Butea monosperma

Butea monosperma

1. Identity: Botanical Classification, Names, and Natural Source

Butea monosperma (Lam.) Taub. is the accepted scientific name for this species. It is an Indian traditional medicinal tree known by the common names "flame of forest," "palash," "bastard teak," and "dhak." The family Fabaceae comprises 630 genera and 18,000 species distributed throughout Asian countries. A widely used botanical synonym is Butea frondosa Roxb., along with synonyms including Butea braamania DC. and Butea frondosa Willd.

The plant is commonly known as palash, dhak, flame of the forest, bastard teak, bijasneha, khakara, chichara, and Bengal kino. In traditional Sanskrit texts it is referred to as Palasha, Kinshuka, and Brahmavriksha, among other synonyms.

1.1 Botanical Description and Distribution

Butea monosperma is a tree of tropical and subtropical climate found throughout the drier parts of India, often gregarious in forests, open grasslands, and wastelands. It grows on a wide variety of soils including shallow, gravelly sites, black cotton soil, clay loams, and even saline or waterlogged soils. It is an erect, medium-sized tree of 12–15 m high, with a crooked trunk and irregular branches.

Butea monosperma is native to tropical and subtropical parts of South Asia and Southeast Asia. The plant grows across Bangladesh, India, Nepal, Pakistan, Sri Lanka, Myanmar, Thailand, Laos, Cambodia, Vietnam, Malaysia, and western Indonesia.

The bark produces a crimson exudate that, when dried, hardens into a substance called "Butea gum" or "Bengal kino." The gum is considered valuable by druggists because of its astringent qualities and by leather workers because of its tannin.

1.2 Plant Parts Used and Common Preparations

Almost all the parts of the plant — root, leaves, fruit, stem bark, flowers, gum, and young branches — are used as medicine, food, fibre, and for other miscellaneous purposes such as fish poison, dye, fodder, utensils, etc.

The major medicinal preparations and forms documented in the literature include:

• Flowers: Flowers are rich in flavonoids, triterpene, butein, butin, isobutrin, coreopsin, isocoreopsin, and sulphurein. Flowers are prepared as aqueous decoctions, ethanolic extracts, and traditionally as a summer beverage (sharbat).
• Bark: Bark contains gallic acid, palasitrin, butrin, butolic acid, cyanidin, lupenone, and palasimide. Bark is used as decoctions, powder, and ethanolic/ethyl acetate extracts.
• Seeds: Seed powder is known for its notable medicinal, pharmaceutical, and insecticidal activities. Seeds are commonly used as powders and methanolic extracts.
• Gum (Bengal kino / kamarkas): Kamarkas gum, also known as Butea gum or Bengal kino, is a natural exudate obtained from Butea monosperma, traditionally valued for its medicinal and nutritional properties in India and other regions. Gum contains tannins, pyrocatechin, and mucilaginous materials.
• Leaves: Leaves of butea are rich in glucoside, linoleic acid, oleic acid, and lignoceric acid.
• Seed oil (kino-tree oil / moodooga oil): A fixed yellow oil expressed from seeds and used topically and medicinally.

2. Traditional and Historical Use

2.1 Ancient Textual References

It has been a cornerstone in traditional medicine practices for centuries, with references found in ancient mythological and medical texts such as the Upanishads, Vedas, Sushruta Samhita, and Charaka Samhita. Palash is described in Charaka Samhita, Sushruta Samhita, Upanishads, Vedas, Astanga Sangraha, and Astanga Hridaya. It is traditionally used since the Vedic era for different therapeutic purposes in various parts of India.

Acharya Charaka and Sushruta used flowers and bark of this tree to prepare various medicines. In Ayurveda it is used as anthelmintic and tonic.

2.2 Ayurvedic, Siddha, and Unani Traditions

The plant is used in Ayurvedic, Unani, and Siddha medicine for various ailments. The Ayurvedic formulations made from this plant are used to reduce the vāta and kapha among the tridoṣas.

