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A PRE-CLINICAL EFFICACY AND RANDOMIZED CONTROLLED CLINICAL TRIAL OF NEELKANTHI CHURNA IN THE MANAGEMENT OF TYPE 2 DIABETES MELLITUS
Shivali Mehra*, Vijay Chaudhary, Anjana Mishra and Yogendra S. Padwad
Ethnopharmacological relevance: Neelkanthi (Ajuga bracteosa) is a folklore medicine occurring in Western Himalayas. This plant has also been used traditionally in local areas for curing a number of diseases including Diabetes Mellitus. No antidiabetic action of Neelkanthi has been mentioned in Ayurvedic texts, but by virtue of its properties it acts as Madhumehahara Aushada. Hence the present study has been planned to assess the efficacy of Neelkanthi Churna in the management of Madhumeha w.s.r. to Type 2 Diabetes Mellitus on scientific lines. Aim of the study: The present study was carried out to investigate the effect of Neelkanthi Churna (NC) in a mice model of Diabetes Mellitus. Further, its clinical safety and efficacy was assessed in a randomized active-controlled clinical study. Materials and methods: In pre-clinical study, the mice in different groups were kept on high-fat diet for 16 weeks. Thereafter, the mice were treated with 610 and 1220 mg/kg of the NC preparation for subsequent 4 weeks. At the end, different biochemical and histopathological parameters of the NC treated groups were compared with disease control groups. In the clinical trial, 45 patients were randomly divided into following three groups: GROUP I: 15 Patients were managed with NC 3gm twice/day for 12 weeks. GROUP II: 15 Patients were managed with Tab. Metformin 1gm twice/day for 12 weeks. GROUP III: 15 Patients were given both Tab. Metformin 1gm twice/day and NC 3gm twice/day for 12 weeks. At the baseline and endpoint, serum biochemical and haematological parameters were studied. Results: In preclinical experiment, a significant dose-dependent decrease in the Fasting Blood Sugar, total serum cholesterol, triglycerides, low-density lipoprotein (LDL), and increase in high-density lipoprotein (HDL) was observed in NC-treated group compared to disease control. In clinical study, NC significantly decreased the levels of FBS, PPBS, HbA1c and urine sugar following treatment compared to the baseline. However, insignificant change was observed in the studied parameters among NC and Tab. Metformin at the end of the treatment. The other studied biochemical and haematological parameters remained unchanged in all groups following the treatment compared to the baseline. Conclusions: The results of pre-clinical and clinical studies supported the efficacy of NC in Type 2 Diabetes Mellitus. The study also suggested the clinical safety of the NC preparation.[Full Text Article]