A Critical Review on Balachaturbhadra Churna: an Effective Ayurveda Formulation for the Pediatric Age

International Journal of Interreligious and Intercultural Studies (IJIIS) ISSN: 2654-2706, Volume 2, Number 1, April 2019

A CRITICAL REVIEW ON BALACHATURBHADRA CHURNA: AN EFFECTIVE AYURVEDA FORMULATION FOR THE PEDIATRIC AGE

Abhishek Joshi1*, Shrikrishna Rajagopala2, and Patel Kalpana S.3 1Universitas Hindu Indonesia, Denpasar, Bali, Republic of Indonesia 2Department of Bala Roga, All India Institute of Ayurveda, New Delhi 3Department of Kaumarbhritya, IPGT & RA, Gujarat Ayurved University, Jamnagar, Gujarat *

Abstract

Balachaturbhadra Churna offers a multitude of health bene›ts for which it has become so poapular prescription by Kaumarbhritya practioners of Ayurveda. It is a combination of four drugs Musta, Pippali, Ativisha and Karkatashringi. This combination was ›rst mentioned in Chakradatta and has been in practice since a millennium. Many queries have been raised on the usage of Aconite species of drugs recently, thus doubting the safety and ef›cacy of Balachaturbhadra Churna. Very few works have been published on Balachaturbhadra Churna till now. The aim of the present study was to compile and review such available references from classics and research works published on Balachaturbhadra Churna. Total ›ve studies are published on Balachaturbhadra Churna, which revalidated the impact of classical guidelines. The research papers revealed standards of Quality Control and pharmacological ef›cacy of the drug. All the experimental studies revealed that Balachaturbhadra Churna is having no toxic hazards at very higher Dose levels, proving it safe for therapeutic use. Though certain limitations were observed in these researches, the results can be considered as a lead for further well strati›ed clinical studies.

Keywords: Balachaturbhadra Churna, pharmacology, Quality Control, standards, therapeutic use

Introduction One among them is Balachaturbhadra Very few medicaments have Churna (BCBC) which is a very been described in Ayurveda specially popular and a bene›cial compound indicated for their usage in children. formulation in pediatric usage. It is a

1 A Critical Review on Balachaturbhadra Churna: An Effective Ayurveda Formulation for the Pediatric Age widely practiced formulation that is in combination with other plant species. indicated in respiratory disorders, fever, The clinical effect also varies with diarrhoea and vomiting of children different dosages, forms and modes of (Joshi, et.al., 2013). administration. The nomenclature of Ayurveda was Very few research have been primarily designed to help a physician published on Balachaturbhadra select a plant for medicinal purposes. Churna. Ativisha (Aconitum This is divided into three sub-topics heterophyllum Wall.), one of the named Nama (name), Rupa (form) and ingredients in this combination has Yukti jnana (therapeutic usage), which been questioned by modern research constitutes the three-tier understanding industry for its safety. Aconite species of ausadhi (drug materials) are reported for its cardiotoxic as well (Viswanathan et.al., 2013). Bala means as neurotoxic effects (Chan, 2009) a child, Chatuhu means combination but no studies related to the toxic of four, and Bhadra means which is effect of Aconitum heterophyllum bene›cial or best (Radhakantadeva, Linn. in particular have been reported. 1961). Thus the term Balachaturbhadra Nonetheless the use of this formulation denotes a combination of four drugs that since millennia without reports of any are meant for use in children. The pre›x untoward effect itself is a testimony to Bala suggests that the combination is its safety. Still, an evaluation based on specially indicated in children and is objective controlled experiments and a potent enough to cure the diseases of the standardization of various parameters pediatric age group. will provide proof for the undoubted India has a rich heritage of usefulness of the drug. In this article an traditional herbal medicines. With the attempt has been made to compile and emerging interest of the world to adopt critically evaluate the ancient classics and study traditional systems, many and recent research publication of the opportunities have opened up to take drug Balachaturbhadra Churna. advantage of the potential based on different healthcare systems (WHO, Materials and Methods 2000). The Ayurvedic pharmaceutical Reviews of all references available preparations evolved gradually from a for Balachaturbhadra Churna in simpler form to more complex forms classical texts as well as very recent based on plants and plant mineral literature were explored. Thorough combinations. This is the unique feature searches were carried out on internet of herbal treatments, that one plant sources while articles published species can cure a particular disease and on Balachaturbhadra Churna in also can cure a number of other ailments various journals were analyzed for

