Binomial Name Trigonella Foenum Graceum Biology Essay

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Fenugreek, Trigonella foenum-graecum L., is an erect annual herb native to southern Europe and Asia. Undoubtedly one of the oldest cultivated medicinal plants, fenugreek is widely grown today in the Mediterranean countries, Argentina, France, India, North Africa, and the United States as a food, condiment, medicinal, dye, and forage plant. The plant reaches a height of 0.3 to 0.8 meters and has a hollow stalk from which smaller branches emerge, each with three pointed leaves. White flowers [figure 1] appear in early summer and develop into long, slender, yellow-brown pods [figure 2] containing the brown seeds of fenugreek [figure 3] which are used in medicine.

The sown seeds sprout in 3 days, and the plant grows inherently resistant to most infestation and diseases (Srinivasan, 2006). Greens are harvested at the 3 to 4 leaved stage, after which saponin content increase, making them more bitter. The seeds are harvested 30-35 days after flowering or 155-165 days after sowing.

The ripe seeds of fenugreek have a strong characteristic aromatic odour. The seeds are hard, flattened, brown to reddish-brown and more or less rhomboidal with rounded edges, and tend to be 3 mm to 5 mm long, 2 mm to 3 mm wide and 1.5 mm to 2 mm thick. The widest surfaces are marked by a groove that divides the seed into two unequal parts. The smaller part contains the radicle; the larger part contains the cotyledon (Anon, 2007).

The reported life zone of fenugreek is 8 to 27 degrees centigrade, with an annual precipitation of 0.4 to 1.5 meters and a soil pH of 5.3 to 8.2. The plant thrives in full sun on rich, well-drained soils. As a leguminous plant, fenugreek needs little if any nitrogen fertilizer, and the plant can enrich soils with nitrogen.

Figure 2 - Plant with ripening fruit Figure 3 - Fenugreek Seeds

2 - ETHNOBOTANY

Historical overview:

Fenugreek has a long history of medical uses, it was prescribed with dates as a medicament in the teachings of Prophet Mohammed (Peace be upon him) over 1400 years ago, and since then it has been widely used in the Middle East region. The oldest prescribed fenugreek was recorded by Ancient Egyptians 1500 BC for burns, fertility, incense and to embalm mummies. In the 5th century BC, Greek physicians considered it a valuable calming plant, and in the 1st century it was considered a remedy for all types of female ailments, including vaginal inflammation. In ancient Rome, fenugreek was used to aid labour and delivery. In traditional Chinese medicine, fenugreek seeds are used for nutrition, kidney ailments, beriberi, hernia, impotence, as a tonic, as well as a treatment for weakness and edema of the legs (Basch, 2003).

 

It has been said that if people knew the benefits of fenugreek, they would pay its weight in gold. The English scientist, Klebber once said that "if all medicine was placed on one side of the scales and fenugreek was place of the other, fenugreek would be heavier." The strength of fenugreek lies in its dryness and its hot, spicy taste.

Traditional Medical Uses:

As a medicinal plant, fenugreek has traditionally been considered a carminative, demulcent, expectorant, laxative, and stomachic. The plant has also been employed against bronchitis, fevers, sore throats, wounds swollen glands, skin irritations and infections, diabetes, ulcers, mouth ulcers, boils, cellulites, and in tuberculosis. Fenugreek has been used to promote lactation, to increase libido (sexual derive) and as an aphrodisiac (an agent that stimulates sexual desire). The seeds' soothing effect makes them of value in treating gastritis and gastric ulcers.

Traditional Recipes:

Fenugreek is nowadays used all around the world and not only in the Middle East for its nutritional value and as a medicine. Many traditional dishes incorporate the seeds especially those made for women just before and after labour.

Boiled in water, fenugreek tea is used to treat urinary difficulties, menstrual difficulties, diarrhoea, reduce fever and muscle tension.

For rheumatism and muscle pain, the powdered seeds are mixed with garlic paste and a little sesame oil to massage the areas of pain

Used to induce the menstrual cycle in girls at puberty (spoon twice a day).

