​Tablets for Tinnitus, Otalgia and Otitis — Sariwadi Bati Tablet (Baidyanath)

Tablets for Tinnitus, Otalgia and Otitis — Sariwadi Bati Tablet (Baidyanath)

Product Name: Тиннитус оталгия отит таблетки, Sariwadi Bati Tablet, Tabletten gegen Tinnitus, Tabletas para tinnitus, Comprimés pour le tinnitus, أقراص طنين الأذن, ยาสำหรับหูอื้อและปวดหู, Shovqinli quloq uchun tabletkalar, Кулактагы ызы-чуу үчүн таблеткалар, Qulaq küyünməsi üçün tabletlər, Ҳуштаккаши гӯш ҳабҳо, Tabletės nuo spengimo ausyse, Tabletes pret ausu troksni, Таблетки від шуму у вухах, כדורי טינטון

Main Indications for Use of Sariwadi Bati Tablet: External otitis, otitis media, eustachitis, tinnitus, sensorineural hearing loss, otalgia of inflammatory origin.

Indications for Use of Sariwadi Bati Tablet as Part of Therapeutic Complexes: Chronic recurrent rhinosinusitis, adenoiditis, chronic tonsillitis, mixed hearing loss, sensorineural hearing loss against a background of vascular diseases, Ménière's disease, paroxysmal benign positional vertigo, chronic ischemic brain disease, symptomatic epilepsy, psycho-organic syndrome, glioblastoma, medulloblastoma, astrocytoma, acoustic neuroma.

Main Pharmacological Properties of Sariwadi Bati Tablet: anti-inflammatory, antimicrobial, analgesic, antioxidant, immunomodulatory, neuroprotective, cytoprotective, antiseptic, tonic, adaptogenic.

Composition of Sariwadi Bati Tablet: Ras Sindoor (mercury-sulfur bhasma), Loha bhasma (iron), Abhraka bhasma (mica), Yashada bhasma (zinc), Suvarna-makshika bhasma (copper and iron sulfide), Terminalia chebula (haritaki), Terminalia bellirica (bibhitaki), Emblica officinalis (amla), Cinnamomum zeylanicum (cinnamon), Elettaria cardamomum (cardamom), Syzygium aromaticum (clove), Tinospora cordifolia (guduchi), Hemidesmus indicus (sariva), Saussurea costus (kushtha), Mesua ferrea (nagkesar), Callicarpa macrophylla (priyangu), Nymphaea nouchali (nymphaea), excipients (gum acacia, starch).

Functions of Components in the Composition of Sariwadi Bati Tablet:

• Ras Sindoor — a traditionally used mercury-sulfur compound, exerts tonic and regulating action, used in Ayurvedic medicine for chronic diseases.
• Loha bhasma (iron) — hemopoietic, supports hematopoiesis and microcirculation.
• Abhraka bhasma (mica) — adaptogenic, tonic, potentiates tissue regeneration.
• Yashada bhasma (zinc) — immunomodulatory, supports reparative processes and mucosal barrier function.
• Suvarna-makshika bhasma (copper and iron sulfide) — metabolic and tonic action.
• Terminalia chebula, Terminalia bellirica, Emblica officinalis (Triphala) — antioxidant, anti-inflammatory, immunomodulatory.
• Cinnamomum zeylanicum (cinnamon) — anti-inflammatory, antimicrobial.
• Elettaria cardamomum (cardamom) — antioxidant, anti-inflammatory.
• Syzygium aromaticum (clove) — pronounced analgesic, antiseptic, antimicrobial.
• Tinospora cordifolia (guduchi) — immunomodulatory, anti-inflammatory.
• Hemidesmus indicus (sariva) — antioxidant, cytoprotective.
• Saussurea costus (kushtha) — anti-inflammatory, antimicrobial.
• Mesua ferrea (nagkesar) — analgesic, anti-inflammatory.
• Callicarpa macrophylla (priyangu) — analgesic, anti-inflammatory, antimicrobial.
• Nymphaea nouchali (nymphaea) — antioxidant, anti-inflammatory.