This plant is used ethnobotanically in Ayurveda, Unani, Homeopathic, and Allopathic systems of medicine as an astringent, aphrodisiac, antifertility agent, analgesic, for burning sensation, diuretics, diarrhea, dysentery, depurative, filariasis, gout, helminthiasis, leprosy, night blindness, piles, skin diseases, sore throat, snake bite, tumours, ulcer, etc.

The plant is traditionally reported to possess astringent, bitter, alterative, aphrodisiac, anthelmintic, antibacterial, and anti-asthmatic properties.

2.3 Specific Traditional Preparations and Purposes

Butea monosperma is one of the traditional Ayurvedic medicinal plants considered a rich source of ingredients used in home remedies to treat various diseases, such as diarrhea, constipation, hypertension, dehydration, bronchial asthma, leucorrhea, cancer, infection, as well as liver and stomach disorders.

In Ayurvedic pharmacology, the plant's different parts were considered to possess different energetic qualities: Ayurveda explains it as a drug possessing Ushna veerya (hot in potency) in the bark and root, and Sheeta veerya (cold in potency) in the flowers and leaves. It is used in Kapha-Vataja disorders.

This herb is bitter, pungent, and astringent in taste and used to stimulate digestive fire. It has hot potency and is used as an aphrodisiac and laxative. It is used for treating bone fractures, ulcers, abdominal tumors, vata-related disorders, piles, worm infestation, and anal disorders.

Many Ayurvedic medicines such as Krimikuthar rasa, Mahanarayana taila, Janma ghutti, and Palasabeejadi Churna contain Palash as an ingredient.

The gum was also used non-medicinally: the flowers are among the traditional sources of natural dye used since ages for dyeing fabric, and the plant is part of various rituals and celebrations, particularly during the Hindu festival of Holi, where its flowers are used to create natural dyes. About 45 medicinal uses are associated with the plant, and of these claims, almost half the number have been scientifically studied and reported.

3. Key Chemical Constituents and Active Compounds

The presence of flavonoids, triterpenes, steroids, chalcones, and fatty acids in different parts of B. monosperma, including the stem, root, leaves, and flowers, makes it a versatile ingredient in various therapeutic applications. A number of constituents belonging to imides, lactones, flavonoids, sterols, and alkaloids has been reported from various species of Butea.

3.1 Flower Constituents

The flowers are the most extensively studied part chemically. Several phenolic compounds, especially flavonoids, have been identified in flowers of B. monosperma, including gallic acid, butein, butin, isobutrin, coreopsin, isocoreopsin (butin 7-glucoside), sulphurein, monospermoside (butein 3′-β-D-glucoside), isomonospermoside, chalcones, and aurones.

• Butrin (flavanone glycoside): Butrin is a flavanone glycoside that is butin substituted by two beta-D-glucopyranosyl residues at positions 7 and 3′, respectively. It has a role as an anti-inflammatory agent and a plant metabolite. It has a molecular formula of C₂₇H₃₂O₁₅ and molecular weight of 596.5 g/mol.
• Butein (chalcone/isoflavone): Butein is a flavonoid with a molecular formula of C₁₅H₁₂O₅ and molecular weight of 272.25 g/mol. Butein, one of the most studied compounds in Butea monosperma, has been shown to possess anti-cancer, anti-diabetic, and anti-inflammatory activities. Butein inhibits various enzymes, such as tyrosinase and xanthine oxidase.
• Isobutrin: Isobutrin is a structural isomer of butrin, also found in the flowers, contributing to the plant's anti-inflammatory and analgesic properties.
• Coreopsin and isocoreopsin: Coreopsin, another important flavonoid glycoside present in the flowers, exhibits antimicrobial and hepatoprotective effects.

3.2 Stem Bark Constituents

Phytochemical investigation from the stem bark of Butea monosperma led to the isolation and identification of three new compounds named buteaspermin A, buteaspermin B, and buteaspermanol, along with 19 known compounds.

Besides stigmasterol, stigmasterol-β-D-glucopyranoside, and nonacosanoic acid, two new compounds isolated from the stems of Butea monosperma have been characterised as 3α-hydroxyeuph-25-ene and 2,14-dihydroxy-11,12-dimethyl-8-oxo-octadec-11-enylcyclohexane by spectral data and chemical studies.

