CLINICAL RESEARCH DATA ON EACH INGREDIENT

VIJAYSAAR (PTEROCARPUS MARSUPIUM)
Anti-diabetic property of Pterocarpus marsupium is mentioned by a number of authors. The
aqueous extract of the heartwood was tried on rabbits, and ws found to exert favourable
results, in diabetic patients. The Hypoglycaemic response of the alcoholic and aqueous
extracts after oral administration of 0.75 gm./kg. of Heartwood of Pterocarpus marsupium and the changes in blood sugar level of testing rabbit is reported below (TABLE 1):

TABLE 1

DRUG

NO. OF OBSERVATION

MEAN % REDUCTION IN BLOOD SUGAR TOUCH + S.E.

1ST HOM

2ND HOM

3RD HOM

5TH HOM

CONTROL

6

5.0±1.98

6.6±3.5

6.6±2.19

3.1±1.00

ALCOHOL

10

20.7±6.46

23.3±5.46

27.4±4.71

25.1±2.10

AQUEOUS

10

12.3±3.71

21.2±5.03

24.7±3.24

28.7±4.27

REFERENCE: IND JOUR. MED RES. 55(2), p 166-168
 

Rajasekharan et. al. (1976) had conducted a clinical trial in drug Pterocarpus and had
observed its effect on Urine sugar, polyurea, polydipsia, polphagia, and also on Blood sugar
fasting. The datas indicate that the drug effectively lowers the sugar contents in urine and
significantly reduce the blood sugar level

(Jour. Res. Ind. Med. Yoga & Homoeo. 11 (2), 1976, P. 9-15)

 

An active constituent of Vijaysar, Pterocarpus marsupium 1- epicatechin (Fig 1) have been reported to reverse Hyperglycemia in alloxan diabetic rats when given before or within 24 hrs. after the dose of alloxan. Sheehan et. al (1983) J. Nut Prod. 46(2), 232-234 have conducted an experimental trial on this active component on alloxanised rabbits and the results of which are tabulated below (Table 11)  Figure 1 (-) Epicatechin  

graph1

 

histological studies of pancreas of these animals showed regeneration of the beta cells
population of the islets which were earlier necrosed by alloxan. Immuno reactive Inlulin (IRI)
studies showed that the regenerated B-cells of the islets of pancreas are functional in nature.

fig2 fig3 fig4

Pancreatic islet with betacells from control albino rat Gomori's Aldehyde Fuchsin X 100

Selective beta-cell necrosis, 5 days
following alloxan. Gomori's Aldehyde
Fuchsin X 500

Islet with well defined beta-cells after treatment with (-) epicatechin (5 days) Gomori's Aldehyde Fuchsin X 500

 

The authors have also reported their observations of Regeneration of B-cells islets in the Lancet issue 1981, p. 759 as well. The results of the Hypoglycaemic activity of 1-epicatechin is tabulised as below (Table 111)

Table111

  NORMAL
CONTROLS

(GROUP A)

ALLOXAN
24 HOURS

(GROUP B)

CONTROL
5 DAYS
ALLOXANISED RATS
(GROUP C)
(-) EPICATECHIN
TREATED

(GROUP D)

BLOOD SUGAR




SERUM INSULIN




BETA CELLS
(PER ISLET ACTION)
90.4
±1.5
(20)
A1

9.4
±2.4
(6)
A2

35.1
±2.0
(12)
A3

 

460.6
±42.7
(20)
B1

 




11.4
±3.6
(12)
B3

350.4
±21.2
(20)
C1

3.2
±1.2
(8)
C2

15.6
±0.8
(12)
C3

105.7
±18.6
(20)
D1

14.8
±4.3
(10)
D2

34.9
±1.9
(12)
D3


GUDMAR (GYMNEMA SYLVESTRE)

Gudmar a slender, twining shrub belonging to family Asclepideceae grows in India, South East Asia, tropical Africa and Australia, is a well known drug for hypoglycaemic property. The drug has been claimed to exert "anti saccharine" (anti sweetening) action.


George M. Hocking made a review of drug and reported in Acta Phytother 9(7), 134-136, that in the better control of D. mellitus, the dried leaves have been used in a form of chewing gum, reported to relieve the thirst and abnormal taste of diabetic patient.


