Kalyanaka Ghrita (KG) is a polyherbal-medicated Ghrita that is in practice since Vedic times in the traditional system of Indian medicine. Recently, KG was enlisted under the National List of Essential Ayush Medicines, published by the Ministry of Ayush, Government of India, January 2022. Hence, the question always strikes the mind to perceive the historical evolution of KG from the Vedic period to recent times. An extensive literature survey was conducted to search the references of KG in the available Ayurvedic databases to analyze the difference in their herbal ingredients, dose, and therapeutic indications. Total 16 formulations were identified under the name of KG in authoritative textbooks of Ayurveda, with surprisingly similar herbal ingredients and numerous therapeutic indications.

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The herb Gojihva is enumerated in Ayurveda as a Shaaka (vegetable) and is also a medicine in the management of various diseases. The official source of Gojihva is as per Ayurvedic Pharmacopeia of India is Onosma bracteatum Wall. However, at present many botanical sources, Caccinia glauca Savi., Trichodesma indicum R.Br., Elephantopus scaber L., Launaea species., and Launaea nudicaulis (L.) Hook. f. (L. N) are also considered as botanical sources of Gojihva by many scholars. Gojihva is mentioned in major Ayurveda classics but a comprehensive data regarding its synonyms, properties, and uses are not framed in a systematic manner. Further, there are no published contemporary reviews for its one of the source plants Launaea nudicaulis L. (Hook.) f. Thus, a comprehensive review of Gojihva is done from various Ayurveda classics. The relevant information about L.N is collected from research articles published in various journals, floras, and books. The review revealed that various synonyms (Darvipatri, Godhumika, Kharpatri) indicating morphology of plant are given to Gojihva in Nighantus. The pharmacodynamics attributes are Tikta rasa (bitter taste), Laghu guna (light), Sheeta veerya (cold potency), Katu vipaka (pungent biotransformation), and Kaphapittaghna (pacifies Kapha and Pittadosha). It is indicated for external and internal administration for various diseases such as Raktapitta (bleeding disorder), Kushta (skin diseases), Prameha (diabetes mellitus), and Vrana (wound). L.N is reported for anti-diabetic, antioxidant, and anti-microbial potential. The review suggests that L.N is not evaluated on scientific parameters for most of the classical Ayurveda indications. Therefore, the present article may provide the scope for the rational evaluation of L.N on various classical Ayurveda indications.

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BACKGROUND: Lekhaniya Mahakashaya (LM) is indicated in Ayurveda for obesity. Its classical dosage form is Kashaya (decoction), which involves time-consuming preparation and has a low shelf-life. The aim of the study was, therefore, to modify the dosage form of LM into a dispersible tablet (DT), a unit solid dosage form close to decoction, due to its conversion into aqueous solution during administration. METHODS: Raw materials were authenticated as per API standards. To develop and optimize the DT, totally six trials for each of the 30 tablets were carried out by direct compression method using two super disintegrants, viz., Sodium Starch Glycolate (SSG) and Croscarmellose Sodium, with the effervescent agents, tartaric acid, and sodium bicarbohydrate. The developed formulation was analyzed for its pre- and post-compression parameters besides Fourier transform infrared (FTIR). RESULTS: The formulation made using Anhydrous Lactose (AL) as a binding agent and SSG as a super disintegrant passed all the quality parameters of a DT. The average weight was 500 mg. The angle of repose was 0.600, Carr’s index was 19.40, and Hausner’s ratio was 1.24. Disintegration time was 2.5 min, friability was less than 1%, hardness was 2.5, and weight variation was less than 5%. FTIR revealed the presence of functional groups such as phenolics, alcohol, alkene, and nitride. CONCLUSION: LM can be modified into a DT using AL as a binding agent and SSG as a super disintegrant. Further studies are warranted to fix the clinical dose and assess efficacy.

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BACKGROUND: Standardization and validation for Ayurvedic polyherbal preparation using modern techniques of analysis are extremely important. Sanjivani Vati (SV) is one such a multicomponent formulation, which is well known for its multiple uses. Even so, it lacks the latest scientific measures to ensure its safety and efficacy more precisely. So, an attempt has been made to standardize the pharmaceutical procedure of SV and to validate its analytical profile. To develop Standard Manufacturing Procedure (SMP) of SV and to validate its quality control parameters. METHODS: Five batches of SV were prepared in the pharmaceutical laboratory, All India Institute of Ayurveda, New Delhi, India, following a classical reference. They were further subjected to an organoleptic, relevant physicochemical and physical, heavy metal, and microbial limit analysis along with a chromatographic as well as spectroscopic evaluation, that is, Fourier transform infrared spectroscopy (FTIR) and gas chromatography-mass spectrum (GCMS). RESULTS: A batch size of 100 g of SV can be prepared by using 10 g of its each ingredient, 250 mL of cow’s urine required for levigation of 6 h 45 min with a yield of around 730 pills of average weight 130.64 ± 2.43 mg, and after drying for 5 h 52 min at 50°C. These findings accomplished the chief objective of its pharmaceutical standardization. Analytical specifications of SV are highly amorphous powder, mild bitter in taste with odor of cow’s urine and having brownish black color. All the physicochemical parameters were found validated as per official standards except total ash value. Moreover, FTIR showed the presence of hydroxy, alkane, amide, acyl, alkoxy, and aromatic compounds. Fingerprinting assay revealed seven and nine retardation factor values at 254 and 366 nm, respectively. Furthermore, a total of 21 compounds were detected in GCMS. Pills were also observed free from specific heavy metals, microbes, and pesticides indicating good manufacturing practices. CONCLUSION: This is a preliminary report generating results for standardization as well as validation of SV that could be used for future references. Moreover, further works should be carried out to explore the therapeutic outcomes of this medication.

