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Clinical Studies
The results of
the clinical studies mirror those of the preclinical studies.
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The
Indian Council of Medical Research undertook an antidiabetic Phase II open trial at four
centers across India using Vijayasar (P. marsupium). Vijayasar was tested in
newly-diagnosed non-insulin dependent diabetes mellitus (NIDDM) patients between 35 and 60
years of age for 12 weeks. Ninety-three of 223 patients admitted for the therapy were
evaluated for 12 weeks. The parameters used for evaluation were blood glucose levels and
glycosylated hemoglobin (HbA1c). The main findings for the study are summarized
below and in Figure 1:
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Figure 1. Mean blood glucose and HbA1c levels of patients
during 12- week Vijayasar treatment. (No. of patients : Fasting blood glucose = 93,
Postprandial blood glucose = 93, & HbA1C = 67)
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Of
the three cardinal symptoms for diabetes, a marked reduction was observed for polyuria
(the production of large volumes of urine). The other two symptoms, symptomspolyphagia
(gluttonous excessive eating) and polydipsia (abnormally intense thirst), initially
observed in 21 and 7 patients respectively, disappeared in 14 and 7 patients, respectively
by 12 weeks.
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Control
of both fasting and postprandial blood glucose was achieved in 67 of 93 newly diagnosed or
untreated NIDDM patients. Approximately 73% of these patients required a daily dose of 2 g
of Vijayasar. Only 10% of the patients required a higher dose of 4 g per day, and this
dose was well tolerated.
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No
relationship was found between the dose of Vijayasar and the changes observed in the HbA1c
levels. Only 7% of the patients attained control of HbA1c by week 12.
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None
of the patients reported any side effects.
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The
Indian Council of Medical Research concluded that Vijayasar (P. marsupium) be used
in the treatment of newly diagnosed or untreated NIDDM patients. In addition they
suggested that the treatment be restricted to mild diabetics (those that have blood
glucose levels between 120 and 180 mg/dL and postprandial blood glucose levels between 180
and 250 mg/dL).
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Another
study on 20 patients with maturity onset diabetes mellitus was performed. The
patients were divided into two groups- Group A and Group B. Group A consisted of 10
patients who received Vijayasar (P. marsupium heartwood) granules (5 g tid after
breakfast, lunch, and dinner). Group B consisted of 10 patients who had received
conventional drugs such as chlorpropamide, tolbutamide, and phenformin before receiving
the Vijayasar granules. The study was conducted for 3 weeks. Significant reductions in the
fasting and postprandial blood sugar levels were observed after treatment with Vijayasar
that were comparable with the conventional drug therapies. Subjective improvements
concerning reduction of appetite, polyurea, polydipsia, burning pains in limbs and general
weakness were observed in a majority of cases within an 8-10 day period, and blood sugar
levels were controlled at the end of 2 weeks.
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Figure 2. Reduction of Fasting and
Post Prandial Blood Sugar Level of diabetic patients during a 3 week treatment
Group A: Vijaysar (Aqueous extract) granules
treated
Group B: Vijaysar treated after withdrawal
of oral hypoglycemics
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Two
other studies determined the blood sugar lowering effects of formulations containing P.
marsupium. in diabetic patients.
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Efficacy of D-400, a herbal preparation consisting of Eugenia
jambulana, Tinospora, cordifolia, P. marsupium, Ficus glomerulata, Momoradica
charantia and Ocimum sanctum were conducted. 20 cases of
persistent post prandial hyperglycaemia were selected for the study. Initial
reduction in body weight. blood glucose was observed. After 12 weeks of treatment,
rise in fasting and post prandial blood sugar was noticed in placebo treated groups.
While D-400 treated groups showed a persistent fall in fasting and post prandial
blood glucose level till the end of the trial. D-400 exibits benefical effects in
treating pontial diabetic cases and during trial period no adverse effects were observed.
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Figure 3. Effect of D 400 and Placebo on
fasting blood glucose levels in early diabetic patients
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Figure 4. Effect of D 400 and Placebo on
Post Prandial Blood Sugar Level in early Diabetic Patients
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Both
studies concluded that the formulations were beneficial in treating diabetic patients.
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Yajnik
and coworkers evaluated the hypoglycemic activity of D-400 in 43 patients with maturity
onset diabetes for 12 weeks. Of the 43 patients, 20 were newly diagnosed diabetics and 23
were diabetics already receiving oral and/or insulin treatment along with other forms of
treatment.
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After
the 12 week treatment, significant reductions in both the fasting and postprandial blood
sugar levels were observed in diabetics taking oral hypoglycemics as well as newly
diagnosed diabetics. (Figures 2 and 3)
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The
treatment satisfactorily controlled 90% of the newly diagnosed diabetics. |
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Approximately
and 80% and 20% of diabetics taking oral hypoglycemics were able to reduce the dosage of
their medications or cease taking their medication, respectively.
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The
treatment was well tolerated by all patients, and no harmful effects were reported. |

Figure 5. Effect of D-400 on fasting and
post-prandial blood sugar levels in newly diagnosed diabetics. (week (-2) to week 0 placebo treatment,
week 0 and week 12 D-400 treatment) N=20
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Figure 6: Effect of D-400 on fasting and
post-prandial blood sugar levels in newly diagnosed diabetics. (week (-2) to week 0 placebo treatment, week 0 and week 12 D-400 treatment) N=23
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Another
research group compared the antidiabetic effects of two ayurvedic
preparations- Gurmur, (a combination of the leaves of Gymnema sylvestre, Aegle
marmelos, and Azadirachta indica) and Bija wood water (Pterocarpus marsupium
water), in 30 diabetic patients aged 40-65. The Gurmur preparation significantly reduced
the post meal blood sugar levels to normal levels. P. marsupium exerted an
antidiabetic effect, but unlike the Gurmur preparation, the P. marsupium water
exhibited a slow and steady hypoglycemic activity as shown in fig. 7.
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Figure 7. Post meal blood sugar
level (mg%) in diabetic patients under treatment of Gurmur preparation and Vijaysar wood
water for one month(p<0.01)6
* Gurmur preparation discontinued after 7 days.
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A
subsequent study on two drugs - Saussurea lappa and P. marsupium
were administered seperately to 2 groups of patients 500 mg and 100 ml (decoction) each
for 30 days. The study reported favorable results in using P. marsupium in
the management of diabetes with no observed side effects.
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