Hypoglycaemic activity of Gymnema sylvestre, was reported by Mitra et. al. when the drug
treatment had reduced post lunch blood sugar of 217 mg. % to 125 mg. % in the diabetic
patients. No specific side effects or toxicity was observed in the patients (Bull, Calcutta Trop. Med. 1975, 23 (1-4), p. 6-7)


P.G. Institute of Basic Medical Sciences, Madras haas studied the effect of Hypoglycaemic
principle from Gudmar (Gymnema sylvestre) on the metabolic changes of total protein bound
polysaccharide components and glycosaminoglycogens in serum and tissues (brain, liver,
kidney etc.) of tats during short term alloxan induced hyperglycaemia. The levels of some
protein bound polysaccharides, hexoses, hexoses, hexuronic acid, non-amino polysaccharides and sialic acid, heparan sulfate registered an increase in the diabetic state. Treatment with Gymnema extract (GS2) for a month, restored these elevated levels to near normal values. The levels of 3 chonodroitin sulfates which showed a decrease in diabetic animals were restored to normal by GS2 administration. The results of these datas are summarised below as Table IV:


Table IV: BLOOD GLUCOSE LEVELS IN CONTROLS, TREATED CONTROLS, UNTREATED DIABETIC & GS2 TREATED DIABETIC RATS AS A SEQUALAE TO AN ORAL DOSE OF GLUCOSE (GLUCOSE TOLERANCE TEST)

Experimental group

( Values, expressed as mg/100ml. are mean + SD) Blood sugar level

Fasting 15min 30min 60min 120min
1 Controls 60±7.07 114±8.94 156±10.74 88±8.36 54±8.94
la GS2 treated Controls (Non Diabetics 56±6.70 113±7.80 156±4.56 85±7.45 51±8.50
II Diabetics 106±6.52 166±9.61 203±8.47 157±13.50 124±9.62
IIa GS2 treated diabetics 53±4.57 112±12.80 15±4.75 102±1.83 59±5.49


 
TABLE V: LEVELS OF SERUM PROTEIN BOUND POLYSACCHARIDES OF CONTROL AND DIABETIC RATS WITH AND WITHOUT GYMNEMA TREATMENT

(Values, expressed as mg/100ml. are mean ± SD)

Experimental
group
Total neutral hexoses Total
hexosamine
Fucose
Sialic
acid
Non aminopoly
saccharides
Total
hexuronic
1 Controls
(non-diabetic)
226.9±21.48 50.5±5.73 15.5±2.46 89.6±32.94 142.8±15.88 45.3±3.43
Ia Treated
(non-diabetic)
233.6±29.27 93.6±15.73b 16.2±1.94 160.0±11.36 188.2±39.76 48.1±8.73
IInd Untreated diabetic 297.6±68.94 123.9±18.00 15.8±2.82 192.0±46.67b 208.8±35.68a 70.4±5.10a
IIA treated diabetic 209.7±28.09 111.2±12.45 11.3±1.34a 155.7±8.51 140.5±25.71b 48.7±3.66a

    Group Ia is compared with 1, Group II is compared with I, Group IIA is compared with II. P Valuesa 0.05b, 0.01c, 0.001.

 

AMUN PATR (SYZYGIUM CUMINI)

The parts used for therapeutic anti-diabetic effect are seeds, fruits and the leaves. The hypoglycaemic activity of Syzygium cumini was ducumented by various authors. Ghose S.C. et.al (1974. Drugs of india, VIIth ed., P. 275-286) have stated the drug as powerful remedy for disappearance of sugar in the urine. If long standing dyspeptic irubles be present along with diabetic symptoms Syzygium will be found to be a sovereign remedy.

Gutpa et.al. (1963, Ind. J. Med. Sci. 57:501), have reported that the aqueous extract of the drug influence on the glucose tolerance through indirect pancreotropic effect due to sensitisation of B-cells of the islets of langerhans

The Hypoglycaemic activity of extractives of leaves contents of Syzygium cumini were experimented by Abdul et. aI. (1989), who have published that the alcohol & aqueous extractives of drug leaves have shown significant hypoglycaemic activity in normal and Hyperglycaemic adult rabbits. The results were comparable to tolbutamide. The mode of action of drug has been established as stimulating the B-islets cells of langerhans to secrete more insulin, and also by increasing the utilisation of sugar either by direct stimulation of sugar uptake or via the mediation of enhanced insulin secretion. (Hypoglycaemic activity of E. Jambolana leaves; Pakistan Journal of Med. Res. Vol.28, No. 3p. 165-168)


METHI SEEDS (SEEDS OF TRIGONELLA FOENUM GRACEUM)

Methi (Fenugreek) seed is a nature's great boon to mankind and its regular use will help keep the body healthy. Methi is widely available being extensively cultivated in India & North Africa. The medicinal use of Methi Seeds have also been known for a long time. Methi seeds, in Greek & Latin Pharmacopoeias as have been described to posses anti diabetic activity. (ref.1-3)

1. Sharma P.V. (1983), Dravaguna Vijana Vol. 2,p. 684-685

2. Sharma P.V. (1983), Ibid 103-105

3. Sarma P.V. (1983), Ibid p. 659-660


Flouier (Plant Medicinales et. verene usesde France, Paris 111, 495) observed that infusion of coarsely ground fenugreek seeds improved severe diabetes in human subjects. Seeds as well as extractives of Trigonella foenumgraceum were administered to rabbits to study the hypoglycaemic activity using Glucose Tolerance Test (GTT). A significant hypoglycaemic activity of alkaloid rich fraction has been observed. The data results of the observation are tabulated below as reported by Jain et. aI. (1987) ind.J. Pharm. Sci. 49 (3), 113-114), which on comparison have shown a satisfactorily significant hypoglycaemic effect.