Previous phytochemical examination indicated the presence of various constituents including cajanin and isoformononetin, stigmasterol, butin, two known flavonoids isobutrin and butrin, free sugars and free amino acids, and (–)-medicarpin, isolated from stem-bark extract, bark, seeds, flower, and petroleum ether and ethyl acetate extracts of stem bark.

The stem is the source of (–)-medicarpin, an isoflavone that imparts anti-fungal properties to the plant.

3.3 Seed Constituents

The presence of triterpenes, flavonoids, butein, butin, stigmasterol, β-carotene, β-sitosterol, myristic, palmitic, stearic, oleic, and linolenic acids, and glucoside in the plant provide it a vast pharmacological potential.

3.4 Gum Constituents

The gum obtained from the tree is rich in gallic acid and tannic acid and is referred to as Bengal kino gum or simply Butea gum.

3.5 Leaf Constituents

UHPLC-QTOF-MS/MS analysis indicated the presence of notable metabolites of significant medicinal potential including apigenin, apigenin C-hexoside C-pentoside, apigenin C-hexoside C-hexoside, apigenin-6,8-di-C-pentoside, and genistin in B. monosperma leaf extract.

4. Mechanisms of Action

4.1 Anti-inflammatory Mechanisms

The most thoroughly characterised molecular mechanism for B. monosperma is NF-κB inhibition. The aim of a key study was to examine whether a standardized extract of B. monosperma flower (BME) could inhibit inflammatory reactions in human mast cells (HMC) using activated HMC-1 cells as a model. Four previously characterised polyphenols — butrin, isobutrin, isocoreopsin, and butein — were isolated from BME by preparative thin layer chromatography, and their purity and molecular weights were determined by liquid chromatography/mass spectrometry analysis.

Butrin, isobutrin, and butein significantly reduced the phorbol 12-myristate 13-acetate and calcium ionophore A23187-induced inflammatory gene expression and production of TNF-α, IL-6, and IL-8 in HMC-1 cells by inhibiting the activation of NF-κB. In vitro kinase activity assay revealed that isobutrin was a potent inhibitor of IκB kinase complex activity. This was the first report identifying the molecular basis of the reported anti-inflammatory effects of BME and its constituents butrin, isobutrin, and butein.

In addition, isobutrin was most potent in suppressing the NF-κB p65 activation by inhibiting IκBα degradation, whereas butrin and butein were relatively less effective.

Hydroethanolic extract of B. monosperma flowers, butrin, and isobutrin displayed significant anti-inflammatory properties in normal human keratinocytes, involved in skin inflammation, by decreasing proinflammatory cytokines IL-8, IL-1β, and IL-6.

4.2 Antidiabetic Mechanisms

A study clearly negated the possibility of antidiabetic activity by inhibited gastrointestinal enzyme action or by reduced glucose absorption. Reduction of fasting and postprandial glucose level was reconfirmed (P < 0.05). Improved serum lipid profile via reduced LDL, cholesterol, triglycerides, and increased HDL was also established (P < 0.05). Significant insulin secretagogue activity of B. monosperma was found in serum insulin assay of B. monosperma-treated type 2 diabetic rats (P < 0.01).

The antioxidant activity, α-glucosidase, and α-amylase inhibition properties of freeze-drying-assisted ultrasonicated leaf extracts (hydro-ethanolic) of B. monosperma have been investigated. The findings revealed that the 60% ethanolic fraction exhibited high phenolic contents, total flavonoid contents, highest antioxidant activity, and promising α-glucosidase and α-amylase inhibitions.

4.3 Osteogenic and Osteoprotective Mechanisms

Isolated compounds from stem bark were evaluated using neonatal rat calvaria-derived primary osteoblast cultures. Five of the compounds showed promising osteogenic activity, attributed to increased osteoblast proliferation, differentiation, and mineralisation as evidenced by marked increase in expression of alkaline phosphatase (an early phase differentiation marker), and alizarin Red S and von Kossa silver staining.