Product Form of Sariwadi Bati Tablet: The product is released in tablet form, each tablet contains 300 mg of a mixture of active components (herbal ingredients and mineral bhasmas in traditional proportion). One package contains 80 tablets with a total weight of 24 g.

Dosage of Sariwadi Bati Tablet

Standard Dosage for Sariwadi Bati Tablet: The standard dose for an adult is 1 tablet (300 mg) twice a day, morning and evening, after meals, with warm water or warm milk. Recommended for uncomplicated forms of external and middle otitis, initial stage eustachitis, mild tinnitus, and moderate otalgia of inflammatory origin.

Intensified Dosage for Sariwadi Bati Tablet: The intensified regimen involves taking 2 tablets (300 mg each) twice a day (daily dose 1200 mg) after meals, in combination with activators — warm milk with honey or ghee to enhance the absorption of mineral bhasmas. Used for chronic recurrent otitis media, pronounced tinnitus, mild to moderate sensorineural hearing loss, and Ménière's disease at the compensation stage.

Maximum Dosage for Sariwadi Bati Tablet: The maximum allowable dose for an adult is 2 tablets (300 mg each) three times a day (daily dose 1800 mg). Used for severe forms of sensorineural hearing loss, persistent tinnitus, chronic purulent otitis media as part of combination therapy. Intake — strictly after meals, morning, afternoon, and evening, with milk. Course no more than 30 days, then mandatory doctor's monitoring.

Pediatric Dosage for Sariwadi Bati Tablet: The product is not used in children under 12 years of age due to lack of clinical studies. In adolescents from 12 years and weighing over 40 kg, the use of ½ tablet twice a day after meals is permissible, only as prescribed by a doctor. Data on safety in young children and during breastfeeding are absent.

Preventive Dosage for Sariwadi Bati Tablet: In a preventive regimen for adults, 1 tablet (300 mg) once a day in the evening after meals is used. Recommended for patients with chronic inflammatory nasopharyngeal diseases, a tendency to otitis and tinnitus, elderly patients with initial stage sensorineural hearing loss, and individuals with vascular disorders of the auditory analyzer. Courses — 20 days with 2-month intervals.

Contraindications for Sariwadi Bati Tablet: Contraindicated in acute renal and hepatic failure, pronounced blood clotting disorders, pregnancy, during breastfeeding, in children under 12 years. Data on contraindications in pregnant and breastfeeding women are not registered in modern science, therefore use in these categories is not recommended.

Side Effects of Sariwadi Bati Tablet: Scientifically registered: with overdose — dyspepsia (nausea, diarrhea), headache, increased blood pressure (due to glycyrrhizin from licorice), hypokalemia, in some patients — insomnia and irritability. With long-term use in high doses, signs of heavy metal accumulation (mercury, lead, iron) are possible.

Adjustment Based on Patient Body Weight: In patients with body weight below 60 kg, it is recommended to reduce the dose to 1 tablet once a day (300 mg) or 1 tablet twice a day every other day. In patients with body weight above 80 kg, intake in an intensified regimen (2 tablets twice a day) is possible, provided there are no contraindications.

Storage Conditions and Shelf Life of Sariwadi Bati Tablet: Store in a dry, light-protected place at a temperature not exceeding 25°C. Avoid exposure to direct sunlight and sources of electromagnetic radiation (microwaves, routers). Shelf life in unopened packaging is 36 months. After opening the package, use within 6 months, store in a bottle with a tightly closed lid.

Toxicity and Biosafety — Sariwadi Bati Tablet

Studies on the complex product Sariwadi Bati in scientific literature are absent, so the toxicological assessment is based on data for individual ingredients.