 

TABLE VII: HYPOGLYCAEMIC ACTIVITY OF TRIGONELLA FOENUM-GRACEUM

Treatment Single Dose
(per kg. bocy wt.)
Mean%reduction from initial blood glucose level.
hours after administration
1/2 2 4
Distilled water   31.60+2.10a 19.90+2.56 5.97+2.27
Tolbutamide 300 mg. 5.48+1.44 18.15+1.46a 42.24+1.43a
Seeds 3g 16.69+0.51 39.03+0.02a 39.38+0.04a
Aqueous ext. 300mg -28.07+1.30 19.08+0.38b 20.19+0.44a
Methanolic ext. 300 mg. -10.96+5.48 19.65+3.79b 28.97+3.35a
Alkaloid rich Fraction 300 mg. 16.50+4.86c 56.16+2.31a 36.10+3.36a
Control   133.33+3.69 121.52+4.51 107.28+4.02

Sharma R.D. (1986, Nutrition Research, Dec. 6, 1353-1364) had found significant reduction in fasting blood glucose and in GTT of normal healthy individuals and non-insulin dependent diabetics. The results were attributed to fibre content and delayed intestinal absorption of glucose.

Hypocholestremic effect of Methi is another major field of its therapeutic efficacy. Singh et. al. (1982)-Curr, Science, Feb. 5, 51(3), p. 136-137, have reported the effect of Fenugreek seeds on normal and Hypercholesterolemic rats, and the potent Hypochoilesterolemic activity of drug is tabulated below:-

 

TABLE VIII : SERUM CHOLESTEROL LEVELS IN NORMAL AND HYPERCHOLESTEROLAEMIC RATS AND THEIR STATISTICAL SIGNIFICANCE.

Group Rats Diet Serum cholesterol
initial After 1 week After 2 weeks P value
I Normal control 93+7 92+7 92+7 Not Significant
III Normal 50% seeds 99+8 70+13 57+2 0.000005
II Hypercholesterolemic Control 203+11 199+13 199+11 Not Significant
IV Hypercholesterolemic 50% seeds 189+13 127+7 79+18 0.000005

(Values are mean ± SD and are expressed in mg/d!)

A report (1990) from Israel, published in J. Agri Chem.38(7),p. 1535-1539, reveals that the gel fraction of drug decreased both digestion and absorption of starch and uptake of bile acid (toourocholate and deoxycholate) when feeded to rats (in vivo). Their studies also indicate that the gel fraction i.e. galactomannan, in the seeds of fenugreek in the factor which may be of potential, benefit of fenugreek seeds in controlling plasma glucose and cholesterol levels (fig.5&6). The data's of results of gel fraction of fenugreekk seed on Potato starch Digestin and uptake the bile acids are tabulated below:

GEL FRACTION
CONC.MG
a Glucose (mg) liberated in INHIBITION
SEROSAL SIDE MUCOSAL SIDE TOTAL
0 3.5±1.500 43.9±1.5 47.3±1.5
80 1.5±0.30 35.2±1.1 36.7±0.9 23
160 0.3±0.10 28.3±0.8 28.6±0.9 39
320 0.4±0.03 27.8±0.9 28.1±1.2 41
600 0.2±0.12 21.8±0.7 21.8±0.6 54

aResults are expressed as means ±SEM of five experiments (5rats) with total of 15 gut sections. bThe inhibition percentage was calculated as the ration of total glucose in presence and absence of the gel fraction.

 

graph3

Figure 5. Change in plasma glucose level in respose to starch (O) or starch plus gel fraction (O) derived from fenugreek. (A) the starch (0.5g / 100g.b.w. ) (B) The gel fraction was given 30 min prior to starch. Results are the mean ± SEM or 10 rats p<0.05.