Analysis of phytoestrogens revealed significant enrichment of cladrin, isoformononetin, and medicarpin in the acetone-soluble fraction (ASF) over the total extract (BTE). The ASF at a 10-fold lower dose than BTE was effective in preventing ovariectomy-induced bone loss and stimulated new-bone formation.

4.4 Anticancer Mechanisms

Butein has been extensively studied for its anti-cancer properties. It induces apoptosis in various cancer cell lines, inhibits angiogenesis, and suppresses metastasis. The anti-cancer mechanism involves the modulation of multiple signalling pathways, including the inhibition of NF-κB and the activation of the p53 pathway.

4.5 Hepatoprotective Mechanisms

B. monosperma bark extract (Beac) considerably inhibited thioacetamide-induced expression of p-PI3K, p-Akt, and p-mTOR in hepatocytes as revealed from immunohistochemical studies. This finding was the first evidence of inhibitory action of B. monosperma bark on these pro-carcinogenic proteins. HRMS analysis revealed the presence of quercetin, buteaspermin B, and ononin in the Beac fraction of Butea monosperma.

5. Scientific Evidence by Area of Use

5.1 Anti-inflammatory Activity

Evidence level: In vitro and animal studies; no confirmed human clinical trials.

The most important in vitro study to date used human mast cells (HMC-1). The aim of the study was to examine whether a standardized extract of BM flower could inhibit inflammatory reactions in human mast cells using the activated HMC-1 cell model. Four polyphenols — butrin, isobutrin, isocoreopsin, and butein — were isolated by preparative thin layer chromatography. Butrin, isobutrin, and butein significantly reduced induced inflammatory gene expression and production of TNF-α, IL-6, and IL-8 in HMC-1 cells by inhibiting the activation of NF-κB.

In animal models, a study investigated the anti-inflammatory effects of Butea monosperma on an induced inflammatory model by evaluating pro-inflammatory biomarkers and their computational analysis. The anti-inflammatory activity may be attributed to phytoconstituents for inhibitory effects on IL-8 and TNF-α. Rats (n = 48) were equally divided into groups of 8, with doses of 50, 100, 200, and 400 mg/kg. TNF-α and IL-8 were tested by serum ELISA.

Methanolic extracts from Butea revealed anti-inflammatory properties against carrageenan-induced paw oedema and cotton pellet granuloma in albino rats. Ethanolic extract of bark from Butea showed significant anti-inflammatory activities compared to indomethacin as a standard drug.

5.2 Antidiabetic / Antihyperglycaemic Activity

Evidence level: Animal studies and in vitro; no adequate randomised controlled human trials identified.

Multiple animal studies support hypoglycaemic potential. Oral administration of the ethanolic extract of Butea monosperma seeds (300 mg/kg body weight) exhibited significant antidiabetic, hypolipidaemic, and antiperoxidative effects in non-insulin-dependent diabetes mellitus rats.

To evaluate chronic effects, type 2 diabetic rats were given extract at 250, 500, and 1000 mg/kg doses by gavage, twice daily for 48 days. This was further ascertained by a study on insulin secretion on isolated rat islets (P < 0.05). Improved sensitivity of glucose was shown by the significant increase in hepatic glycogen deposition (P < 0.05).

Oral administration of B. monosperma leaf and bark extracts (500 mg/kg) significantly decreased (P ≤ 0.05) blood glucose compared to initial levels; the total reduction in fasting blood glucose concentration brought about by the leaf and bark extracts was 28 and 11%, respectively.

Aqueous flower extract of B. monosperma showed potential antidiabetic activity on yeast cells. In vivo studies showed strong anti-oxidative and antidiabetic activities by lowering blood glucose levels and increasing insulin secretion.

Traditionally the leaves of B. monosperma in Pakistan are used to treat diabetes mellitus, but very limited scientific evidence is present in this context. All evidence to date is preclinical; no verified, adequately powered human clinical trials have been reported.

5.3 Hepatoprotective Activity

Evidence level: Animal studies and in vitro; no human trials identified.

A study dealt with the evaluation of hepatoprotective properties of the ethyl acetate fraction (Beac) from B. monosperma bark in a rat model. In preliminary antioxidant studies, Beac demonstrated pronounced superoxide scavenging (IC₅₀ 88.85 μg/ml) and anti-lipid peroxidation (IC₅₀ 131.66 μg/ml) potential. In animal studies, Beac showed protective effect against thioacetamide-induced pathophysiology in the liver of male Wistar rats.

