Phlomis umbrosa

Other Names

Cao SuCaosuHan Sok-DanHansokdanJerusalem SageMao DongNan fang bian zhongPhlomidis RadixPhlomis maximowicziiPhlomis stenocalyxPhlomis stenocalyx DielsPhlomis umbrosa f. albifloraPhlomis umbrosa f. albiflora Y.N.LeePhlomis umbrosa f. villosaPhlomis umbrosa f. villosa C.Y.WuPhlomis umbrosa Turcz.Phlomis umbrosa var. australisPhlomis umbrosa var. australis Hemsl.Phlomis umbrosa var. emarginataPhlomis umbrosa var. emarginata S.H.Fu & J.H.ZhengPhlomis umbrosa var. latibracteataPhlomis umbrosa var. latibracteata Y.Z.Sun ex C.H.HuPhlomis umbrosa var. ovalifoliaPhlomis umbrosa var. ovalifolia C.Y.WuPhlomis umbrosa var. stenocalyxPhlomis umbrosa var. stenocalyx (Diels) C.Y.WuPhlomis umbrosa var. subaustralisPhlomis umbrosa var. subaustralis K.T.Fu & J.Q.FuPhlomis umbrosa var. sylvaticaPhlomis umbrosa var. sylvatica K.T.Fu & J.Q.FuPhlomis umbrosa var. typicaPhlomis umbrosa var. typica KudôPhlomoides umbrosaPhlomoides umbrosa (Turcz.) Kamelin & Makhm.Phlomoides umbrosa var. australisPhlomoides umbrosa var. australis (Hemsl.) C.L.Xiang & H.PengPhlomoides umbrosa var. latibracteataPhlomoides umbrosa var. latibracteata (Y.Z.Sun ex C.H.Hu) C.L.Xiang & H.PengPhlomoides umbrosa var. ovalifoliaPhlomoides umbrosa var. ovalifolia (C.Y.Wu) C.L.Xiang & H.PengPhlomoides umbrosa var. stenocalyxPhlomoides umbrosa var. stenocalyx (Diels) C.L.Xiang & H.PengShady Jerusalem SageSi-leng-maSok-DanSookdan小兰花烟山芝麻常山白莶糙苏续断

Synopsis

Phlomis umbrosa (Phlomoides umbrosa): A Comprehensive Reference

1. Identity and Botanical Classification

1.1 Accepted Name and Synonymy

Phlomis umbrosa Turcz., belonging to the Lamiaceae family, is a perennial herb native to Korea and northern China. Under a revised taxonomy, its accepted name is Phlomoides umbrosa (Turcz.) Kamelin & Makhm (synonym: Phlomis umbrosa Turcz.), belonging to the family Lamiaceae (= Labiatae). The genus Phlomis / Phlomoides encompasses hundreds of species distributed across Africa, Europe, and Asia, but P. umbrosa is the taxon that has received the most focused scientific attention in East Asian medical research.

The plant is also known as "Caosu" (糙苏) in China and "Han Sok-Dan" in Korea, and it has been used as a traditional medicine for hundreds of years. In the pharmacopeial literature, the dried root is referred to as Phlomidis Radix.

1.2 Distribution and Habitat

P. umbrosa is broadly distributed in China North-Central, China South-Central, China Southeast, Inner Mongolia, Korea, and Manchuria. The plant mainly grows in forests, grassy slopes, thickets, and wet areas.

1.3 Plant Part Used and Common Preparations

P. umbrosa Turczaninow is a perennial herbaceous plant species in the Lamiaceae family. The aerial parts of some species have been used in herbal teas, and the roots of P. umbrosa have been used as a traditional medicine for a long time. This plant is used not only as a traditional medicine to alleviate diseases such as colds, arthritis, and osteoporosis, but also as a food additive. The root is the primary part harvested for medicinal purposes, though young leaves have also been reported in use. Current commercial preparations include standardized aqueous or hydroethanolic root extracts, which appear in both single-herb and multi-herb combinations.