Figure 6. Changes in plaxma glucose level in response to starch (O) or starch plus ethanolic fraction (O) derived from gel fraction. Results are mean ± SEM of 10 rats p<0.05

TABLE X: EFFECT OF DIFFERENT CONCENTRATIONS OF THE GEL FRACTION DERIVED FROM FENUGREEK SEED ON UPTAKE OF 14C DEOXYCHOLIC ACID (0.3 mM) AND TAUROCHOLATE (03mM) IN RAT INVERTED SAC (LOWER PART OF THE ILEUM)

Gel concn. Radioactivity found (pdomx 103) Of
(14C) deoxycholic acid (14C) taurocholate
mg. of dry matter Serosal Side Mucosal side Serosal side Mucosal side
0 21±4.3 213±1.9 8±0.2 85.4±0.9
5 20±0.2 184±6.9 10.7±1.6 76.1±2.2
10 19±1.7 198±3.2 9.1±0.9 74.9±0.3
20 16±3.2 167±0. 4.2±0.5 68.8±3.2
40 9.5±2.1 153±16.8 4.0±0.7 61.8±4.6
80 7.4±1.9 106±2.8 2.7±0.1 40.7±1.3
160 1.9±0.1 103±6.4 1.2±0.3 34.1±1.1

Results are expressed as mean ± SEM of five experiments

NEEM PATRA (AZADIRACHTA INDICA)

Aqueous decoction of fresh tenders of Neem Partra, when taken internally orally appear to have benefitted the diabetic patients, as per reports of various clinical and social studies. Murty et.al. (1978, Ind. J. Pharmac, 1(2), 247-250) have investigated for effect of Neem Patra on blood glucose levels in dogs, and had observed to have hypoglycaemic and anti-hyperglycaemic effects. The results as indicated below in table & figure indicates that the drug significantly decreases the blood sugar levels (Table XII) Azadirachta Indica prevented glucose induced Hyperglycaemia as well (Fig.7)

TABLE: XI: HYPOGLYCAEMIC EFFECT OF AZADIRACHTA INDICA EXTRACT ON NORMAL BLOOD SUGAR LEVEL IN DOGS

  Mean blood sugaar level (mg%±S.E.)
Groups No. of Expts. Initial Final
Control 11 76.18±2.71 76.15±2.57
Estract 12 87.48±4.28 70.37±4.67

P 0.01

TABLE XII: EFFECT OF AZADIRACHTA INDICA EXTRACT ON ADRENALINE INDUCED HYPERGLYCAEMIA IN DOGS

  Mean blood sugar level (mg%+ S.E.)
Initial 1/2H 1H 2H 3H 4H
Control(10) 64.04±4.37 95.79±4.67 130.97±6.34 137.72±5.04 141.47±7.33 133.0±9.44
Extract(10) 69.27±9.18 92.01±9.18 78.29±7.13 68.47±8.39 63.7±6.78 64.22±7.82

 

GULAR PATRA (LEAVES OF FICUS RACEMOSA)
Dietary fibres of Gicus racemosa when fed at the 10% dietary level to rats, induced a greater resistance to hyperlipidaemia than cellulose. They influence total lipids, cholesterol, triglycerides and phospholipds of liver to varying extent, hence recommended in the condition of Hypercholesterolaemia and Hyperglycaemia, as per the reports published in Plant foods for Human Nutrition 38, 189-197 (1988). Gular Patra has also been reported to bring down glucose levels both in fasting and Post parandial due to hypoglycaemic activity of B-sitosteryl-d-glucoside present in the leaves (Ambica & Rao, Ind. J. Pharm. 29, 91). Neera Singh et. al. (1991) have reported the anti hyperglycaemic activity of Gular extract when tested on alloxan diabetic albino rats. The study also revealed that the Hypoglycaemic activity was irreversible till a fortnight of discontinuation of treatment. (Journal of NIMA -
Feb. 1991, p. 9-12)

GILOE (TINOSPORA CORDIFOLIA EXTRACT)
Giloe (Tinospora cordifolia) has been known for long in Ayurvedic literature as tonic vitalizer, and as a remedy for diabetes and metabolic disorders (Chopra et. aI.)., Gupta et, aI, (Ind.J.Med.Res. 55(7), P. 733-745) have established the hypoglycaemic effect of aqueous and alcoholic extract of drug, especially in pituitary and adrenaline induced hyperhlycaemia, and have found to increase the Glucose tolerance in albino rats.
Extract of Tinospora cordifolia (Wild) Miers had been investigated for hypoglycaemic and antihyperglycaemic effects in normal and diabetic rats. Extract administered orally by intubation in the doses of 20 mg/100 g body weight showed a moderate hypoglycaemic effect. Propranolol, insulin and tolbutamide in combination with cordifolia had got synergistic effect. Extract also had induced a significant fall in glyucaemic levels in rats with glucose induce hyperglycaemia. It had shown antihyperglycaemic effect on moderate alloxan diabetic rats with blood sugar not exceeding 400 mg./dI, but was ineffective in severe alloxan diabetic rats.

(International Seminar - Traditional Medicine - Calcutta - 1992 p. 9.17)