The pre-treatment of rats with Beac at 50, 100, and 200 mg/kg body weight was able to normalise biochemical markers including SOD, CAT, GSH, and GR.

It can be concluded that B. monosperma bark is a rich source of phytochemicals with in vitro and in vivo protective activities which deserves further mechanistic studies for its use as a hepatoprotective agent in the prevention of hepatic inflammation and its related malignancies.

Butea monosperma flower extract also has hepatoprotective activities. Butrin is known for hepatoprotective and cytoprotective effects.

5.4 Chemopreventive / Anticancer Activity

Evidence level: Animal studies and in vitro; no human clinical trials identified.

Chemopreventive effects of Butea monosperma extract were documented on hepatic carcinogenesis and on tumour promoter-induced markers and oxidative stress in male Wistar rats. Treatment of male Wistar rats for five consecutive days with 2-AAF i.p. induced significant hepatic toxicity, oxidative stress, and hyperproliferation. Pre-treatment with B. monosperma extract (100 and 200 mg/kg body weight) prevented oxidative stress by restoring the levels of antioxidant enzymes and also prevented toxicity at both doses. The promotion parameters induced by 2-AAF were also significantly suppressed dose-dependently by B. monosperma.

The leaves of B. monosperma possess antioxidant and anticancer activity, which is a prerequisite for anticlastogenic activity. A study evaluated the effect of Butea monosperma leaf extracts on cyclophosphamide-induced clastogenicity and oxidative stress in mice, assessing the role of aqueous and ethanolic leaf extracts on cyclophosphamide-induced oxidative stress and DNA damage using micronucleus assay for anticlastogenic activity and biochemical estimation of malondialdehyde and glutathione for antioxidant activity.

5.5 Anthelmintic Activity

Evidence level: In vitro and animal studies; one older clinical observation recorded.

Methanolic extracts of seed showed significant anthelmintic activities. Seeds have anthelmintic property especially for roundworms and tapeworms.

A clinical investigation of the plant in worm infestation revealed its efficiency in cases of roundworm and threadworm infestations; the medicine was shown to be ineffective in other types. This represents a very limited historical clinical report, and modern controlled trials are absent.

5.6 Osteoprotective Activity

Evidence level: Animal studies and in vitro; no human trials identified.

In a uterotrophic assay, the total bark extract (BTE) was mildly estrogenic in adult ovariectomised rats. In immature rats, BTE exhibited both estrogenicity and antiestrogenicity. The acetone-soluble fraction (ASF) had neither uterine estrogenicity nor antiestrogenicity.

The ASF has been reported to induce new bone formation and prevent ovariectomy-induced bone loss at a dose of 100 mg/kg. Skeletal responses by the treatment and its abandonment were evaluated by BMD, trabecular microarchitecture, biomechanical strength, and bone metabolic markers. Being a phytoestrogen, the bone-conserving effects of ASF upon treatment withdrawal in ovariectomised rats were compared with ovariectomised animals administered with 17-beta estradiol at a pharmacological dose comparable to that recommended for estrogen replacement therapy.

5.7 Antifertility / Reproductive Effects

Evidence level: Animal studies only; no human trials; relevant to safety considerations.

Butin isolated from the seeds of Butea monosperma and administered orally to adult female rats at doses of 5, 10, and 20 mg/rat from day 1 to day 5 of pregnancy showed anti-implantation activity in 40%, 70%, and 90% of the treated animals, respectively. At lower doses, there was a dose-dependent termination of pregnancy and reduction in the number of implantation sites. In ovariectomised young female rats, butin exhibited estrogenic activity at comparable anticonceptive doses but was devoid of anti-estrogenic activity. Butin is a weak estrogen, in that a significant uterotrophic effect was discerned even at 1/20th the anticonceptive dose.

A study on male reproductive toxicity reported that a 40% decline in fertility rate was evident in rats administered with 500 mg/kg of B. monosperma. In groups administered Butea monosperma flower extracts, most of the damage in testis occurred at the 90th and 180th days of administration.

