**5.1 Quality**

302 New Advances in the Basic and Clinical Gastroenterology

 *Punica granatum* is a deciduous shrub or small tree that is native to the Himalayas in north Pakistan and Northern India. Bark, rind of the fruit and seeds of this plant are used in folk medicine to treat diarrhea. Methanol extract of seeds of *P. granatum* dose dependently reduced castor oil induced diarrhea. It also significantly inhibited gastrointestinal motility and PGE2 mediated enteropooling in rats (Das et al., 1999).

*Ficus bengalensis* Pre-clinical Tannin Mukherjee et al *Eugenia jambolana* Pre-clinical Tannin Mukherjee et al *Ficus racemosa* Pre-clinical Tannin Mukherjee et al *Leucas lavandulaefolia* Pre-clinical Tannin Mukherjee et al *Geranium mexicanum* Pre-clinical (-)-epicatechin, tyramine Calzada et al *Galla chinensis* Pre-clinical Gallic acid Chen et al

betulinic acid

*Satureja hortensis* Pre-clinical Carvacrol Hajhashemi et al *Thespesia populnea* Pre-clinical Unknown Viswanatha et al *Mitragyna speciosa* Pre-clinical Mitragynine & other alkaloids Chittrakarn et al

In IBD oxidative stress mediates disease progression by disrupting epithelial cell integrity. Acetic acid-induced colitis is helpful to screen herbs which can inhibit cytotoxic effects of reactive oxygen species (ROS). Dextran sulphate sodium (DSS)-induced colitis is also a frequently used animal colitis model in ethnopharmacological studies. This model is useful to test the effect of herbs on inflammatory cytokines mediated cellular injury (Dieleman et al., 1998). The transgenic rat model (HLA-B27) with overt chronic gastrointestinal tract

 *Zingiber officinale* is traditionally used to treat inflammatory gastrointestinal disorders. Ethanolic extract of dried rhizomes of ginger displayed protective effects against acetic

 *Cordia dichotoma* is a deciduous tree with many medicinal uses in Ayurveda. Traditionally bark of the plant is reported for the treatment of ulcerative colitis. Methanolic extract of C. Dichotoma improved lesions and reduced colonic myeloperoxidase (MPO) and malondialdehyde (MDA) in acetic acid induced UC in

 *Patrinia scabiosaefolia* is a commonly used herbal medicine in Korea. It is used traditionally to treat colonic inflammations. Methanolic extract of P. Scabiosaefolia significantly attenuated dextran sulfate sodium induced colitis in mice. In addition, it

*Punica granatum* Pre-clinical Tannin Das et al

*Chaenomeles speciosa* Pre-clinical Oleanolic acid, ursolic acid &

Table 2. Plants and their active constituent(s) with anti-diarrheal activity

inflammation also serves to screen medicinal herbs to treat IBD.

acid-induced ulcerative colitis in rats (El-Abhar et al., 2008).

**Evidence Active Constituent(s) Reference** 

Chen et al

**Plant Scientific** 

**4. Inflammatory Bowel Diseases (IBD)** 

male swiss mice (Ganjare et al., 2011).

**4.1 Animal models of IBD** 

The quality of herbal medicines is important to ensure their safe use and efficacy. In contrast to well characterized conventional medicine, assurance of the quality of herbal medicine is a major concern. The problems associated with the herbal products include deliberate or accidental inclusion of prohibited or restricted ingredients, substitution or adulteration of herbal materials, contamination with toxic substances and differences between labelled and actual contents (Barnes et al., 2nd ed). However, increased consumer awareness and

Pharmacology of Traditional Herbal Medicines and Their Active Principles

investigation of such plants.

 pharmacokinetics toxicology

contraindications

**6. Conclusion** 

'safe' may not be valid by today's health standards.