1.4 Misidentification and Adulteration

Both Dipsaci Radix (Dipsacus asper) and Phlomidis Radix (Phlomoides umbrosa) are traditional medicines used in Korea and China for bone-associated diseases; however, the two are misused due to similarities in name and appearance. Dipsacus asperoides and Phlomis umbrosa, two species used in the Korean medicine "Sok-dan," are used for the treatment of bone- and arthritis-related diseases, and they are often mixed or misused. DNA barcoding using ITS2 and matK sequences provides a reliable molecular method for differentiating the species.

2. Traditional and Historical Use

2.1 China: Earliest Records and Classical Texts

In China, P. umbrosa is first mentioned in the Dian Nan Ben Cao (Pharmaceutical Natural History of Southern Yunnan), published in 1436 during the Ming dynasty. P. umbrosa is commonly used as a folk medicine and is listed in the National Compendium of Chinese Herbal Medicine, published in 1975. Phlomis umbrosa is a traditional medicinal plant distributed in the north of China; in the west of Hubei province, its roots were used in the treatment of rheumatic diseases by the Tujia nationality.

This drug has been applied to the treatment of hemorrhage, tinea pedis, common cold, bronchitis, and fractures. In the context of Traditional Chinese Medicine (TCM), the root of Phlomis umbrosa has traditionally been used as a medicine in South Asian nations to treat colds and bone fractures, to staunch bleeding, and as an anti-inflammatory, and such use continues today.

2.2 Korea: The Dong-Eui-Bo-Gam and Han Sok-Dan Tradition

Phlomis umbrosa Turczaninow is a traditional herbal medicine described in the Dong-Eui-Bo-Gam written by Jun Heo in 1613, and is used to treat inflammation, pain, and phlegm. The use of these traditional herbs was described in the Dong-Eui-Bo-Gam, the most famous book on Korean traditional medicine, which is an encyclopedic guideline of medical knowledge and treatment techniques first compiled by Joon Heo in 1613. In Korea, the dried roots of P. umbrosa are well known as "Han Sok-Dan," and the plant has been used for centuries as traditional medicine.

P. umbrosa is used as a traditional herbal medicine to treat inflammation, pain, and phlegm by relieving edema, as described in the Dongui Bogam. Korean herbalists traditionally prepared decoctions from the dried root.

2.3 Summary of Traditional Indications

Preparations of P. umbrosa are considered potential therapeutic drugs to treat bone fractures, rheumatic diseases, and cold; to reduce swelling; and to staunch bleeding in South Asian countries, particularly in Korea, China, and Japan. Phlomis umbrosa Turcz, a perennial herbaceous plant in Asia, has been traditionally used for treatment of bronchitis, colds, bleeding, arthralgia, rheumatic disease, and bone fractures. Traditionally, P. umbrosa has been used for anti-inflammatory, anti-osteoporosis, antiviral, and analgesic effects, and bone growth, among others; new pharmacological effects have also been discovered, such as anti-allergic, antidepressant, antioxidant, and agricultural pest-control activities.

3. Phytochemistry: Key Constituents and Active Compounds

3.1 Overview of Chemical Classes

Phytochemical research reveals that this plant contains triterpenoids, iridoids, phenylethanoids, flavonoids, essential oil, microelements, etc. Many compounds have been isolated and identified from P. umbrosa, including phenylethanoid glycosides, iridoid glycosides, terpenoids, essential oil, and microelements. Chemical constituents are generally categorized into six main groups: iridoid glycosides, phenylethanoid glycosides, triterpenoids, flavonoids, essential oils, and microelements.

3.2 Iridoid Glycosides

Iridoid glycosides are considered among the most pharmacologically significant constituents of P. umbrosa. Biological properties of P. umbrosa are attributed to its diverse phytochemical constituents, including flavonoids, phenolic compounds, iridoids, and phenylethanoid glycosides, such as 8-O-acetyl shanzhiside methyl ester, shanzhiside methyl ester, and sesamoside. Sesamoside, an iridoid glycoside, appeared in higher quantity than shanzhiside methyl ester, umbroside (8-O-acetyl shanzhiside methyl ester), and acteoside.