5.8 Wound Healing

Evidence level: In vitro and animal studies; in silico modelling; no human trials.

Plant-derived compounds from Butea monosperma, well known for its medicinal properties, contain several phytochemical compounds that contribute to wound healing. These compounds include flavonoids, tannins, and triterpenoids, which exhibit anti-inflammatory, antimicrobial, and antioxidant activities.

Based on in silico analysis, the phytochemicals in B. monosperma possess significant potential for use in wound-healing applications. These findings required additional in vitro and in vivo studies to confirm the effectiveness and safety of these drugs for improving wound healing.

5.9 Antimicrobial and Antifungal Activity

Evidence level: In vitro only.

Flower and leaf extracts showed antifungal activity against Candida albicans, Saccharomyces cerevisiae, and Fusarium solani.

5.10 Antithrombotic Activity

Evidence level: One human study reported; details limited in sources.

Methanolic extracts of leaves from Butea showed anti-thrombosis activities in humans. This is a brief and isolated reference in the literature; the study design, sample size, and endpoint details are not fully characterised in the available sources reviewed.

5.11 Nephroprotective Activity

Evidence level: Animal studies only.

The stem bark of Butea isolate showed a potential source of natural hepatoprotective and nephroprotective properties that can be ascribed to the antioxidant potential of B. monosperma.

6. Body Systems and Health Areas of Association

Based on the peer-reviewed pharmacological literature, Butea monosperma is primarily associated with the following body systems and health domains:

• Musculoskeletal system: Osteogenic and osteoprotective activity via phytoestrogen-like and non-estrogenic mechanisms; potential application in post-menopausal bone loss (animal data only).
• Metabolic / Endocrine system: Antidiabetic effects via insulin secretagogue activity, improved hepatic glycogen deposition, α-glucosidase and α-amylase inhibition, and improved lipid profiles (animal data).
• Immune / Inflammatory system: NF-κB suppression and inhibition of TNF-α, IL-6, and IL-8 in human mast cells (in vitro); anti-inflammatory action in animal models.
• Gastrointestinal system: Anthelmintic activity against intestinal parasites; astringent properties for diarrhoea.
• Hepatic system: Hepatoprotective activity through antioxidant mechanisms and inhibition of pro-carcinogenic signalling proteins.
• Reproductive system: Documented phytoestrogenic effects; antifertility potential (animal studies) — relevant both as a potential therapeutic target and as a safety concern.
• Integumentary system: Wound-healing potential via anti-inflammatory and antimicrobial phytochemicals.
• Oncological: Chemopreventive potential through NF-κB, p53, antioxidant, and apoptotic mechanisms (preclinical only).

7. Dosages Reported in Studies

The following dosages appear explicitly in peer-reviewed sources. These are exclusively laboratory and animal-model doses unless otherwise indicated; no standardised human dose has been established in regulatory-grade clinical trials.

• Oral administration of the ethanolic extract of Butea monosperma seeds at 300 mg/kg body weight was used in a non-insulin-dependent diabetes mellitus rat study exhibiting antidiabetic, hypolipidaemic, and antiperoxidative effects.
• Type 2 diabetic rats were given extract at 250, 500, and 1000 mg/kg doses by gavage, twice daily for 48 days, to evaluate chronic antidiabetic effects.
• Leaf and bark aqueous extracts at 500 mg/kg were administered in a streptozotocin-induced diabetes rat study.
• In an anti-inflammatory rat study, doses of 50, 100, 200, and 400 mg/kg were tested; rats (n = 48) were divided into 8 per dose group.
• Pretreatment with B. monosperma extract at 100 and 200 mg/kg body weight was used in a chemopreventive rat study targeting hepatic carcinogenesis.
• Pre-treatment of rats with the bark ethyl acetate fraction (Beac) at 50, 100, and 200 mg/kg body weight was used in a hepatoprotective study.
• 100 mg/kg of the acetone-soluble fraction (ASF) of stem bark was used in an ovariectomised rat osteoporosis model for bone-formation assessment.
• In a chronic toxicity study, seed powder suspension was orally given to rats at a dose of 800 mg/kg/day for 90 days.
• Butin isolated from seeds was administered orally to adult female rats at doses of 5, 10, and 20 mg/rat from day 1 to day 5 of pregnancy in an anti-implantation study.
• A 40% decline in fertility rate was observed in male rats administered 500 mg/kg of B. monosperma.