2 Abhishek Joshi, Shrikrishna Rajagopala, and Patel Kalpana S. comprehensive understanding of the treatment of various pediatric diseases formulation. like Jvara (fever), Atisara (diarrhoea), Svasa and Kasa (respiratory disorders) Observations and Chardi (vomiting) (Chakradatta, The observations made from the 1976, Sharma and Vijnana, 2001). review are mentioned under various 2. Pharmaceutical standardization headings as follows. Ajazuddin et.al. in 2012 carried 1. Classical references of BCBC out investigations to study the Balachaturbhadra Churna is physicochemical, phytochemical mentioned for the ›rst time in the text and spectrophotometric analysis of Chakradatta (Chakradatta et.al., 1976). formulation (Ajazuddin, 2012). The Later period the same reference is found values of percentage loss on drying, in several text books. The detailed angle of repose, Hausner ratio, Carr’s description of references available is index of the lab formulation were shown in table 1. calculated as 6.84 ± 0.224, 27.36, All the texts have mentioned the 1.25 and 20 respectively. Total ash, same four ingredients. Table 2 shows acid insoluble ash and water soluble the constituents of Balachaturbhadra ash were found 8.148 ± 0.337, Churna. It is a ›ne powder prepared 3.281 ± 0.286, and 45.602 ± 0.414 by mixing equal proportions of Musta respectively. Alcoholic and aqueous (Cyperus rotundus Linn) rhizome, extracts of formulations and ingredients Pippali (Piper longum Linn) fruit, were prepared and evaluated for Ativisha (Aconitum heterophyllum phytochemical analysis and the results Wall.) root and Karkatashringi (Pistacia of extractive values shows higher integerrima Stew.) gall. It is given in the alcoholic extractive value (39.294 ±

Table 1. References available for Balachaturbhadra Churna

Sr. No. Name of text books Reference Time period 1 Cakradatta 64/22 11th century A.D. 2 Gadanigraha 11/93 12th century A.D. 3 Sharangadhar Samhita 6/16 13th century A.D. 4 Bhavaprakasha 71/151 16th century A.D. 5 Yogaratnakara 71/39 17th century A.D. 6 Bhaishajya Ratnaval 71/39 18th century A.D. 7 Bhaishajya Samhita 7/50 20th century A.D. 8 Bharat Bhaishajya Ratnakar 7/24 20th century A.D. 9 Bala Tantra 13/10 20th century A.D. 10 Ayurvedic formulary of India part 1/page 92 20th century A.D.