TLC and HPLC analyses showed that the roots have more iridoid glycosides than the aerial parts. The contents of sesamoside, shanzhiside methyl ester, and 8-O-acetylshanzhiside methyl ester in roots were found to be notably higher than in aerial parts. Phytochemical analysis has identified sesamoside, shanzhiside methyl ester, 8-O-acetyl shanzhiside methyl ester, and isoacteoside as bioactive components; shanzhiside methyl ester has been validated and quantitatively analyzed as a major compound.

3.3 Phenylethanoid Glycosides

Compounds isolated from P. umbrosa include 6″-syringyl-sesamoside, decaffeoylverbascoside, calcelarioside B, verbascoside, isoverbascoside, alyssonoside, sesamoside, shanzhiside methyl ester, 8-acetyl-shanzhiside methyl ester, and 7-epiphlomiol. The main phytochemical characteristics of the Phlomis genus include the presence of iridoid glycosides and phenylethanoids such as verbascoside (acetoside), which is a caffeic acid sugar ester found in plant species of the Lamiales order.

3.4 Triterpenoids

Thirteen triterpenoid and related compounds have been identified from P. umbrosa roots, including oleanolic acid, corosolic acid, hederagenin, arjunolic acid, belleric acid, 3β-hydroxy-29-al-12-en-28-oleanoic acid, butyrospermol, β-sitosterol, daucosterol, caffeic acid, vanillic acid, p-hydroxybenzoic acid, and 3,4-dihydroxybenzoic acid. Novel nortriterpene skeletal types have also been discovered: two novel 28-noroleanane-derived spirocyclic triterpenoids with unusual skeleton structures, phlomisone (1) and phlomistetraol A (2), were isolated from the roots of Phlomis umbrosa.

3.5 Other Notable Constituents

P. umbrosa contains various phytochemicals such as betonicine, shanzhiside methyl ester, and succinic acid. Cytotoxic triterpenoids have also been identified: the fraction and isolates were evaluated for cytotoxic activity on cervical cancer (HeLa), human promyelocytic leukemia (HL-60), and breast cancer (MCF-7) cell lines; among them, phlomisu E, which possesses an aldehyde group, showed the most potent cytotoxic effect with an IC50 value of less than 10 μM.

4. Mechanisms of Action

4.1 Anti-inflammatory and Antinociceptive Mechanisms

Iridoid glycosides in some plants have been shown to have antinociceptive and anti-inflammatory activities; the contents of iridoid glycosides, reported as the main components of P. umbrosa, have been specifically investigated in this context. A study demonstrated that the aqueous extract of P. umbrosa had good antinociceptive and anti-inflammatory activities, indirectly substantiating the traditional use of P. umbrosa in inflammatory and pain disorders by local folklore practitioners.

In the context of asthma and allergic inflammation, treatment with a 20% ethanolic extract of P. umbrosa significantly attenuated the T helper type 2 (Th2)-based immune response, eosinophilia, histopathological changes, and biochemical parameters; furthermore, the extract inhibited interleukin (IL)-33-mediated activation of the NF-κB and TGF-β signaling pathways, and reduced fibrosis and apoptosis associated with inflammation. In network pharmacology analysis, effects of P. umbrosa were associated with MAPK signaling, and antiasthmatic effects were related to downregulation of the Erk/MMP-9 signaling axis.

4.2 Osteogenic and Anti-osteoporotic Mechanisms

Two distinct but complementary bone-related mechanisms have been identified. First, regarding anabolic/osteoblastic activity: oral administration of P. umbrosa significantly increased longitudinal bone growth rate, height of the hypertrophic zone, and chondrocyte proliferation of the proximal tibial growth plate; it also increased serum IGFBP-3 levels and upregulated the expressions of IGF-1 and BMP-2 in growth plate. P. umbrosa increases longitudinal bone growth rate by stimulating proliferation and hypertrophy of chondrocytes with the increment of circulating IGFBP-3.

Second, regarding anti-osteoclastic activity: Phlomis umbrosa Turcz significantly suppressed RANKL-induced osteoclast differentiation and bone resorption; it suppressed the activation of NF-κB in bone marrow macrophages treated with RANKL and M-CSF; and the mRNA expression of c-Fos, NFATc1, osteoclast-associated receptor (OSCAR), and tartrate-resistant acid phosphatase (TRAP) in bone marrow-derived macrophages was inhibited; integrin αν, β3 relating to cell adhesion, DC-STAMP relating to the structure of the F-actin ring, and cathepsin K relating to bone-resorbing activity were also disrupted.

