual measurement and mixing. The pre-measured sachets ensure consistency and convenience, making the overall process hassle-free.
Hygiene and Safety: The Neti Kshar sachets prioritise user hygiene and safety by minimising the risk of contamination. This innovative packaging ensures that the formulation remains sterile and effective, providing practitioners with a reliable and trustworthy solution for nasal cleansing.
The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.
, Claims:A crystalline salt composition for nasal irrigation, comprising:
Sodium Chloride (NaCl) in a concentration sufficient to form a 0.9% w/v isotonic solution with an osmolarity of 286 mOsm/L when dissolved in 250 mL of water;
Povidone-Iodine as an antimicrobial agent, present in an amount to achieve a 0.5% concentration in the final solution, providing broad-spectrum antimicrobial coverage; and
a buffering agent to maintain the solution’s pH in the range of 5.5 to 6.5, creating a gentle environment for the nasal mucosa;
wherein the composition is provided in pre-measured, single-use, moisture-free sachets for ease of preparation and use.
The composition as claimed in Claim 1, wherein the Sodium Chloride comprises moisture content of less than 1%, and is free from contaminants such as heavy metals and bacteria.
The composition as claimed in Claim 1, wherein the sachets are colour-coded as:
Pistachio green sachets containing only Sodium Chloride and buffering agent; and
Mustard yellow sachets containing Sodium Chloride, buffering agent, and Povidone-Iodine, with a distinctive antimicrobial property.
The composition as claimed in Claim 1, wherein the sachets are designed with dimensions of 5×3×2 cm and made of food-grade paper, sealed through heat or suitable glue to maintain sterility and efficacy.
A method for preparing a nasal irrigation solution using the crystalline salt composition of Claim 1, comprising:
mixing the contents of a sachet with 250 mL of clean, lukewarm drinking water in a Neti pot; and
stirring until the composition is completely dissolved.