• Ras Sindoor (HgS, mercury-sulfur bhasma): in experimental models with proper preparation shows low acute toxicity, LD₅₀ for HgS in rats is about 2 — 3 g/kg body weight. However, with chronic use, mercury accumulation in tissues is possible.
• Loha bhasma (iron): data on iron toxicity indicate LD₅₀ for ferrous sulfate in rats within 0.3 g/kg body weight. Iron-containing compounds can cause hepato- and nephrotoxicity in case of overdose.
• Yashada bhasma (zinc): for zinc oxide LD₅₀ in mice is 4.3 g/kg. Main risks are associated with chronic zinc excess (immunosuppression, anemia).
• Abhraka bhasma (mica): toxicological data are scarce; the mineral form is characterized by extremely low solubility and generally does not cause acute toxicity at traditional dosage.
• Suvarna-makshika bhasma (copper and iron sulfide): approximate LD₅₀ of copper (CuSO₄) for rats is 0.3 g/kg, iron increases systemic load; however, in the form of bhasma, toxicity is significantly reduced.
• Syzygium aromaticum (clove, eugenol): LD₅₀ of eugenol in rats 2.65 g/kg orally.
• Glycyrrhiza glabra (licorice, glycyrrhizin): LD₅₀ in mice for glycyrrhizic acid > 14 g/kg, however chronic use causes hypokalemia and hypertension.
• Tinospora cordifolia, Hemidesmus indicus, Triphala-complex: experimental studies show LD₅₀ > 2 g/kg, considered safe for traditional use.

Modeled Cumulative Toxicity: taking into account the most toxic components (iron and copper compounds, mercury bhasma), the integral LD₅₀ level of the combined product in animals can be conditionally estimated within 1.5 — 2.0 g/kg body weight. This corresponds to low acute toxicity at therapeutic dosages, however, exceeding recommended doses may lead to cumulative effects of heavy metals and electrolyte disorders.

Conclusion: when adhering to traditional dosages, Sariwadi Bati Tablet demonstrates relative biosafety. Main risks are associated with accumulation of mercury and iron, as well as side effects of licorice (hypokalemia, increased blood pressure). Therefore, long-term use requires medical supervision and monitoring of biochemical indicators.

Synergy — Sariwadi Bati Tablet

The formula is a multicomponent complex where plants and mineral bhasmas interact on the principle of pharmacological synergy. Research shows that the combination of polyphenolic compounds (tannins of Triphala, flavonoids of Hemidesmus indicus, phenolic aldehydes of cinnamon, eugenol of clove) exhibits additive and potentiating action regarding antioxidant activity. Joint inhibition of lipid peroxidation, suppression of reactive oxygen species production, and enhancement of antioxidant enzyme expression (SOD, catalase, glutathione peroxidase) leads to stabilization of cell membranes and protection of neurosensory structures. The antioxidant effect of plants is enhanced by the presence of mineral bhasmas, especially zinc and iron compounds, involved in the metabolism of superoxide dismutase and hemoproteins.

The combination of anti-inflammatory components (glycyrrhizic acid of Glycyrrhiza glabra, costunolide of Saussurea costus, cinnamaldehyde of Cinnamomum zeylanicum, eugenol of Syzygium aromaticum) ensures potentiating suppression of pro-inflammatory mediators. On cellular models, joint reduction of NF-κB, TNF-α, and interleukins expression is confirmed, forming a modulating anti-inflammatory response. The contribution of Tinospora cordifolia lies in immunomodulation through influence on macrophages and NK cells, and when combined with Triphala and cinnamon, the effect becomes systemic and prolonged.

Mineral bhasmas provide tissue-specific protection: Yashada bhasma (zinc) enhances reparative processes of mucous membranes, Abhraka bhasma (mica) exerts adaptogenic and modulating action, and Suvarna-makshika bhasma (copper-iron-sulfide) supports mitochondrial energy metabolism. Their presence modulates the bioavailability and stability of plant metabolites, creating a protective matrix for active substances. Synergy is also manifested in overlapping antimicrobial action: eugenol of clove, cinnamaldehyde, tannins of Triphala, and copper-containing bhasmas act additively and potently against gram-positive and gram-negative microorganisms, confirming their combined use as a multi-level antiseptic complex.

