Development of a prototype for standardization of crude extracts using the antidiarrhoeal extract of Psidium guajava (guava) leaves as an example.
Standardization of medicinal plant extracts is important for uniform efficacy and wider acceptability. Optimization of extracts is frequently guided by analysis of single compounds. Yet activity of many plant extracts cannot be clearly linked to single compounds due to synergism or chemical complexity. Hence, metabolomics which provides detailed knowledge about the extracts’ spectral metabolite profile and its impact on biological activity can be used for development of standardized extracts that factually contain a whole range of compounds relevant for efficacy.
The study plans to utilize this approach using the example of the guava leaf extract (GLE) to demonstrate its utility in the standardization of crude extracts. It involves screening of the GLE prepared from leaves collected in different seasons and from different geographical locations in multiple assays reflecting diarrhoeal pathogenesis and correlating them with their NMR profile. This would be the first step towards a more discerning method of standardization of crude plant extracts.
This approach would be one of the first where the profile from an open cultivation will be correlated to multiple bioassays used to measure efficacy.
DOCUMENTING THE EFFICACY OF GUAVA (Psidium guajava) LEAF DECOCTION FOR TREATING PATIENTS WITH DIARRHOEA
The extensive research already undertaken by FMR has demonstrated that the guava leaf decoction (GLD) is effective against a spectrum of diarrhoea causing pathogens and so can be used without identifying the causative agent: a useful feature for underserved areas. Additionally, due to its diverse mechanisms of action the guava decoction could act at multiple stages of the disease process and thus possibly minimize drug resistance.
Since the GLD is mentioned in Ayurveda, ayurvedic physicians can prescribe it without additional clearances. The trial will be conducted at the Department of Integrative Medicine Medanta Hospital, Gurgaon. The department is well recognized and experienced in treating patients in an integrated manner (allopathy + ayurveda) and in the undertaking of integrated clinical trials. This will permit treatment with the decoction and evaluation by allopathic standards. Adults presenting with infectious diarrhoea will be treated for 5 days with GLD. The patients will be divided into 4 groups (30 patients each) consisting of 3 doses of GLD and a control group on regular treatment.
The evidence generated from this clinical trial is crucial to generate confidence which will allow FMR to access funding for development of a formulation and to collaborate with industry for its manufacture. Additionally, it will provide information regarding dosage to be used in the formulation and the sample size for future multi-centric double blind clinical trials.
Infectious diarrhoea accounts for nearly 20% of child deaths in India. High levels of antibiotic resistance among diarrhoea causing bacteria has been reported. Additionally, side effects of antibiotics and supra infections when normal flora is eradicated are also some of the other complications of aberrant use of antibiotics. Additionally the cost of therapies needs to be taken into account when considering developing countries.
In recent decades the popularity of herbal medicine has grown exponentially. According to the World Medicine Situation Report, nearly 67% population of India does not have access to essential medicines. Due to this lack of access and traditional beliefs an estimated 65% of rural India uses traditional medicine as a source of primary health care. Thus an important niche exists for development of cost effective alternative approaches for the treatment of diarrhoea and medicinal plants may serve to fulfil this niche resulting in the inclusion of Traditional Medicine in the WHO diarrhoea control programme.
Literature reveals a wealth of publications on anti-diarrhoeal medicinal plants in India. About 560 species of plants are used for the treatment of diarrhoea in the alternative medicinal systems of India. Despite the large variety of plants listed, relatively few formulations are available for its treatment. Based on studies undertaken by FMR on Sissoo, Kurchi, Karanj, Bael, Musta, Guava and Ginger, the guava leaf extract was found to be the most efficacious. The results indicated that the guava leaf extract may be effective in controlling diarrhoea caused by a wide spectrum of bacteria. Literature also reports its efficacy against non-infectious diarrhoea. This implies that it can be used without identifying the causative agent: a useful feature for underserved areas. Additionally, due to its diverse mechanisms of action the guava decoction could act at multiple stages of the disease process and thus possibly minimize drug resistance.
Based on the work undertaken at FMR, a clinical trial is proposed which will provide evidence for efficacy thereby generating confidence towards the development of a formulation. The use of Guava leaves in the treatment of diarrhoea is mentioned in Ayurveda and Unani literature and therefore can be prescribed by Ayurvedic physicians.
Since crude extracts are often more efficacious than isolated fractions, studies are also proposed on newer approaches for standardization of crude extracts. This is important for developing a formulation with uniform efficacy and wider acceptability using crude extracts thereby serving as a prototype for modernization of traditional medicine.
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