Clinical Studies

The results of the clinical studies mirror those of the preclinical studies.

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:

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)

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.

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.

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.

None of the patients reported any side effects.

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).

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.

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

Two other studies determined the blood sugar lowering effects of formulations containing P. marsupium. in diabetic patients.

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.

Figure 3.  Effect of D 400 and Placebo on fasting blood glucose levels in early diabetic patients

Figure 4.  Effect of D 400 and Placebo on Post Prandial Blood Sugar Level in early Diabetic Patients

Both studies concluded that the formulations were beneficial in treating diabetic patients.

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.

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)

The treatment satisfactorily controlled 90% of the newly diagnosed diabetics.

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.

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)

Figure 6: Effect of D-400 on fasting and post-prandial blood sugar levels in newly diagnosed diabetics. to week 0 placebo treatment, week 0 and week 12 D-400 treatment) N=23

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.

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.

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.