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BACKGROUND: Amrita Bhallataka Rasayana (ABR) is one such Ayurvedic polyherbal compound formulation containing Bhallataka as an integral component. It is mainly indicated for rejuvenating purpose. An interesting fact in the preparation of ABR is the quantity of sugar that is to be added as per our convenience and the form of finished product (Avaleha or Ghrita). Earlier research scholars have kept this formulation as Ghrita (medicated ghee) or Avaleha (medicated semisolid preparation) dosage form as the amount of Ghrita is more in this formulation but Paka is to be done as per Avaleha dosage form. Hence, it becomes difficult to prepare and standardize such formulations. To validate the standard manufacturing process (SMP) and quality standards of Amrita Bhallataka Rasayana. METHODS: A total of three batches of ABR were prepared and subjected to organoleptic, physicochemical, high-performance thin-layer chromatography (HPTLC), and nutritional analysis to generate an analytical profile of ABR. In phytochemical qualitative analysis, the presence of saponins, flavonoids, and tannins was assessed by using appropriate qualitative testing methods. RESULTS: Using pertinent physicochemical criteria in accordance with the Ayurvedic Pharmacopeia of India, an analysis of raw and Shodhita Bhallataka was conducted. The alkaline pH value of ABR may be observed due to protein-tannins complexes between milk and oil of Bhallataka. HPTLC was done to develop a chromatographic pattern of three samples of ABR. The average water-soluble extractive of ABR was 54.14%, whereas alcohol-soluble extractive was 19.93%. CONCLUSION: The method of preparation given in the current study for ABR may be considered standard. These preliminary parameters may be helpful as standards for further studies as they are not mentioned in the Ayurvedic Pharmacopeia of India. This study may provide certain leads toward using different proportions of sugar in the preparation of ABR.

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BACKGROUND: Libirite capsule (LC) is a polyherbal formulation, developed to treat erectile dysfunction and loss of libido. Present study aimed to perform the acute oral toxicity studies of LC in Swiss Albino mice and Sprague Dawley rats, and repeated dose subchronic 90-day toxicity study were performed to assess the safety of LC. METHODS: LC was orally administered at 2000 mg/kg to the animals as per Organization for Economic Cooperation and Development (OECD)-423 guidelines. In a repeated dose oral toxicity study, LC was administered through oral gavage in a dose of 250, 500, and 1000 mg/kg for 90 days and compared with control groups as per OECD-408 guidelines. Posttreatment changes in food consumption, body weight, and biochemical, hematological, and laboratory parameters were observed. RESULTS: LC did not produce any adverse or mortality events in animals during acute studies. In a 90-day toxicity study, rats exhibited no toxicity symptoms or death. No significant changes were found in hematological and biochemical parameters. No significant alteration was seen in organ and body weight. Microscopic findings were incidental and identical for control and treated animals at 1000 mg/kg. LC did not produce any histopathological changes in target organs. No change in the recovery group was observed when compared with the control group animals, which indicated a complete reversal. CONCLUSIONS: Median lethal dose₅₀ of LC was observed to be more than 2000 mg/kg. No observed adverse effect level of LC was considered 1000 mg/kg.

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BACKGROUND: Kantakari Avaleha (KA) is a semisolid herbal drugs preparation recommended for various diseases like Hikka (hiccup), Kasa (cough), Shvasha (dyspnoea/asthma), and Shoola (colicky pain) in Sharangdhara Samhita. In this study, KA was slightly modified (after an experiment of classical and intermediate batches) by adding sugar and honey 1.5 and 2 times, respectively, in comparison to the classical method, to overcome its palatability issues in the pediatric age group. It is important to standardize the modified drug to make the drug formulation reproducible. Hence, the present study was aimed to evaluate pharmacognostical and pharmaceutical parameters of the modified Kantakari Avaleha (MKA) prepared for pediatric use. METHODS: Preauthenticated raw drugs were procured from pharmacy, ITRA, Jamnagar, Gujarat, India, and two pilot batches and final modified KA were prepared at RSBK Department, ITRA, Jamnagar. Samples from all three Avaleha were evaluated for organoleptic parameters and microbial study; samples from MKA were evaluated for pharmacognocy, physicochemical parameters, and high-performance thin-layer chromatography. RESULTS: Taste of MKA was improved compared to classical and intermediate formulations. Stability in terms of microbial overgrowth remains the same as the classical one. All the other evaluated parameters were comparable with Ayurveda Pharmacopeia of India standards except total, reducing and nonreducing sugar content. CONCLUSION: MKA was found to be palatable for pediatric use. The pharmacognostical and physico-chemical evaluation of final formulation revealed that this modified formulation meets almost all the pharmacopeial parameters (except sugar content) and hence data of the current study could be used as pharmaceutical standards for this specific MKA. Clinical study will be needed to determine whether the change in the proportion of sugar and honey has a favorable or negative impact on the clinical outcome.