3 A Critical Review on Balachaturbhadra Churna: An Effective Ayurveda Formulation for the Pediatric Age

Table 2. Constituents of Balachaturbhadra Churna

2.226) of formulation depict that alcohol it had a pleasant odour and bitter taste is a better solvent for extraction. Three for both the formulations. Quantitative laboratory batches of formulation and Analysis of microscopic constituent of Piper longum powder were estimated standard and market formulations of for their piperine content against Balachaturbhadra Churna observed standard piperine solution on double were 3.43 and 3.24 for Starch Grains, beam UV-Visible spectrophotometer at 55.12 and 52.56 for Xylem vessels and max 342.5 nm. it was 170.76 and 176.34 for ›bres Shahebaz et.al. in 2012 made (length). Screening of phytoconstituents an attempt to evaluate and compare in standard and market formulations market formulation with in-house of Balachaturbhadra Churna showed sample of Balchaturbhadra Churna presence of alkaloids, fiavonoids, by performing physico-chemical phenolics, carbohydrates, tannins, screening, phytochemical screening, Sterols and triterpenoids whereas microscopic characterization and coumarins and saponins were absent. fiuorescence analysis (Ghadiyali Estimation of phytoconstituents et.al., 2012). Respective physical in standard and market formulations parameters observed for standard and of Balachaturbhadra Churna were market preparation of Balchaturbhadra respectively 0.107% and 0.096% for Churna were Bulk Density (gm/ Flavonoids, 0.84% and 0.76% for Na+ ml.) 0.5882 and 0.434, Tap Density ion salts, 0.62% and 0.38% for K+ ion (gm/ml) 0.8 and 0.625, Carr‘s Index salts, 2.91 % and 3.74 % for Tannins 26.47 and 30.43, Hausner’s Ratio and for Crude ›bre content it was 1.36 and 1.43 and Angle of Repose 15.5% and 13%. Fluorescence analysis 32.32 and 34.43. Morphological was performed by observing the powder study of Balachaturbhadra Churna of the standard and market formulation showed ›ne consistency for standard of Balachaturbhadra Churna with 1N formulations and very ›ne for market HCL, 1N H2SO4, 1N HNO3, aquous formulations; colour was brown for and alcoholic NaOH, Iodine solution, standard formulations and greyish KOH and NH3 and the fiuorescence in brown for market formulation, while day light and in UV light was compared

4 Abhishek Joshi, Shrikrishna Rajagopala, and Patel Kalpana S. for both the samples. After analysis Qualitative test for various functional it was observed that market samples groups revealed the presence of matched exactly with that of authentic carbohydrates, steroids, cardiac standards of in-house formulation after glycosides, ﬁavanoids, alkaloids and performing the standardization. tannins in the formulations. Saponin Abhishek Joshi et.al. in was absent in Churna. On performing 2013 made an attempt to develop HPTLC, the chromatogram showed 17 Pharmacognostical, Pharmaceutical and peaks with Rf values at 254nm; while HPTLC standards for Balachaturbhadra at 366nm the chromatogram showed Churna. Organoleptic characters 14 spots. Commonly seen Rf values at observed for Balachaturbhadra Churna both 254nm and 366nm were 0.14, 0.18, were light brown colour, spicy pungent 0.23, 0.29, 0.34, 0.35, 0.47, 0.53, and odour, Kashaya - Tikta (astringent – 0.58. bitter) taste and ›ne consistency of the 3. Toxicity study powder. Powder microscopy shows Parmar Parag et.al., in 2011 striking characters of all 4 individual conducted studies on acute toxicity constituents. Starch grains without study on albino rats. Acute toxicity hilum, dark brown colouring matter, study was carried out as per WHO annular vessels and ligni›ed ›bres of guideline for acute toxicity test and Musta, starch grains without hilum, modi›ed as per experimental need stone cells and oil globules form (Anonymous, 1993). The rats were Pippali, simple and compound starch observed closely for behavioural grains, cork cells, prismatic crystals of changes, sign and symptoms of toxicity calcium oxalate and parenchyma cells and mortality continuously for the ›rst from Ativisha, tannin content material, four hours and thereafter periodically fragments of pitted vessels, vascular up to 14 days. Balacaturbhadrika bundles along with tannin cells and Churna did not produce any signs and epidermal cells from Karkatashringi. symptoms of toxicity and mortality up Loss on drying, ash value, to a dosage of 2000 mg/kg in rats. water soluble extract %w/w, alcohol Nariya M. et.al., in 2011 published soluble extracts %w/w, pH value data related toxicological study of of Balachaturbhadra Churna were Balachaturbhadrika Churna. The 4.7%w/w, 5.75%w/w, 29.3%w/w, study was carried out by administering 27.3%w/w and 6 respectively. Particle Balacaturbhadrika Churna in a dose size of Churna was ranging from 60- up to 2000 mg/kg orally once. For 120 mesh. 3.209g, 2.345g, 1.360g, and long-term toxicity, Balacaturbhadrika 3.019g was obtained from >60, 61-85, Churna was administered in doses 86-120 and >120 mesh respectively. of 450 and 900 mg/kg orally for