To relieve vaginal pain caused by ulcers, a handful of fenugreek seeds is boiled in 3 litres of water for 10 minutes. This water is later cooled and the woman is to sit/bathe in it.

Fenugreek oil, when taken by lactating women at the rate of 20 drops three times a day, doubles the amount of milk. Or 1.5 teaspoons of the seeds are simmered in a cup of water for 10 minutes. One cup must be drunk 3 times a day.

When cooked with dates, honey, or figs, it relieves mucus in the chest and chronic cough.

A spoonful of seeds boiled in water for 10 minutes is used for chest pain, especially asthma and coughing.

A spoonful of powdered seeds three times after meals reduces sugar level in blood.

Increases appetite when soaked in water for two hours and used just before eating.

A cup of the fenugreek's soaked seeds daily on an empty stomach kill stomach worms.

Powdered fenugreek seeds are mixed with honey (1 to 1), and used three times daily to treat stomach and intestinal ulcers.

For burns, powdered fenugreek is used with rose oil.

For broken skin and improving skin colour, boiled fenugreek is used.

For puss sacs and eczema, the powdered seeds are mixed with enough warm water to make a paste which is used on the infected area.

Topically, fenugreek is used as a poultice for local inflammation, myalgia, lymphadenitis, gout, wounds, leg ulcers and eczema (Jellin JM, et al, 2000)

Dosage:

Typical adult dosage ranges:

2g/day of dried seed (although much higher doses have been used, up to 25g/day for hypoglycaemic and hypolipidaemic activities)

2mL/day of a 1:1 liquid extract

2 to 4.5 mL/day of a 1:2 liquid extract or equivalent in tablet or capsule form (Mills and Bone, 2005).

Medical uses of other parts of the plant:

The nutrient component of fresh fenugreek leaves is listed in Table (1) (Srinivasan, 2006). These green leaves are very nutritious, because they are rich in proteins, ascorbic acid, niacin, and potassium. The leaves also contain choline and tricholine which are similar in structure to nicotinic acid (play essential roles in energy metabolism in living cells and DNA repair). 

Component

Fresh Fenugreek Leaves *

Fenugreek Seeds *

Moisture

86.0g

-

Protein

4.4g

30g

Fat

1.0g

7.5g

Fiber

1.0g

50g

Sapogenins

-

2g

Trigonelline

-

380g

Ca

395mg

160mg

Mg

67mg

160mg

P

51mg

370mg

Fe

16.5mg

14mg

Na

76mg

19mg

K

31mg

530mg

Cu

0.26mg

33mg

S

167mg

16mg

Cl

165mg

165mg

Mn

-

1.5g

Zn

-

7.0mg

Cr

-

0.1mg

Choline

1.35g

50mg

Vitamin C

52mg

43mg

Î’-Carotene

2.3mg

96 µg

Thiamine

40µg

340 µg

Riboflavin

310 µg

290 µg

Nicotinic acid

800 µg

1.1mg

Folic acid

84 µg

Table (1) - Composition of fresh fenugreek leaves and mature fenugreek seeds

* (Values expressed per 100g)

Other non-medical uses:

Due to its maple flavour, fenugreek is used as a flavouring agent in imitation maple syrup, foods, sweets, candies, beverages and tobacco (Jellin, et al., 2000). In other manufacturing processes, fenugreek extracts are used in soaps and cosmetics. The seeds are soaked and then powdered to make lip balm and tonic. It is also used in veterinary medicine, being added to feed in order to improve the appetite of domestic animals, and to flavour cattle food (Sharma, 1990). The mucilage from the seeds is used to give finish to certain fabrics in the textile industry. Fenugreek is an important honey plant (Sharma, 1990), and has been reported to have insect and pest repellent properties (Srinivasan, 2006).