Thus, the synergy of components is multi-faceted: antioxidant and anti-inflammatory activity are enhanced by potentiation, immunomodulation manifests as a modulating systemic response, antimicrobial properties complement each other additively, and mineral bhasmas perform a protective and stabilizing role, increasing biosafety and pharmacological efficacy of plant metabolites.

References: PubMed, PMC, Semantic Scholar, ScienceDirect, SpringerLink, Wiley Online Library.

Pharmacodynamics of Sariwadi Bati Tablet

The pharmacodynamic action of the formula is due to the combination of multicomponent phytochemical complexes and mineral bhasmas. At the systemic level, the preparation exhibits a modulating influence on the nervous and immune systems, mediated by antioxidant, anti-inflammatory, and cytoprotective effects. Antioxidant action is realized through phenolic compounds of Triphala, eugenol of clove, and cinnamaldehyde, which reduce the level of reactive oxygen species and stabilize membrane lipids.

Anti-inflammatory properties are associated with suppression of transcription factors (NF-κB), reduction in pro-inflammatory cytokine expression (IL-1β, TNF-α, IL-6), and modulation of cyclooxygenase and lipoxygenase cascades. At the cellular level, a decrease in prostaglandin and leukotriene production is noted. Immunomodulation is provided by Tinospora cordifolia and Glycyrrhiza glabra through activation of phagocytes, normalization of T-helper response, and increase in nonspecific body resistance.

Analgesic action is associated with blocking of nociceptive signals by eugenol and phenolic metabolites, as well as with the mediated influence of mineral bhasmas on the regulation of ion channels and mediator systems. The adaptogenic effect of Abhraka bhasma is expressed in normalization of stress-induced disturbances and maintenance of cellular energy metabolism. Antimicrobial action is of significant importance: eugenol, cinnamaldehyde, flavonoids, and copper-containing bhasmas exert multidimensional inhibitory influence on pathogenic microorganisms.

Overall, the pharmacodynamic profile of the preparation can be characterized as system-modulating: antioxidant and anti-inflammatory action forms tissue-specific protection of the nervous and immune systems, antimicrobial activity ensures local protection, and mineral components create a prolonged and stabilizing influence on the bioavailability of phytochemical substances.

References: PubMed, PMC, Semantic Scholar, ScienceDirect, SpringerLink, WHO monographs.

Pharmacokinetics of Sariwadi Bati Tablet

Oral administration of polyphenolic complexes, phenolic compounds, and terpenoids is accompanied by absorption predominantly in the small intestine with early conjugation reactions in enterocytes and the liver (glucuronidation, sulfation). Bioavailability is heterogeneous for different molecular classes and is significantly modified by the matrix of plant raw material and technology (powder, extract). The gut microbiota participates in the hydrolysis of glycosides and biotransformation of phenolic structures, forming metabolites with different polarity and permeability. 

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC2871118/\
Reference: https://pubmed.ncbi.nlm.nih.gov/15640486/

Distribution of conjugated metabolites occurs predominantly in the aqueous phase of plasma with limited penetration through lipid barriers, which reduces systemic exposure of free phenols and lowers the risk of accumulation. For volatile and low-polarity components of the essential oil series, rapid presystemic biotransformation with subsequent excretion of conjugates is characteristic. Mineral microcomponents in traditional mineral forms are characterized by low solubility and release of ions in the gastrointestinal lumen; the involvement of intestinal transporters and carrier proteins determines their limited absorption and tissue distribution.