5 A Critical Review on Balachaturbhadra Churna: An Effective Ayurveda Formulation for the Pediatric Age

45 consecutive days. The effects antibody formation and relative weight of the drug on ponderal changes, of spleen and the thymus of albino rats hematological, biochemical and (Parmar, et.al., 2011). For cell mediated histological parameters were noted. immunity Balacaturbhadrika Churna The acute toxicity experiment at dose of 100 mg/kg and 200 mg/ showed that the drug did not produce kg produced statistically signi›cant any signs and symptoms of toxicity (or changes on comparison with control mortality) up to the dose of 2000 mg/ group at 24 and 48 hours. Thus it can kg. This dose is more than 20 times be inferred that the test drug produces the therapeutic equivalent dose in rats, signi›cant suppression of cell mediated clearly indicating that the formulation immunity. is unlikely to induce any drastic toxic Balacaturbhadrika Churna did not effects. Long-term toxicity results affect antibody formation against Sheep showed that, even at higher dose of 900 RBC at signi›cant level. Examination mg/kg, Balacaturbhadrika churna did of spleen and thymus sections under not affect the parameters studied to a microscope showed increase in features signi›cant extent. of increased cellularity. Though The effect of Balacaturbhadrika increased cellularity of thymus and Churna was studied on bone marrow spleen along with increased proportion cellularity. The test drug did not of white pulp was observed, it does not affect the polychromatic normoblasts, seem to indicate immune stimulation erythrocytes and normoblast showing rather it may be the tissue response to micronuclei at both the dose levels the CMI suppression observed with the studied, in comparison to the control test drug. group. This suggests that it is not likely 5. Clinical studies conducted to assess to have any mutagenicity potential. The its ef›cacy histopathological studies of 16 organs No study has been published till showed that Balacaturbhadrika Churna now to assess the clinical ef›cacy at 450 g/kg increased the cellularity in Balachaturbhadra Churna. the thymus and spleen. Other organs exhibited normal cytoarchitecture Discussion suggesting that the preparation is devoid An overview of the classics of of serious organ degenerative potential Ayurveda throws light into the speci›c at this dose level. features of a child, which make them a 4. Pharmacological study subject for special considerations. The pertaining to its ef›cacy descriptions given in different contexts Parmar Parag et.al. also conducted include Dosha Dushya Malalpata studies on cell mediated immunity, (quantitative and qualitative wise less