 adverse effects and their frequencies drug–herb and food–herb interactions

**5.3 Safety** 

Used in the Treatment of Peptic Ulcer, Diarrhoea and Inflammatory Bowel Disease 305

specific quantity of one or several compounds. As the herbs are of natural origin, their chemical composition is affected by several factors (climate, growing conditions, time of harvesting, storage conditions and processing). Therefore, the use of standardized herbal extracts in preclinical and clinical research is helpful to develop evidence based traditional therapies. Although rigorous clinical investigations are lacking at present for many herbs used in GIT disorders, there is a vast literature on the *in vitro* and *in vivo* pharmacological effects of medicinal plants. These pre-clinical observations provide a rationale for further

The positive attitude towards herbal medicines is based on the testimony that herbs have been used since antiquity and the belief that they have the advantage of being 'natural' rather than 'synthetic'. Traditional healing systems employed herbal medicines for the symptomatic management of diseases. However, these herbs are now being used extensively for health promotion and disease prevention not only in underdeveloped and developing nations, but also increasingly in developed nations. As little is known regarding adverse effects of herbal medicines and their frequencies, the chronic exposure of these herbal ingredients may pose health risks. In particular, when herbs are extracted and purified, their toxicity might be increased due to increased concentration of potential toxic compounds. Therefore, the common assumption that herbal medicines are by inference

Generally, traditional herbal medicines lack the following pharmacological data in humans:

use in vulnerable individuals: children, elderly, individuals with renal or hepatic

Phytochemical and pharmacological (preclinical and clinical) studies are important to address the above issues. The majority of the herbs mentioned in this chapter are tested only in animals. The main focus of these studies has been determining the efficacy of herbal extracts to support their traditional claims. However, it is a common procedure in these animal studies to measure toxic dose of herbal extracts. These toxicological studies are important to provide in vivo data in a whole animal situation on the dose and adverse effects of herbal extracts which may be relevant when tested in humans. None of these studies have reported any major

The use of plants in treating diseases is a very old human tradition. This knowledge, derived from observations and experiences, has been handed over from generation to generation

pharmacologically active chemical constituents and their metabolites

disease, gender effects, individuals with a different genetic profile

adverse events in the experimental models of various GI disorders.

mechanisms of action of active constituents/whole extract


Table 3. Plants and their active constituents for treatment of ulcerative colitis/IBD

regulatory agencies' strict guidelines on the quality and stability of herbal products has led to significant improvements in the quality control of herbal medicines. Recently the herbal manufacturing industry has focused on improving its quality assurance and quality control mechanisms to guard against the frequent episodes of substandard quality and possible adulterations. Use of high-performance liquid chromatograms, thin-layer chromatography, atomic absorption spectroscopy, gas chromatography and where necessary more sophisticated techniques such as NMR and LC/MS has now become common in complementary medicines manufacturing industries to ensure the quality of plant materials and final product (Rosenbloom et al., 2011). The emphasis on good manufacturing practice has steadily increased over years. In addition, new regulatory laws are now in place on product stability to support its shelf life. With the steady progress on different herbal quality control fronts, it is now possible to apply almost the same set of quality standards as for conventional medicines. As most of the traditional herbs listed in this chapter are not commercially manufactured, the data on the quality of these plant medicines is scarce.

#### **5.2 Efficacy**

Herbal medicines have a long history of traditional use. However, from today's stand point, traditional claims need to be verified. A well-designed randomized controlled trial is essential to determine the efficacy and safety of herbal medicines. The use of standardized herbal extracts in clinical trials is important to obtain reproducible data on the efficacy and safety of herbal medicines. Standardization of herbal extracts has become a common practice in phytomedicines. It allows the establishment of reproducible pharmaceutical quality by comparing a product with established reference substances and by defining the specific quantity of one or several compounds. As the herbs are of natural origin, their chemical composition is affected by several factors (climate, growing conditions, time of harvesting, storage conditions and processing). Therefore, the use of standardized herbal extracts in preclinical and clinical research is helpful to develop evidence based traditional therapies. Although rigorous clinical investigations are lacking at present for many herbs used in GIT disorders, there is a vast literature on the *in vitro* and *in vivo* pharmacological effects of medicinal plants. These pre-clinical observations provide a rationale for further investigation of such plants.