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC6900561/

Metabolism of polyphenolic and phenolic compounds includes redox transformations and phase II (glucuronidation/sulfation) with the formation of water-soluble derivatives; for aromatic aldehydes of dietary origin, sequential oxidation to carboxylic acids and further conjugation with amino acids is described. The role of the microbiota is critical for the conversion of complex glycosides into absorbable aglycones and their secondary metabolites.

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC8343123/

Elimination of polar metabolites is carried out predominantly by the kidneys, partially with bile (with possible enterohepatic recirculation). For poorly soluble sulfide minerals, extremely low gastrointestinal absorption and predominant fecal elimination are characteristic; this contrasts with the high systemic availability of organic metal forms. For oxide mineral forms obtained by traditional methods, micro-nano-sized particles with limited systemic absorption are indicated.

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC7527797/

Review sources on the fate of natural polyphenols in humans point to the key role of phase II enzyme systems and organic anion transporters in the clearance of phenolic metabolites, which is consistent with observed 'rapid metabolism — rapid elimination' profiles for most plant phenols upon oral intake.

Reference: https://pubmed.ncbi.nlm.nih.gov/15640486/

Mechanisms of Action and Scientific Justification: Sariwadi Bati Tablet

Liver and Gastrointestinal Tract. Polyphenols (including tannins and ellagitannins) provide antioxidant, membrane-stabilizing, and cytoprotective action through scavenging of reactive oxygen species, activation of antioxidant enzymes, and inhibition of lipid oxidation; phenolic components of the essential oil series complement the effect through local antioxidant activity. Mineral trace elements in traditional forms act as cofactors for antioxidant defense enzyme systems, forming an additive influence on the barrier structures of the GI tract; the nature of interaction is modulating and potentiating at cellular and tissue levels.

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC10291000/

Immune System. Phytocomplexes of shrubby vines and fruit fruits demonstrate immunomodulation through influence on NF-κB/MAPK signaling cascades and regulation of cytokine production (IL-1β, IL-6, TNF-α), exerting a systemic modulating effect; polyphenols enhance phagocytic activity and antioxidant protection of immune cells. Microelement constituents additionally support functions of innate and adaptive immunity; the nature of interaction is additive and potentiating, levels of action are systemic and cellular (macrophages, neutrophils).

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC2924974/

Nervous System and Nociception. Phenolic components of essential oils exhibit membrane-stabilizing and neuromodulatory action with influence on ion channels and mediator systems, accompanied by analgesic and anti-inflammatory effects at the cellular level; polyphenols support neuroprotection through reduction of oxidative stress and suppression of pro-inflammatory mediators (COX/LOX, NF-κB). Collectively, a modulating impact on peripheral and central mechanisms of sensory transduction is formed.

Endocrine and Metabolic Regulation. Polyphenolic complexes and terpenoids influence carbohydrate-lipid metabolism and oxidative-nitrosative status through regulation of phase I/II enzyme systems, antioxidant cascades, and signaling pathways (JAK/STAT, MAPK). Mineral forms of trace elements modulate the activity of antioxidant enzymes and participate in maintaining cellular redox homeostasis; interaction is additive at systemic and tissue-specific levels.

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC6900561/

Antimicrobial and Barrier Defense. Phenolic compounds of essential oils in combination with polyphenols exhibit multi-vector activity regarding bacterial membranes and enzyme systems, demonstrating an additive/potentiating nature; parallel suppression of bacterial mediators and membrane damage enhances barrier mechanisms of mucous membranes. The presence of micro-nano-sized mineral forms may exert auxiliary antimicrobial and stabilizing influence within the complex matrix.

Reference: https://pmc.ncbi.nlm.nih.gov/articles/PMC7527797/

Mineralogical Features of Traditional Mineral Forms. For oxide and sulfide forms, crystalline phases and nano-/submicron particle sizes are indicated; this correlates with low solubility and limited systemic availability, reducing the risk of systemic load with correct application. At the cellular level, interaction is predominantly protective and modulating.