Efficacy and tolerability of Dianex in type 2 diabetes mellitus: A non randomized, open label non-coqmparative study

V. Sudha, K. L. Bairy, U. Shashikiran, A. Sachidananda, B. Jayaprakash, S. Shalini

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objective and study design: A nonrandomized open labeled clinical trial to evaluate the efficacy and tolerability of Dianex (a poly herbal formulation developed by Apex Laboratories [PVT] Chennai, Tamil Nadu, India) in type 2 diabetes mellitus was carried out during a 6-month period. Settings/location: This study was conducted in TMA Pai Hospital, Udupi, South India. Subjects: A total of 40 patients were recruited for this study. Three patients dropped out of the study leaving a total of 37 patients (11 for monotherapy and 26 for add on therapy). Outcome measures: Eighteen (18) clinical variables were investigated, including liver enzymes, kidney function tests, hematologic parameters, blood glucose, and insulin and lipid profiles. Results: at the end of 12 weeks it was found that there was a significant decrease in the level of glycated hemoglobin, fasting plasma insulin level, insulin resistance, and systolic and diastolic blood pressure. At the end of 24 weeks results were similar to those at 12 weeks. Dianex did not alter the liver function tests, hematological parameters, or kidney function tests. Conclusion: In this preliminary study, Dainex is found to be an effective adjuvant drug with either oral antidiabetic agents or insulin that can be used in the control of blood sugars in diabetic patients. Dianex is a safe drug that does not cause any clinical, hematological or biochemical alteration in major organ systems.

Original languageEnglish
Pages (from-to)204-211
Number of pages8
JournalMedical Journal of Malaysia
Volume60
Issue number2
Publication statusPublished - 01-12-2005

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Type 2 Diabetes Mellitus
Kidney Function Tests
Insulin
Blood Glucose
India
Blood Pressure
Liver Function Tests
Glycosylated Hemoglobin A
Hypoglycemic Agents
Pharmaceutical Preparations
Insulin Resistance
Fasting
Outcome Assessment (Health Care)
Clinical Trials
Lipids
Liver
Enzymes
Therapeutics

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Sudha, V. ; Bairy, K. L. ; Shashikiran, U. ; Sachidananda, A. ; Jayaprakash, B. ; Shalini, S. / Efficacy and tolerability of Dianex in type 2 diabetes mellitus : A non randomized, open label non-coqmparative study. In: Medical Journal of Malaysia. 2005 ; Vol. 60, No. 2. pp. 204-211.
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Sudha, V, Bairy, KL, Shashikiran, U, Sachidananda, A, Jayaprakash, B & Shalini, S 2005, 'Efficacy and tolerability of Dianex in type 2 diabetes mellitus: A non randomized, open label non-coqmparative study', Medical Journal of Malaysia, vol. 60, no. 2, pp. 204-211.

Efficacy and tolerability of Dianex in type 2 diabetes mellitus : A non randomized, open label non-coqmparative study. / Sudha, V.; Bairy, K. L.; Shashikiran, U.; Sachidananda, A.; Jayaprakash, B.; Shalini, S.

In: Medical Journal of Malaysia, Vol. 60, No. 2, 01.12.2005, p. 204-211.

Research output: Contribution to journalArticle

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T1 - Efficacy and tolerability of Dianex in type 2 diabetes mellitus

T2 - A non randomized, open label non-coqmparative study

AU - Sudha, V.

AU - Bairy, K. L.

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AU - Sachidananda, A.

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AU - Shalini, S.

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N2 - Objective and study design: A nonrandomized open labeled clinical trial to evaluate the efficacy and tolerability of Dianex (a poly herbal formulation developed by Apex Laboratories [PVT] Chennai, Tamil Nadu, India) in type 2 diabetes mellitus was carried out during a 6-month period. Settings/location: This study was conducted in TMA Pai Hospital, Udupi, South India. Subjects: A total of 40 patients were recruited for this study. Three patients dropped out of the study leaving a total of 37 patients (11 for monotherapy and 26 for add on therapy). Outcome measures: Eighteen (18) clinical variables were investigated, including liver enzymes, kidney function tests, hematologic parameters, blood glucose, and insulin and lipid profiles. Results: at the end of 12 weeks it was found that there was a significant decrease in the level of glycated hemoglobin, fasting plasma insulin level, insulin resistance, and systolic and diastolic blood pressure. At the end of 24 weeks results were similar to those at 12 weeks. Dianex did not alter the liver function tests, hematological parameters, or kidney function tests. Conclusion: In this preliminary study, Dainex is found to be an effective adjuvant drug with either oral antidiabetic agents or insulin that can be used in the control of blood sugars in diabetic patients. Dianex is a safe drug that does not cause any clinical, hematological or biochemical alteration in major organ systems.

AB - Objective and study design: A nonrandomized open labeled clinical trial to evaluate the efficacy and tolerability of Dianex (a poly herbal formulation developed by Apex Laboratories [PVT] Chennai, Tamil Nadu, India) in type 2 diabetes mellitus was carried out during a 6-month period. Settings/location: This study was conducted in TMA Pai Hospital, Udupi, South India. Subjects: A total of 40 patients were recruited for this study. Three patients dropped out of the study leaving a total of 37 patients (11 for monotherapy and 26 for add on therapy). Outcome measures: Eighteen (18) clinical variables were investigated, including liver enzymes, kidney function tests, hematologic parameters, blood glucose, and insulin and lipid profiles. Results: at the end of 12 weeks it was found that there was a significant decrease in the level of glycated hemoglobin, fasting plasma insulin level, insulin resistance, and systolic and diastolic blood pressure. At the end of 24 weeks results were similar to those at 12 weeks. Dianex did not alter the liver function tests, hematological parameters, or kidney function tests. Conclusion: In this preliminary study, Dainex is found to be an effective adjuvant drug with either oral antidiabetic agents or insulin that can be used in the control of blood sugars in diabetic patients. Dianex is a safe drug that does not cause any clinical, hematological or biochemical alteration in major organ systems.

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