8. Safety Considerations

8.1 Acute Toxicity

Butea monosperma extract was safe at limit doses of 4,000 and 2,000 mg/kg in acute oral toxicity testing, with no mortality in studied subjects.

Mice were administered the aqueous flower extract up to 6,000 and 4,000 mg/kg for acute oral and intraperitoneal toxicity, respectively, while up to 4,500 mg/kg for sub-acute oral toxicity (30 days). The toxicity studies ascertained the safety of an aqueous extract of B. monosperma flower up to 6,000 mg/kg on oral administration.

8.2 Chronic Toxicity

A dedicated 90-day chronic toxicity study in rats identified several organ-level changes at a high dose. Seed powder suspension was orally given to rats at 800 mg/kg/day for 90 days. Parameters studied included body weight, organ weight, biochemical and haematological parameters, bone marrow cytology, and histopathology of vital organs. Test drug administration did not affect body weight, organ weight, and bone marrow cytology to a significant extent. Among 18 haematological parameters studied, significant changes were observed in three: significant decrease in haemoglobin content, red blood cell count, and haematocrit. Of 16 biochemical parameters studied, significant changes were observed in 5: decrease in total protein, albumin, bilirubin, and significant increase in VLDL and triglycerides.

Histopathology of 18 organs revealed changes such as fatty changes, glomerular congestion and tubular haemorrhage in the kidneys, decrease in the cellularity of the spleen, epithelial disruption in jejunum, decrease in spermatogenesis in the testis, and epithelial proliferation in ventral prostate.

8.3 Phytoestrogenic and Antifertility Safety Concerns

The seed constituent butin possesses documented reproductive effects in animals. Butin isolated from the seeds of Butea monosperma and administered orally to adult female rats at doses of 5, 10, and 20 mg/rat from day 1 to day 5 of pregnancy showed anti-implantation activity in 40%, 70%, and 90% of the treated animals, respectively. At lower doses, there was a dose-dependent termination of pregnancy and reduction in the number of implantation sites. In ovariectomised young female rats, butin exhibited estrogenic activity at comparable anticonceptive doses but was devoid of anti-estrogenic activity.

In the uterotrophic assay, the total bark extract (BTE) was mildly estrogenic in adult ovariectomised rats. In immature rats, BTE exhibited both estrogenicity and antiestrogenicity. These findings indicate that preparations containing significant amounts of butin or the total bark extract may exert hormonal effects and carry reproductive risks, particularly in pregnancy, based on animal data.

8.4 Potential Adverse Effects Noted in Traditional Sources

Fixed oil in the seed and glucoside butrin of the flower sap are considered to be poisonous. Consumption may cause dizziness, headache, and hypotension.

8.5 Overall Evidence Quality and Gaps

The vast majority of pharmacological evidence for Butea monosperma derives from in vitro cell culture studies and animal models (primarily rodents). The report identifying the molecular basis of anti-inflammatory effects of BME and its constituents butrin, isobutrin, and butein noted novel pharmacological actions of these polyphenolic compounds, indicating potential therapeutic value for the treatment of inflammatory and other diseases in which activated mast cells play a role. Human randomised controlled trials are largely absent from the published literature. The findings from in silico and in vitro studies require additional in vitro and in vivo studies to confirm the effectiveness and safety of these compounds for therapeutic use. The chronic oral toxicity study in rats at high doses identified haematological, biochemical, and histopathological changes that warrant caution and underscore the need for formal human safety and toxicology data.

References

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• Effect of Butea monosperma leaf extracts on cyclophosphamide induced clastogenicity and oxidative stress in mice. PMC4285655
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• Total extract and standardized fraction from the stem bark of Butea monosperma have osteoprotective action. PubMed PMID 20395887
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