4.3 Growth Hormone Axis Modulation

HT042 supplementation (a combination including P. umbrosa) helped to increase height growth in children without skeletal maturation, and the effects might be mediated by increases in serum IGF-1 and IGFBP-3 levels.

4.4 Muscle Protein Synthesis Pathway

Phosphorylations of mammalian target of rapamycin (mTOR), ribosomal protein S6 kinase beta-1, and eukaryotic translation initiation factor 4E-binding protein 1 were significantly enhanced in the P. umbrosa water extract (PUW) group, indicating activation of anabolic signaling. PUW alleviates muscle atrophy by modulating the balance between protein degradation and synthesis through regulation of the ubiquitin-proteasome system and PI3K/Akt/mTOR pathway.

5. Scientific Evidence by Area of Use

5.1 Bone and Skeletal Health

5.1.1 Longitudinal Bone Growth (Preclinical)

Oral administration of P. umbrosa significantly increased longitudinal bone growth rate, height of the hypertrophic zone, and chondrocyte proliferation of the proximal tibial growth plate. P. umbrosa also increased serum IGFBP-3 levels and upregulated the expressions of IGF-1 and BMP-2 in the growth plate. This was an animal (rat) study. Evidence for single-herb bone growth effects is therefore preclinical.

5.1.2 Anti-osteoporotic Effects (Preclinical)

ICR female mice were ovariectomized (OVX) to induce osteoporosis for 7 weeks; treatment with 1, 10, and 100 mg/kg P. umbrosa was administered orally to the OVX mice for 6 weeks. At the end of the experiment, the microstructure of the capital femoral epiphysis was investigated; the levels of bone mineral density (BMD), bone mineral content (BMC), and serum osteocalcin concentration were evaluated; and mineralized Saos-2 osteoblast cells were treated with 0.01, 0.1, and 1 µg/ml P. umbrosa to analyze the expression of osteoblast differentiation-associated factors. Evidence at this stage remains animal and cell-based; no clinical trials in osteoporosis patients with single-herb P. umbrosa have been identified in the peer-reviewed literature.

5.1.3 Osteoclast Inhibition (In Vitro)

The effects of Phlomis umbrosa Turcz on expression of RANKL-induced osteoclast differentiation in bone marrow-derived macrophages and bone resorption were examined. Phlomis umbrosa Turcz significantly suppressed RANKL-induced osteoclast differentiation and bone resorption. This is in vitro evidence only.

All three root extracts studied (including P. umbrosa) decreased osteoclastic bone resorption and inhibited TRAP-positive cell formations in a dose-dependent manner; only the D. japonicus extract demonstrated toxicity.

5.2 Children's Height Growth (Clinical Evidence)

The most substantiated clinical evidence for P. umbrosa involves its use within the multi-herb formulation HT042. HT042 is a standardized multi-herb mixture composed of the stem of Eleutherococcus senticosus and the roots of Astragalus membranaceus and Phlomis umbrosa. HT042 is a standardized functional food granted by the Korean Food and Drug Administration for promoting "Children's Height Growth."

First multicenter randomized controlled trial (2014): A double-blinded, randomized, placebo-controlled study was conducted to investigate efficacy of HT042 for short children; 99 children aged 7 to 12 years, all with an initial height below the 25th percentile for age and sex, were enrolled. The children were randomly assigned to receive 750 mg of HT042 or placebo twice daily for 12 weeks. Mean change in height from baseline to week 12 for children who received HT042 and placebo were 2.2 ± 0.7 and 1.9 ± 0.7 cm, respectively (p = 0.047); children in the HT042 group showed a significant increase in height percentile and height SDS from baseline to week 12 (both p < 0.001); treatment with HT042 significantly increased fat-free mass and decreased fat mass; there was a significant difference in the level of IGFBP-3 between placebo and HT042 groups at week 12 (3386.7 ± 737.0 ng/ml vs. 3064.7 ± 723.6 ng/ml; p = 0.039).