3 - PHYTOCHEMISTRY

Constituents: 45-60% carbohydrates, chiefly mucilage located on the cell walls in the endosperm (galactomannans): 1,4-β-glycosidiacally bound mannose chains with α-glycosidically bound galactose chains, together with a small proportion of xylose; fibrous and starchy materials, as well as oligosaccharides are also present. 20-30% protein and 6-10% fixed oil (Bisset, 1994).

Fenugreek contains approximately 4 to 8% saponins and about 1% alkaloids, contributing to bitterness, gastric stimulation, increased acidity, and increased appetite. Diosgenin, a steroid sapogenin found in fenugreek but currently isolated from the Dioscorea species, is the starting compound for over 60% of the total steroid production by the pharmaceutical industry. Other sapogenins found in the fenugreek seed include yamogenin, gitogenin, tigogenin, and neotigogens. Other constituents of fenugreek include mucilage, volatile oil, and the alkaloids choline and trigonelline.

The extractable oil from fenugreek, which is about 6-8%, has a foetid odour and bitter taste. It has a specific gravity of 0.91, acid value 1-2, saponification value 178-183, iodine value 115, unsaponifiable matter 3.9%, and fatty acid composition of palmitic 9.6%, stearic 4.9%, arachidic 2%, oleic 35.1%, linoleic 33.7%, and α-linolenic 13.8%. About 0.02% is volatile oil with anethole as the major component (Srinivasan, 2006).

Fenugreek extracts are obtained by alcoholic extraction, and the seed is the main part used. Although most fruit and vegetables have insoluble fiber, fenugreek has soluble fiber. Nearly 50% dry weight is edible dietary fiber, making it the highest concentration among all natural sources of fiber. About 30% of fenugreek seed is gel-forming soluble fiber similar to guar gum and oat bran. The insoluble fiber, which constitutes 20% of fenugreek seed, is bulk-forming like wheat bran. Fenugreek is endospermic (contains endosperm; a tissue produced in the seeds around the time of fertilization, which surrounds the embryo and provides nutrition in the form of starch).

Figure 4 - Bioactive chemical constituents of fenugreek (Bisset, 1994)

4 - PHYTOPHARMACOLOGY (Animal and in-vitro studies)

Safety of Fenugreek

Fenugreek was reported to be absolutely safe for consumption based on a long-term animal study. Hematological parameters, histological observations, liver function parameters, and feed efficiency ratio in rats fed fenugreek at 5-20% in their diet for 90 days remained comparable to controls (Udayasekhara, 1996). Debittered fenugreek was evidenced to be safe following oral exposure at 2g/kg body weight in mice and 5g/kg body weight in rats and at 10% level in the diet fed to growing rats in a cumulative toxicity study (Muralidhara, 1999).

Diabetes

Preliminary animal trials suggest possible hypoglycemic and antihyperlipidemic properties of fenugreek seed powder (Srinivasan, 2006). The hypoglycaemic effect of fenugreek was previously attributed to its major alkaloid - trigonelline (Srinivasan, 2006). Now there is much evidence to believe that the hypoglycaemic effect of fenugreek is attributable to its fibre and gum. The gel-forming dietary fibre reduces the release of insulinotropic hormones and gastric inhibitory polypeptides. Fenugreek seeds are an excellent source of dietary fibre and hence, are advantageous in the context of diabetes (Chatterjee and Prakashi, 1995). Epidemiological studies have shown that in regions such as Japan and India where intake of dietary fiber is high, diabetes is less frequent than in Western countries where the fiber intake is low.

The effect of the dietary fibre fractions of fenugreek seeds on serum fructosamine, insulin and lipid levels, and on platelet aggregation in type-2 diabetic rats was investigated by administrating fenugreek orally twice daily at a dose of 0.5g/kg for 28 days. Lowered serum fructosamine level with no change in insulin level was reported (Hannan, et al., 2003).

