A Prospective Open Labelled Non Randomized Phase-II Clinical Trial of “Kadukkai Chooranam for Akkini Selathumam (Diabetic Neuropathy)

Rajendram, Ajanthan (2019) A Prospective Open Labelled Non Randomized Phase-II Clinical Trial of “Kadukkai Chooranam for Akkini Selathumam (Diabetic Neuropathy). Masters thesis, Government Siddha Medical College, Palayamkottai.

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Abstract

Diabetes Mellitus is one of the most prevalent and serious metabolic diseases in the world which is predicted to increase dramatically. Diabetes is frequently associated with long term complications with macrovascular and microvascular origin. Diabetic neuropathy AKKINI SELATHUMAM) is one of the most common complications of diabetes mellitus. It is the most common neuropathy; it is estimated that about 50 percent of patients with diabetes mellitus will eventually develop some form of neuropathy. The study was aimed at evaluating clinical efficacy of the herbal formulation of KADUKKAI CHOORANAM (KC) on AKKINI SELATHUMAM in patients with type-II diabetes. This study is an open labelled non randomized Phase-II clinical trial spanning 90 days. About 40 subjects of age range between 40-70 years. In all 40 diabetic patients who were under treatment were randomly sampled for the study. Socio- demographic data were collected using predesigned questionnaires. Glycated haemoglobin levels, lipid profile, HBA1-C, fasting blood sugar and other haematological investigations were estimated using standard procedures before and after treatment. Diabetic Neuropathy was defined as per Use of the leeds assessment of neuropathic symptoms and signs pain scale. The Statistical analysis was done by SPSS statistical package version 20.0. Paired 2 tailed test revealed that the fasting (P<0.0001) and postprandial blood glucose (0.0001) and HbA1c (P<0.0001), in lipid profile TC (p<0.0001), LDL (p<0.0001), HDL (<0.0001) and TGL (p<0.0001) showed significant reduction after Kadukkai chooranam intervention. The liver, renal functions along with the haematological parameters were well within the normal range. The trial drug subjected to biochemical and pharmacological studies and gave significant results also. The results KC to be beneficial for the treatment of Akkini selathumam (Diabetic Neuropathy) in type-II diabetes; further follow-up studies are warranted to confirm the safety aspects of kadukkai Chooranam use.

Item Type: Thesis (Masters)
Additional Information: Reg.No.321611008
Uncontrolled Keywords: Prospective Open Labelled Non Randomized Phase-II Clinical Trial, Kadukkai Chooranam, Akkini Selathumam, Diabetic Neuropathy.
Subjects: AYUSH > Maruthuvam
Depositing User: Subramani R
Date Deposited: 03 Mar 2020 04:06
Last Modified: 03 Mar 2020 04:06
URI: http://repository-tnmgrmu.ac.in/id/eprint/11894

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