Second multicenter randomized controlled trial (2017, published 2018): HT042 supplementation helped to increase height growth in children without skeletal maturation and was more effective in much shorter children; the effects might be mediated by increases in serum IGF-1 and IGFBP-3 levels. The difference was elevated when the efficacy analysis was restricted to children below the 10th percentile (mean difference, 0.45 cm; 95% CI, 0.04 to 0.87 cm; p = 0.031); because bone age advancement was lower in the HT042 group, the height standard deviation score gain for bone age was higher in HT042 group, and the difference was significant in children below the 10th percentile (mean difference, 0.20 score; 95% CI, 0.00 to 0.39 points; p = 0.045).

Evidence strength: The clinical evidence for HT042 (the combination containing P. umbrosa) is based on at least two randomized, double-blind, placebo-controlled trials in children. However, because HT042 is a three-herb mixture, P. umbrosa's individual contribution cannot be isolated from these data. Although there are clinical studies on P. umbrosa, its pharmacokinetics need to be further elucidated, and it is limited in identifying active compounds and clarifying pharmacological mechanisms.

5.3 Menopausal Symptoms (Clinical Evidence)

P. umbrosa is a component (32.5%) of EstroG-100, a standardized herbal extract also containing Cynanchum wilfordii (32.5%) and Angelica gigas Nakai (35%). EstroG-100 (or FGF-271) is a standardized mixed root extract of Cynanchum wilfordii 32.5%, Phlomis umbrosa Turcz 32.5%, and Angelica gigas Nakai 35%.

Randomized double-blind, placebo-controlled trial (2012): This clinical research study was designed to evaluate the efficacy of EstroG-100, containing a mixture of standardized extracts of Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas, on menopausal symptoms. The trial was performed for 12 weeks with 64 pre-, peri-, and postmenopausal women who were randomly allocated to either the EstroG-100 group (n = 31) or the placebo group (n = 33). Primary endpoints were the mean change in Kupperman menopause index (KMI) scores and mean change in vaginal dryness scores. The mean KMI score was significantly reduced in the EstroG-100 group from 29.5 ± 7.4 at baseline to 11.3 ± 5.8 (p < 0.01) compared with change of the placebo group (29.2 ± 6.6 at baseline vs. 23.7 ± 7.7 at week 12).

Korean multicenter randomized controlled trial: The study investigated the safety and efficacy of EstroG-100, a combined herbal extract of Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai, in improving menopausal symptoms among Korean menopausal women; it was designed as a multicenter, randomized, double-blind, placebo-controlled trial in women aged 40–70 years with menopausal symptoms (KMI ≥ 20). The total modified KMI score significantly improved after a 12-week intake of EstroG-100 compared with placebo; of the secondary efficacy endpoints, paresthesia, nervousness, melancholia, vertigo, fatigue, arthralgia and myalgia, and formication improved significantly.

A standardized mixed herbal extract of Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas was observed to significantly improve the menopausal symptoms of pre-, peri-, and post-menopausal women without weight gain or any serious side effects.

Estrogenic activity evaluation: Some herbal medicines have been reported to increase the risk of estrogen-induced cancer; herbal formulations composed of a combination of Cynanchum wilfordii Hemsley, Phlomis umbrosa Turczaninow, and Angelica gigas Nakai extracts have been used for treating menopausal symptoms. Notably, the ingredient has been shown in three prospective, randomized, double-blind, and placebo-controlled clinical studies to be effective on menopausal symptoms without the typical side effects of hormone therapy such as weight gain or organ, circulatory, or metabolic changes, and no estrogenic or phytoestrogenic effect was identified.

Evidence strength: Clinical evidence for the EstroG-100 combination (containing P. umbrosa) for menopausal symptoms is based on multiple randomized, double-blind, placebo-controlled trials. As with HT042, the individual contribution of P. umbrosa within the mixture cannot be confirmed independently. The mechanism of relief does not appear to be estrogenic in the classical sense.

5.4 Osteoarthritis (Preclinical)

Dipsacus asperoides and Phlomis umbrosa, two species used in the Korean medicine "Sok-dan," are used for the treatment of bone- and arthritis-related diseases; to identify herbal resources with similar efficacy, the effects of D. asperoides extract (DAE) and P. umbrosa extract (PUE) on osteoarthritis (OA) were compared in a monosodium iodoacetate (MIA)-induced OA rat model. Evidence remains at the preclinical (animal model) level.