The galactomannan-rich endosperm isolated from fenugreek seeds was studied for its beneficial antidiabetic effect by feeding it to the streptozotocin-induced diabetic rats at 3% dietary level for 6 weeks. Excretion of insulin was significantly lowered in fenugreek endosperm-fed diabetic animals (Ramesh and Srinivasan, 2004). A single oral dose of fenugreek has also been reported to be beneficial. Pre-treatment of fenugreek suspension 1hr prior to glucose load in rats caused significant decrease in blood glucose at 30, 60 and 90 min indication reduced rate of gastric emptying (Madar, 1984).

The mechanism of action of an orally active hypoglycaemic principle isolated from water extract of seeds of fenugreek was investigated in alloxan-induced subdiabetic and overtly diabetic rabbits (Puri, 2002). The active principle was orally administered to the subdiabetic and mild diabetic rabbits (5 in each group) at a dose of 50 mg/kg body weight for 15 days, there was a significant attenuation of the glucose tolerance curve and improvement in the glucose-induced insulin response, suggesting that the hypoglycaemic effect may be mediated through stimulating insulin synthesis and/or secretion from the pancreatic beta cells of Langerhans. Prolonged administration of the same dose of active principle for 30 days to the severely diabetic rabbits lowered fasting blood glucose significantly, but could elevate the fasting serum insulin level to a lower extent, which suggests an extra-pancreatic mode of action for the active principle. The effect may also be by increasing the sensitivity of tissues to available insulin. The hypoglycaemic effect was observed to be slow but sustained, without any risk of developing severe hypoglycaemia.

Fenugreek and Cancer

Cancer is the second leading cause of death worldwide (Amin, et al., 2005). Conventional therapies cause serious side effects, cancer control may therefore benefit from alternate therapies. Researchers are studying fenugreek for its potential effectiveness as a cancer chemopreventive. It is thought that fenugreek may help to prevent cancer by raising levels of vitamin C, vitamin E, and other antioxidants in the bloodstream. In a study, the potential protective effect of fenugreek seeds against 7, 12-dimethylbenz(alpha)anthracene (DMBA)-induced breast cancer in rats was demonstrated (Amin, et al., 2005). It was found that at 200mg/kg, the fenugreek seeds extract significantly inhibited the DMBA-induced mammary hyperplasia and decreased its incidence. Epidemiological studies also implicate apoptosis as a mechanism that may mediate the fenugreek's anti-breast cancer protective effects.

Fenugreek and Lactation:

(Alamer, 2005) conducted a study to evaluate the effect of fenugreek on milk production in 12 lactating goats. Six gouts were fed 60g/day fenugreek seed powder for seven weeks while the other six served as controls. Milk yield was recorded daily and blood samples were collected twice a week. Milk yield was found to be significantly higher in the treated group (1236±38 vs. 1093±43 ml/day). Mean plasma levels of the growth hormone were also significantly higher in the fenugreek fed goats (0.27±0.09 and 0.21±0.02 ng/ml). It could be concluded that fenugreek feeding increases milk production in goats and this effect may be via growth hormone stimulation.

Lipid Control & Ulcer Protective Effects

In another study, beneficial decrease in serum lipids, LDL cholesterol and triglyceride levels were reported without any effect on high-density lipoprotein (HDL)-cholesterol. Oral administration of fenugreek fraction (100mg/kg) for 15 days improved glucose tolerance in alloxan diabetic rabbits. Serum insulin was also increased, along with a reduction in free fatty acids (Murthy, et al., 1990). In addition, fenugreek seeds have also prevented the rise in lipid peroxidation induced by ethanol presumably by enhancing antioxidant potential of the gastric mucosa and thereby, lowering mucosal injury.

The gastroprotective effect of fenugreek seeds has been shown in a study on ethanol induced gastric ulcers (Pandian, et al., 2002). The aqueous extract and a gel fraction isolated from the seeds showed significant ulcer protective effects. The cytoprotective effect of the seeds seemed to be not only due to the antisecretory action but also to the effects on mucosal alycoproteins. Moreover, studies have shown the ability of fenugreek leaves to improve body weight and liver glycogen, and showed a significant effect on key carbohydrate metabolic enzymes in diabetic rats (Srinivasan, 2006).

