The Antiseptic 2004; 101(11), 487-494

Evaluation of the clinical efficacy and safety of Diabecon in NIDDM

In a study of 50 patients aged 30-60 years diagnosed with NIDDM, a significant reduction was observed in Fasting Blood sugar level (FBSL) and Post prandial blood sugar levels in patients newly diagnosed with NIDDM. There was a highly significant reduction in FBSL of patients who consumed Diabecon along with other OHAs. There was also significant improvement in general symptoms in both groups of patients. There were no significant changes in the hematological and biochemical parameters. There were no adverse reactions and overall compliance to the treatment was excellent.

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The Indian Practitioner, (1997): (50), 7, 589-593

Diabecon (D-400) in the Treatment of Diabetes Mellitus

ABSTRACT

Efficacy and safety of Diabecon (D-400) was assessed in thirty NIDDM patients (15 freshly diagnosed diabetic patients and 15 diabetic patients already on a very high dose of OHA).Findings of the present study revealed a significant reduction in fasting and postprandial blood sugar levels as well as in glycosylated haemoglobin levels (p<0.1), in both the groups. However, no significant change was observed in plasma insulin and blood lipid levels after Diabecon (D-400) treatment. Withdrawal of the drug was not required in any patient and no side-effects were observed. Diabecon (D-400) did not affect hepatic, renal and haematological functions in any patient during or after months of treatment. All the patients reported a sense of well-being. Diabecon (D-400) can be used alone or in combination with other OHA’s in the treatment of non-insulin dependent diabetes mellitus.

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Effect of Diabecon on sugar-induced lens opacity in organ culture: mechanism of action

J Ethnopharmacol. 2005 Feb 28;97(2):397-403. Epub 2005 Jan 18.

Cataract is the leading cause of blindness worldwide. Apart from ageing, diabetes has been considered to be one of the major risk factors of cataract. The high sugar levels in diabetes may cause tissue disruption and intumescences by osmotic changes induced via aldose reductase (AR) mediated polyol pathway. Therefore, agents that can inhibit AR and prevent sorbitol accumulation may be helpful to combat sugar-induced cataract. In the present study, AR inhibitory activity of Diabecon (an herbal drug used for diabetes) was studied together with its effect against sugar-induced lens opacity in organ culture. Diabecon aqueous extract (DAE) showed potential inhibitory activity with an IC50 value of 10 microg/ml against rat lens AR. Incubation of goat lens with supraphysiological concentrations of glucose (100 mM) led to the loss of lens transparency associated with increased AR activity, decreased soluble protein and increased protein carbonyls and glycation. Addition of DAE (0.3 mg/ml) to the medium preserved transparency and ameliorated the decrease in lens soluble protein due to hyperglycemia and also prevented the formation of glycated protein. Interestingly DAE inhibited aldose reductase activity in lens incubated with 100 mM glucose. DAE decreased protein carbonyls, prevented the loss of beta(L)-crystallin against 100 mM of glucose. We have also demonstrated here that most of these effects are mainly due to Gymnema sylvestre, one of the constituent herbs of Diabecon. These results suggest that Diabecon protect the lens against sugar-induced cataract by multiple mechanisms.

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Eur J Drug Metab Pharmacokinet. 1999 Jan-Mar;24(1):79-82.
Pharmacokinetic interaction of Diabecon (D-400) with rifampicin and nifedipine.
Mitra SK, Sundaram R, Venkataranganna MV, Gopumadhavan S.
R & D Centre, The Himalaya Drug Co., Bangalore, India.
Abstract
In the present study, Diabecon (D-400), a herbomineral anti-diabetic preparation, was studied for its pharmacokinetic interaction with the commonly used drugs rifampicin and nifedipine. Interaction of Diabecon with rifampicin: The pharmacokinetic interaction of rifampicin and Diabecon (D-400) was studied in animal models as well as in healthy human volunteers. Twelve rabbits were divided into two groups of six each. Animals in group I were treated with rifampicin (100 mg/kg body weight, p.o.) and group II with rifampicin (100 mg/kg body weight, p.o.) and Diabecon (D-400) (1 g/kg body weight, p.o.) for a period of 8 days. Rifampicin levels in plasma were estimated on day 1 and day 8 at 2, 4, 6 and 8 h after drug administration. On the basis of these findings, a clinical study in 9 healthy human volunteers aged 25-35 years and weighing 50-75 kg was initiated. They were given 450 mg of rifampicin once only on day 1 and from the second day onwards were given 2 tablets of Diabecon (D-400) twice daily for 7 days. On day 9, another dose of rifampicin (450 mg) was given along with 2 tablets of Diabecon (D-400). Blood samples were collected at 2, 4, 6 and 8 h after drug administration on day 1 and day 9 to estimate the rifampicin levels in plasma. Interaction of Diabecon with nifedipine: In another study, 12 rabbits were divided into two groups of 6 each. Group I animals were treated with nifedipine (2.5 mg/kg body weight, p.o.) and Group II animals were treated with nifedipine (2.5 mg/kg body weight, p.o.) and Diabecon (D-400) (1 g/kg body weight, p.o.) for a period of 8 days. On day 1 and day 8, blood samples were collected at 1, 2, 4 and 6 h after drug administration and plasma nifedipine levels were estimated. The results of these three studies revealed that Diabecon (D-400) did not alter the pharmacokinetic profiles of rifampicin and nifedipine.
PMID: 10412895

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