5.5 Allergic and Respiratory Conditions (Preclinical)

The efficacy of P. umbrosa in the treatment of asthma was investigated using a murine model of ovalbumin (OVA)-induced asthma; high-performance liquid chromatography (HPLC) was used to analyze the active ingredients; P. umbrosa effectively inhibited asthmatic responses. The animals were daily treated with P. umbrosa extract (PUE, 20 and 40 mg/kg) by oral gavage from day 18 to day 23.

A 2026 study further investigated the mechanism: the study aimed to evaluate the therapeutic potential of a 20% ethanolic extract of Phlomis umbrosa Turcz. and its associated bioactive compounds in an ovalbumin-induced allergic asthma mouse model. All asthma evidence to date is animal (preclinical) only.

5.6 Anti-inflammatory and Antinociceptive Effects (Preclinical)

The extract of P. umbrosa exhibits extensive pharmacological activities including anti-osteoporosis, anti-allergic, antibacterial, antinociceptive, anti-inflammatory, antioxidant, and anticancer activities. Previous studies have suggested that P. umbrosa has anti-inflammatory, antinociceptive, anti-allergy, and antioxidant activities. All reported evidence in these areas is preclinical (in vitro or animal studies); no standalone clinical trials for analgesic or anti-inflammatory endpoints have been identified.

5.7 Muscle Atrophy (Preclinical)

P. umbrosa water extract (PUW) administration effectively reversed the effects of muscle atrophy by maintaining muscle mass and strength, decreasing protein degradation-related marker expression, and enhancing signaling for protein synthesis; phosphorylations of mTOR, S6K1, and 4E-BP1 were significantly enhanced, indicating activation of anabolic signaling; PUW alleviates muscle atrophy induced by dexamethasone by modulating the balance between protein degradation and synthesis through regulation of the ubiquitin-proteasome system and PI3K/Akt/mTOR pathway. This is preclinical evidence only.

5.8 Cytotoxicity / Anticancer (In Vitro)

Calcelarioside B (10 μg/mL) in P. umbrosa had an inhibitory rate of 69.63% on HeLa tumor cells. These findings are limited to cell-based assays and have no clinical counterpart in the current literature.

6. Body Systems and Health Areas

Based on available peer-reviewed evidence, Phlomis umbrosa has been investigated in connection with the following body systems:

Musculoskeletal system: Bone growth stimulation (via IGF-1/IGFBP-3/BMP-2 pathways), anti-osteoporotic activity (via Runx2 upregulation and RANKL/NF-κB inhibition), treatment of rheumatic and arthritic disease, and prevention of muscle atrophy (via PI3K/Akt/mTOR).
Endocrine system: Modulation of the growth hormone axis (IGF-1, IGFBP-3); menopausal symptom relief in the context of the EstroG-100 combination, without classical estrogenic activity.
Immune and respiratory system: Attenuation of Th2-mediated allergic inflammation, eosinophilia, and asthmatic responses via IL-33/NF-κB/TGF-β signaling.
Integumentary and wound-healing: Traditional topical applications for wounds and bleeding, with hemostatic use described in classical texts; modern research on traditional applications of P. umbrosa such as treatment of fractures and hemostasis still urgently needs confirmation.
Gastrointestinal and general immune: HT042, composed of Astragalus mongholicus, Eleutherococcus senticosus, and Phlomis umbrosa, holds potential as an immunomodulator; HT042 demonstrated remarkable immune-enhancing effects, including the restoration of weight loss and hematological parameters, as well as enhancing NK cell activity.
Oncology (in vitro only): Cytotoxic activity of isolated compounds against HeLa, HL-60, and MCF-7 cell lines has been reported, but no clinical cancer evidence exists.

7. Dosage Forms and Reported Dosages

Dosages described below are drawn directly from peer-reviewed studies and should be understood solely as reported experimental or clinical research dosages.