5 - CLINICAL PHARMACY (Human Studies - in vivo)

Safety of Fenugreek

The safety and efficacy of Trigonella foenum-graceum extract was investigated in report of (Adel-Barry, et al., 2000) 20 male volunteers aged 20 - 30 years. Volunteers were randomly treated with either 40mg/kg aqueous extract powder in 10ml distilled water or 10ml distilled water in which coffee simulated the extract. The extract significantly lowered blood glucose level by 13.4%, 4 hours after the investigation. A significant change of 14.1% was observed in potassium levels. No significant alteration in serum cholesterol, total serum protein and blood urea occurred. Its hypokalaemic effect must however be further investigated.

Fenugreek and Type 2 Diabetes:

It was found that fenugreek seeds exert hypoglycaemic effects by stimulating glucose dependent insulin secretion from pancreatic beta cells (Ajabnoor and Tilmisany, 1988), as well as by inhibiting the activities of alpha-amylase and sucrase (Amin, 1987) two intestinal enzymes involved in carbohydrate metabolism.

Study (Gupta, 2001) reports that in a small randomized, controlled, double-blind trail to evaluate the effects of fenugreek seeds on glycemic control, 25 newly diagnosed type 2 diabetes patients (fasting glucose  200 mg/dl) were randomly divided into two groups. Group I received 1gm/day hydroalcoholic extract of fenugreek seeds and Group II received usual care (dietary control, exercise) and placebo capsules for two months. The study results showed that at baseline, both groups were similar in anthropometric and clinical variables. Oral glucose tolerance test, lipid levels, fasting C-peptide, glycosylated haemoglobin, and HOMA-model insulin resistance were also similar at baseline. Fasting blood glucose levels were reduced in both groups (148.3 mg/dL to 119.9 mg/dL in the fenugreek group versus 137.5 mg/dL to 113.0 mg/dL in the 'usual care' group). There were no significant differences between groups in mean glucose tolerance test values at the study's end. The authors did however note differences between groups in the area under the curve for blood glucose and insulin levels. The HOMA model derived insulin resistance showed a decrease in percent beta-cell secretion in group 1 as compared to group 2 and increase in percent insulin sensitivity. This study suggests that fenugreek extract and diet/exercise may be equally effective in attaining glycemic control in type 2 diabetes. However, the trial may be too small or brief to detect significant mean differences between groups.

Another study (Raghuram, et al., 1994), reports the results of a randomized, controlled, crossover trial of fenugreek seeds in 10 patients with type 2 diabetes. The doses of these patients' antidiabetic drug, glibenclamide, ranged from 2.5-7.5 mg per day; both medication dose and dietary intake were stabilized prior to the actual study periods. The patients were given either 25g powdered fenugreek seeds in two equal doses with meals or meals without fenugreek supplementation for 15 days. Five patients were randomized to receive fenugreek during the first 15-day period; the other five during the second period. Patients were then crossed over an additional 15 days. Improvements were recorded in the fenugreek-treated patient's glucose tolerance test scores and serum-clearance rates of glucose (control group, 153±11.92 mg/mL/min; fenugreek group 136.4±6.36 mg/mL/min. Larger studies are however needed to confirm these results.

(Sharma and Raghuram, 1990) conducted two randomized, controlled, crossover studies in patients with type 2. The doses of 15 patient antidiabetic drugs, glibenclamide / glipizide / metformin, were reduced by 20% and both medication dose and dietary intake were stabilized for one week prior to the actual study periods. In the first study, subjects ate meals with or without 100g of defatted fenugreek seed powder for 10 days. Patients were then crossed over an additional 10 days. Seven of the 15 patients received the fenugreek diet first. The second study was similar except that the duration was 20 days and the total subject number was five (three patients received the fenugreek diet first). Significant changes were recorded, the reduction in the fenugreek patients fasting blood glucose ranged from 179±24 mg/dL to 137±20.2 mg/dL in the first study and 157±22.2 mg/dL to 116±17.1 mg/dL in the second study. The decrease in 24-hour urinary glucose excretion in both studies was statistically significant. The fenugreek-treated patient group also reported subjective improvements in polydipsia and polyuria.