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BACKGROUND: In Ayurveda, medicinal plants have been organized into various categories based on several parameters. One such classification is based on actions, wherein the therapeutic agents have been categorized into 50 groups. Among these, Hridyadashemani is one that includes the fruits of Amra, Amrataka, Lakucha, Karamarda, Vrukshamla, Amlavetasa, Kuvala, Badara, Dadima, and Matulunga. The objective of this study was to identify and develop preliminary analytical standards for the ten herbs of Hridyadashemani. METHODS: The herbs were collected from their natural habitat and subjected to macroscopic and microscopic evaluation as per standard procedures. The analytical study that includes foreign matter (%w/w), total ash (%w/w), acid insoluble ash (%w/w), alcohol-soluble extractive (%w/w), and water-soluble extractive (% w/w) of the herbs were conducted as per standard pharmacopeial guidelines. Preliminary phytochemical evaluation and high-performance liquid chromatography (HPLC) analysis of the herbs for the presence of quercetin and gallic acid were carried out. RESULTS: The macroscopic and microscopic features of the fresh and dried fruits were documented and compared to published literature. The analytical standards were recorded and compared to pharmacopeial standards and published literature. The herbs were found to contain various quantities of quercetin and gallic acid. These phytochemicals may have a potential role in cardiovascular diseases. CONCLUSION: The preliminary analytical findings include HPLC finger print profile which would serve as a monograph for Hridyadashemani. Further studies may be taken up to analyze the use of these herbs in various cardiovascular diseases.

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BACKGROUND: Sida veronicifolia Lam. (Malvaceae), popularly known as Nagabala, is a well-known medicinal plant of the Indian system of medicine, traditionally used in a variety of health problems. In spite of the significant pharmacological activities of S. veronicifolia roots, no detailed botanical and chemical work is reported. In the present study, the authors aimed to develop the pharmacognostical and chemical standards using instrumental analytical techniques. METHODS: Sophisticated analytical techniques viz. TLC-densitometry, high-performance liquid chromatography, and Fourier-transform infrared spectroscopy were utilized in the present study. RESULT: The pharmacognostic parameters, physicochemical parameters, and chemical profiling have provided valuable information as a tool of identification of the plant. CONCLUSION: The quality standards developed in this study can serve not only for authentication of S. veronicifolia roots but also discrimination from other roots of Sida genus.

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BACKGROUND: Hypertension is the most common treatable risk factor for cardiovascular disease. Hypertension is a multifactorial clinical condition and thus can be managed in multiple pathways. Management of hypertension with modern antihypertensive medication is not ideally effective due to side effects and adverse effects associated with their long-term use. Thus, a novel Ayurvedic formulation NIA/DG/2015/01 test drug (TD) was designed to address multiple pathway management of hypertension. Further, albeit the simultaneous use of modern and Ayurveda antihypertensive is common, there is no systematic study to evaluate the combined effect and adverse effect of this simultaneous use. This study is aimed to evaluate the antihypertensive activity of a novel Ayurvedic formulation (TD) both as an adjuvant with modern antihypertensive drugs and as a stand-alone drug in fructose-induced hypertensive albino rats. METHODS: TD comprises of the combination of aqueous extract of root of Boerhavia diffusa L., whole plant of Convolvulus prostratus Forssk., rhizome of Nardostachys jatamansi (D. Don) DC., bark of Terminalia arjuna (Roxb. ex DC.) Wight & Arn., and root of Withania somnifera (L.) Dunal. TD was administered 90 mg/kg body weight, P.O. twice a day for 28 days to evaluate its effect in fructose-induced hypertensive rats using the Quinapril as a standard drug. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured on day 7^th, 14^th, 21^st, and 28^th day of drug administration by noninvasive BP system for rodents. RESULTS: TD significantly reduced SBP and DBP in comparison to the standard drug Quinapril. (P < 0.001, one-way analysis of variance followed by Turkey’s multiple comparison test and Dunnett’s multiple comparison test). CONCLUSION: Ayurvedic formulation possesses significant antihypertensive activity in fructose-induced hypertensive albino rat model.

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