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Assessment Report on Angelica Sinensis (Oliv.) Diels, Radix Based on Article 10A of Directive 2001/83/EC As Amended (Well-Established Use)

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Assessment Report on Angelica Sinensis (Oliv.) Diels, Radix Based on Article 10A of Directive 2001/83/EC As Amended (Well-Established Use) 9 July 2013 EMA/HMPC/614586/2012 Committee on Herbal Medicinal Products (HMPC) Assessment report on Angelica sinensis (Oliv.) Diels, radix Based on Article 10a of Directive 2001/83/EC as amended (well-established use) Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Final Herbal substance(s) (binomial scientific name of Angelica sinensis (Oliv.) Diels, radix the plant, including plant part) Herbal preparation(s) Liquid extract, dried liquid extract Pharmaceutical forms Oral solution, tablets Rapporteur W. Dymowski Assessor(s) 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ................................................................................................................... 2 1. Introduction ....................................................................................................................... 4 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof .. 4 1.2. Information about products on the market in the Member States ............................... 8 1.3. Search and assessment methodology ................................................................... 10 2. Historical data on medicinal use ...................................................................................... 10 2.1. Information on period of medicinal use in the Community ....................................... 10 2.2. Information on traditional/current indications and specified substances/preparations .. 11 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications: ..................................................................................... 12 3. Non-Clinical Data ............................................................................................................. 12 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 12 3.1.1. Primary pharmacodynamics .............................................................................. 13 3.1.1.1. Antithrombotic, antiplatelet activity ................................................................. 13 3.1.1.2. Antispasmodic activities ................................................................................. 14 3.1.1.3. Oestrogenic activity ...................................................................................... 15 3.1.2. Secondary pharmacodynamics .......................................................................... 16 3.1.2.1. Cytotoxicity and antiproliferative effects .......................................................... 16 3.1.2.2. Anxiolytic effect of the essential oil ................................................................. 16 3.1.2.3. Effects on the cardiovascular system ............................................................... 16 3.1.2.4. Protective effect of a polysaccharide fraction on the gastric mucosa .................... 17 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ........................................................... 17 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof ....................................................................... 18 3.4. Overall conclusions on non-clinical data ................................................................ 18 4. Clinical Data ..................................................................................................................... 19 4.1. Clinical Pharmacology ......................................................................................... 19 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 19 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ........................................................................ 20 4.2. Clinical Efficacy .................................................................................................. 20 4.2.1. Dose response studies...................................................................................... 20 4.2.2. Clinical studies (case studies and clinical trials) ................................................... 21 4.2.3. Clinical studies in special populations (e.g. elderly and children) ............................ 22 4.3. Overall conclusions on clinical pharmacology and efficacy ........................................ 22 5. Clinical Safety/Pharmacovigilance ................................................................................... 22 5.1. Overview of toxicological/safety data from clinical trials in humans ........................... 22 5.2. Patient exposure ................................................................................................ 22 5.3. Adverse events and serious adverse events and deaths .......................................... 22 5.4. Laboratory findings ............................................................................................. 23 5.5. Safety in special populations and situations ........................................................... 23 5.6. Overall conclusions on clinical safety ..................................................................... 23 Assessment report on Angelica sinensis (Oliv.) Diels, radix EMA/HMPC/614586/2012 Page 2/24 6. Overall conclusions .......................................................................................................... 23 Annex .................................................................................................................................. 24 Assessment report on Angelica sinensis (Oliv.) Diels, radix EMA/HMPC/614586/2012 Page 3/24 Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) According to European Pharmacopoeia, ed. 7.5 (1), the herbal substance contains the smoke-dried, whole or fragmented root, with rootlets removed, of Angelica sinensis (Oliv.) Diels collected in late autumn, containing minimum 0.050 per cent of trans-ferulic acid (C10H10O4; Mr 194.2). Assessor’s comments: The traditional processing of this root in China doesn’t contain a washing process, like in the case of other roots used in Europe. There is no information on cleaning of root surface. It is not clear what microbiological flora is present on the surface of the material after smoke-drying. According to data from Korea and Vietnam, for the microbiological decontamination of the Dang gui root, radiation sterilisation is used. According to the Pharmacopoeia of the People’s Republic of China (1977), Radix Angelicae sinensis (Danggui) was used “To enrich blood, activate blood circulation, regulate menstruation, relieve pain and relax bowels”. According to the TCM theory, different parts of Angelicae sinensis radix possess different traditional applications. The whole root (Quan Danggui) is used to quicken, nourish and harmonise blood; root head (Danngui Tou) is used to quicken the blood and to stop bleeding; root body without head (Danggui Shen) consisting of the main body of the root without head and tails is used for nourish the blood when blood quickening properties are not desired; root tails (Danggui Wei) consisting of the primary branch roots is considered to elicit the strongest effect for quickening the blood and breaking up blood stasis; finer roots (Danggui Xu) (“beard”) are used to quicken the blood and free the network vessels. In practice, in herbal trade Danggui Tou is actually the two parts of Danggui Tou and Danggui Schen but Danggui Xu is parts of Danggui Tou and Danggui Schen but Danggui Xu is rare on the market. The species Angelica sinensis (Oliv.) Diels was described in Bot. Jahrb. Syst. 29 (3-4): 500.1900 [4 Dec 1900] on the basis of an earlier description of Angelica polymorpha Maxim. var. sinensis Oliv. Hooker’s icon. Pl. 20: t. 1999. 1891 [Aug 1891] (IPNI). According to the Flora of China ([email protected];) the species Angelica sinensis (Oliver) Diels (Dang gui) is a perennial plant, 0.4 - 1 m of height, with cylindric branched and succulent roots that have many rootlets and are strongly aromatic. The plant is further described as follows (Zehui & Watson, 2005): Stems purplish green, ribbed, branched above. Basal and lower petioles 5 - 20 cm, sheaths purplish green, ovate, membranous-margined; blade ovate, 10 - 30 × 12 - 25 cm, 2 - 3-ternate- pinnate, pinnae 3 - 4 pairs, proximal and middle pinnae long-petiolulate; leaflets ovate or ovate- lanceolate, 2 - 3.5 × 0.8 - 2.5 cm, 2 - 3-lobed, margin irregularly coarse-cuspidate-serrate, sparse papillate-hairy along nerves and margin. Peduncles 8 - 20 cm, pubescent or subglabrous; bracts absent or 2, linear; rays 10 - 30, unequal, scabrous; bracteoles 2 - 4, linear, 3 - 5 mm; umbellules 13 - 36-flowered; pedicels slender, 1 - 3 cm in fruit.
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