Fenugreek- Type 1 Diabetes:

(Sharma, et al., 1990) conducted a randomized, controlled, crossover trial in 10 patients to investigate the effect of fenugreek seeds on both blood glucose and the serum lipid profile in insulin-dependent (Type 1) diabetic patients. Isocaloric diets with and without fenugreek were each given randomly over a 10-day period. 100g of defatted fenugreek seed powder, divided into two equal doses, was incorporated into the diet and served during lunch and dinner. The fenugreek diet significantly reduced fasting blood and improved the glucose tolerance test. There was a 54% reduction in the 24hr urinary glucose excretion. The study suggests that fenugreek may aid with insulin secretion. In addition, the same study (Sharma, et al., 1990) reported small but significant level reductions in serum total cholesterol (approximately 1.3 mMol/L), low density lipoprotein cholesterol (LDL-C) (approximately 1.0mMol/L), VLDL cholesterol and triglycerides. The level of high density lipoprotein cholesterol (HDL-C) remained however unchanged.

Lipid & Cholesterol Control

In thy study of (Sharma, et al., 1996a,b), normalization of lipid profiles was observed in 60 patients with type 2 diabetes whose diets were supplemented with 25g powdered fenugreek per day for 24 weeks. While mean TC, LDL-C and TG levels decreased by 14-16% during the study period, mean HDL-C levels increased by 10%. Another study (Sowmya and Rajyalakshmi, 1999), reported a decrease in total cholesterol levels in 5 diabetic patients treated with fenugreek powder, 25g orally per day for 21 days. In study (Bordia, 1997), the effects of fenugreek powder were investigated on subjects who had coronary artery disease and type 2 diabetes. TC and TG levels decreased with no change in the HDL-C level.

Authors of a study (Sharma, et al., 1991) investigated 15 non-obese subjects that have ingested 100g defatted fenugreek powder per day for 3 weeks, their triglyceride (TG) and LDL-C levels were lower than baseline values. Slight decreases in HDL levels were also noticed. These effects may be due to sapogenins, which increase biliary cholesterol excretion, in turn leading to lowered serum cholesterol levels. The lipid-lowering effect of fenugreek might also be attributed to its estrogenic constituent, indirectly increasing thyroid hormone T4

Other

Other evidence suggests the seed consumption might decrease calcium oxalate deposition in the kidneys. The fenugreekine constituent shows evidence of cardiotonic, hypoglycemic, diuretic, anti-inflammatory, antihypertensive and antiviral properties (Jellin JM, et al, 2000).

6 - SIDE-EFFECTS AND INTERACTIONS

Adverse reactions including known allergies:

Fenugreek is generally recognized as safe but its safety is not well-documented for use in small children, lactating women, or persons with liver or kidney disease. A saponin-rich extract, like that of fenugreek, induces release of testosterone in males, increases secretory functions and induces uterine contractions in females (Srinivasan, 2006). For this reason, fenugreek extract and leaf must be contraindicated in women during early pregnancy to avoid risk of fetal loss, and during menstruation to reduce risk of excessive bleeding.

Occupational exposure to fenugreek can cause asthma, and after inhalation of the seed powder, it can cause allergic symptoms, such as a runny nose, wheezing, and fainting. The paste of fenugreek applied to the scalp can cause allergic symptoms, including head numbness, facial swelling, and wheezing (Jellin JM, et al, 2000). Fenugreek may also cause a maple syrup or curry odour in the patient's sweat and urine which is caused by the potent aroma compound sotolone.