7.1 Forms

P. umbrosa preparations reported in the scientific literature include aqueous (water) decoctions, 20% ethanolic extracts, standardized root extracts in tablet/capsule form, and combined standardized multi-herb extracts. Forms include teas, extracts, and supplements.

7.2 Dosages Reported in Human Clinical Studies

HT042 (containing P. umbrosa root extract as one of three herbs): Children were randomly assigned to receive 750 mg of HT042 or placebo twice daily for 12 weeks.
EstroG-100 (containing P. umbrosa root extract as one of three herbs): EstroG-100 is a standardized mixed root extract comprising Cynanchum wilfordii 32.5%, Phlomis umbrosa Turcz 32.5%, and Angelica gigas Nakai 35%; the EstroG-100 tablet in the clinical study was comprised of 257.05 mg of EstroG-100. This was administered as a tablet in the context of clinical trials for menopausal symptoms.

7.3 Dosages Reported in Preclinical (Animal) Studies

Osteoporosis (OVX mouse model): Treatment with 1, 10, and 100 mg/kg P. umbrosa was administered orally to OVX mice for 6 weeks.
Asthma (OVA mouse model): Animals were daily treated with P. umbrosa extract (PUE, 20 and 40 mg/kg) by oral gavage.
HT042 in spontaneous dwarf rats: Groups included a recombinant human GH group (rhGH; 500 µg/kg/day) and the HT042 (100 mg/kg/day) group.
Extraction method in safety study: A total of 100 g P. umbrosa was extracted with 1 liter of distilled water for 24 h at room temperature with shaking.

8. Safety Considerations

8.1 General Toxicological Profile

Almost no obvious toxicity or side effects have been observed and recorded for P. umbrosa. HT042 is a combination of three standardized extracts from Astragalus membranaceus root, Eleutherococcus senticosus stem, and Phlomis umbrosa root, which has proven to stimulate children's height growth; the aim of the toxicity study was to demonstrate the safety of HT042 and its three constituent herbs when administered orally; acute and sub-chronic oral toxicity studies were conducted using male and female Sprague-Dawley rats.

In the acute toxicity study, HT042 and each of the herbs was administered at single doses of up to 5000 mg/kg; in the 13-week sub-chronic toxicity study, HT042 was administered at repeated doses of up to 4000 mg/kg/day. This study was published in a peer-reviewed journal and indicates a wide safety margin in rodents at these doses.

8.2 Menopausal Studies: Absence of Estrogenic Effect

The EstroG-100 ingredient (which includes P. umbrosa) has been shown in three prospective, randomized, double-blind, and placebo-controlled clinical studies to be effective on menopausal symptoms without the typical side effects of hormone therapy such as weight gain or organ, circulatory, or metabolic changes, and no estrogenic or phytoestrogenic effect was detected. This is a meaningful safety consideration for patients concerned about estrogen-dependent conditions.

8.3 Misidentification Risk

The currently reported pharmacological effects of Dipsaci Radix and Phlomidis Radix are completely different: Dipsaci Radix is reported to have osteoprotective effects, whereas Phlomidis Radix is reported to have anti-inflammatory effects; therefore, indiscriminate application of these two herbal medicines can cause unforeseen side effects and threaten their use as medicines. This misidentification risk is a practical safety concern in Asian herbal markets.

8.4 Gaps and Limitations

Although there are clinical studies on P. umbrosa, its pharmacokinetics need to be further elucidated; it is also limited in identifying active compounds and clarifying pharmacological mechanisms; modern research on the traditional applications of P. umbrosa — such as treatment of fractures and hemostasis — should also be urgently confirmed.

Formal taxonomic authentication by a qualified botanist and deposition of a voucher specimen in a recognized herbarium were not performed for the plant material used in at least one recent study, which may limit taxonomic documentation and reproducibility of findings. This highlights the importance of standardization in research and commercial preparations.

No clinically meaningful drug–herb interaction data specific to P. umbrosa were identified in the peer-reviewed literature at the time of this writing. The lack of pharmacokinetic data — acknowledged in the literature — means interaction risks cannot currently be characterized from evidence-based sources.

References

Health Conditions

Health conditions that Phlomis umbrosa may help support.

No conditions available.

Body Systems

Body systems that Phlomis umbrosa may help support.

No body systems available.