6 Abhishek Joshi, Shrikrishna Rajagopala, and Patel Kalpana S.

Dosha, Dushya, Mala), Soukumaryata commentator on Charaka Samhita (delicate by nature), Alpakayata as well as Sushruta Samhita, in text (lower body mass index compared Chakradatta mentioned the combination to adults), Sarvannanupa Sevana Balachaturbhadra Churna for the ›rst (not consuming all types of food), time (Chakradatta et.al, 1976). Later Aparipakwa Dhatu (immature state of to him almost all the renowned texts Dhatus), Asampurna Bala (inadequate of Ayurveda including two from the immunity), Kleshasahishnutwa (unable famous Laghutrayees have described to withstand hardships), Ahara Sankarat Balachaturbhadra Churna in their texts. Aniyatagni (unstable status of Agni as The term Balacaturbhadrika has been not acclimatized with different states used for Balachaturbhadra Churna in of food materials) and Asamatvagata Bhaishajya Ratnavali (Dasa, 1983). Prana Dosha Dhatu Maloujasam There is no controversy regarding (unstable functional and structural the constituents of Balachaturbhadra entities in children) (Samhita, et.al. Churna mentioned in all texts of 2009, Vagbhata et.al., 2005, Agnivesha Ayurveda. The combination of these et.al., 2009, Vridhhajeevaka, et.al. four drugs is unchanged in all these 2009). texts indicating the therapeutic All these postulations give a effectiveness of this particular clear idea about the Dehabala (body combination in pediatric disorders. strength), Agnibala (strength of Total ›ve works related to digestive ›re) and Satwabala (mental Balachaturbhadra Churna which are status) of the pediatric age group. published till now, were compiled in Moreover they provide an idea about this work. the lowered immune status of the child Organoleptic studies reveal ›ne that makes them more susceptible consistency, brownish appearance and for repeated infections. Another aim bitter taste of the Churna (powder). behind these considerations is that All the studies of Churna which were the child cannot tolerate all forms of analysed for Pharmacognosy were medicaments and many of the treatment found having characters of all individual procedures, so these aspects are to be constituents. Striking characters like well considered in the planning and ligni›ed ›bres of Musta, starch grains implementation of treatment protocol. without hilum from Pippali, cork cells, Balachaturbhadra Churna is one such parenchyma cells from Ativisha were formulation mentioned in classics observed in all samples. specially meant for use in pediatric Physical parameters like bulk practice. density, tap density, Carr‘s index, Chakrapani Dutta, the famous Hausner’s ratio and angle of repose

7 A Critical Review on Balachaturbhadra Churna: An Effective Ayurveda Formulation for the Pediatric Age showed better fiow property of signi›cant extent. Immunological Balachaturbhadra Churna. The loss odema represents cell mediated immune on drying of any sample is directly response hence it can be inferred that related to its moisture content. The the Balachaturbhadra Churna produces less value of moisture content could signi›cant suppression of cell mediated prevent bacterial, fungal or yeast growth immunity which is direct correlation of (African pharmacopoeia, 1986). The delayed type hypersensitivity (DTH) values obtained in all studies were response and do not infiuence humoral in accordance to the API standards immune response. The observed effect (Anonymous, 2008). The ash value may be the main mechanism for the indicates the presence of inorganic ef›cacy of the drug in respiratory and salt materials in the sample. The disorders (Parmar, et.al., 2011). The values obtained for all samples of acute and chronic toxicity experiments Balachaturbhadra Churna were as per showed that the drug did not produce API standards except for one study by any signs and symptoms of toxicity Ajazuddin et al. where it was partially even at very high dosages, which clearly higher (Saraf, 2012). This may be due indicates that the formulation is unlikely to various factors involved right from to induce any drastic toxic effect in cultivation of drug till manufacture of spite of containing Aconitum species ›nal product. which is known for cardio-toxic and All the studies show high water- neurotoxic potential. The study on the soluble and alcohol soluble extractive effect of Balachaturbhadra churna on values. This indicates the amount of bone marrow cellularity suggests that it active constituent and the bioavailability is not likely to have any mutagenicity of the plant, in given amount of plant potential (Nariya, et.al., 2011). material when extracted with respective solvents. The pH of Balachaturbhadra Conclusion Churna was found acidic. Phyto- No clinical study has been chemical screening reveals the presence published so far on this classical of carbohydrates, steroids, glycosides, Ayurveda formulation. The doses fiavanoids, alkaloids, phenols and employed for these toxicity studies tannins in the formulations. Saponins is as mentioned in pharmacology study absent in Churna. were several times higher than normal The Balachaturbhadra Churna clinical doses of Balachaturbhadra did not modify humoral antibody Churna, hence the observed changes formation, relative weight of spleen will probably not become apparent and the thymus of albino rats to at therapeutic dose level. This

8 Abhishek Joshi, Shrikrishna Rajagopala, and Patel Kalpana S. undoubtedly solves the safety concerns Balachaturbhadra Churna can be related to the presence of Aconitum considered safe for clinical use.[] species drug in the formulation. Thus

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