Possible interactions with herbs and dietary supplement:

Herbs with anticoagulant/antiplatelet potential: As fenugreek constituent includes coumarin, concomitant use of herbs that have coumarin constituents or affect platelet aggregation could theoretically increase the risk of bleeding in some people (Mills and Bone, 2005). These herbs include: angelica, anise, arnica, asafoetida, bogbean, boldo, capsicum, celery, chamomile, clove, danshen, feverfew, garlic, ginger, ginkgo ginseng, horse chestnut, horseradish, licorice, meadowsweet, prickly ash, onion, papain, passionflower, poplar, quassia, red clover, turmeric, wild carrot, wild lettuce, willow, and others.

Possible interactions with drugs:

Fenugreek can enhance anticoagulant activity, and should not be used with other herbs or medications (heparin, warfarin, ticlopidine) that have this effect due to increased risk of bleeding. With large doses, hypoglycaemia is possible, fenugreek can lower blood sugar to a marked degree; blood sugar levels should be monitored closely, particularly in people taking insulin, glipizide, or other hypoglycaemic agents. Medications that are being taken to control diabetes may need to have dosages adjusted, which should be done under medical supervision (Amin, et al., 2005).

In theory, since fenugreek is high in mucilage, it can alter the absorption of any oral medication. Corticosteroid and other hormone treatments may be less effective. Monoamine oxidase inhibitors (MAOIs) may have increased activity when used in conjunction with fenugreek.

7 - RELEVANCE OF MEDICAL USE

The past two decades have seen a worldwide upsurge in the use of traditional medicine (TM) and complementary and alternative medicine (CAM). With such widespread use, the development of national policies and regulations on TM/CAM has become an important concern for both health authorities and the public.

In the State of Kuwait, the following is required by the Pharmaceutical and Herbal Medicines Registration and Control Administration of the Ministry Of Health in application for the drug's registration and marketing approval [MD201/].

An application form containing the drug's general data, pharmaceutical data, pharmacological and toxicological data, and clinical data (signed and stamped from the manufacturer).

The manufacturer's company profile - all manufacturers must be certified and registered by the local drug regulatory authorities.

A "Letter of Appointment" legalized by the Arab-UK chamber of commerce and from Kuwait's Embassy in the manufacturer's country.

Legalized manufacturing license and GMP certificate.

Legalized "Free Sale" certificate, mentioning the name, quantitative composition and status of registration of the product in the country of origin.

Manufacturing method of the product with details.

Certificate of analysis of the finished product.

Raw materials specification for both active and inactive ingredients.

Stability studies (long term and accelerated) for three batches covering full shelf life, at suitable different intervals with quantitative methods of analysis.

Legalized C&F price certificate with whole and retail price in country of origin.

List of countries where the product is registered and marketed with the registration number and date.

8 - CONCLUSION

Fenugreek has a long history of medical uses, and has been used for numerous indications. Preliminary animal and human trials suggest possible hypoglycaemic and antihyperlipidemic properties of oral fenugreek powder. Figure 5 summarises the multi-beneficial physiological effects of fenugreek that have been experimentally proven in recent decades, and which have the potential of possible therapeutic applications.

Fenugreek is a dietary supplement that may hold hope for diabetics (who are also at increased risk of cardiovascular morbidity and mortality). The generated data will hopefully lead to the development of well-designed, adequately powered, randomized, clinical trials evaluating the effect of fenugreek seed powder on measures of insulin resistance, insulin secretion, cholesterol metabolism, lactation and anti-cancer effect#p.

Currently, fenugreek is official in the Pharmacopoeia of the People's Republic of China and is official in the European Pharmacopoeia. In the US, fenugreek is freely available as a "dietary supplement" under the Dietary Supplement Health and Education Act of 1994.

FENUGREEK

GALACTAGOGUEUE

CHOLESTEROL-LOWERING

DIGESTIVE STIMULANT

ANTIOXIDANT

GASTROPROTECTIVE

&

HEPATOPROTECTIVE

ANTIDIABETIC

Figure 5 - Summary of multi-beneficial physiological effects of fenugreek (Srinivasan, 2006)

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