Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: NAAGA CHENDOORAM: Dosage:488 Milligrams,Adjuvant:Thirikadhukugu chooranam and honey,Rout of administartion:oral ,Frequency:Twice a day before meal ,Duration of therapy :90 days
Control
Sponsors
National Institute of Siddha
Eligibility
Inclusion criteria
Inclusion criteria: 1.Blood sugar fasting >126 and Postprandial Blood Sugar >200 mg/dl and HbA1c >7% and considered positive for neuropathy total score out of 5 and MNSI Questionnaires . score �7 considered positive for presence of neuropathy total score out of 15.3.Patients who is already under siddha medication for Madhumegam 4.Already diagnosed DM patients with or without clinical symptom.5.symptoms of polyurea,polydipsia ,Nocturia ,Polyphagia ,Body pain ,Weight loss, Tiredness ,Burning feet & palm Genital pruritus Patients who fulfill any of the above four clinical symptoms will be included in the clinical trial.
Exclusion criteria
Exclusion criteria: 1.Blood sugar fasting 200 mg/dl or Postprandial Blood Sugar 350 mg /dl (or) HbA1c 11% 2.IDDM (Insulin Dependent Diabetes Mellitus) Secondary Hypertension ,Secondary Diabetes Mellitus,Coronary double vessel & triple vessel disease Pregnant woman and planning to be pregnant within three months,Lactating mother,Central nervous disorder,Gestational Diabetes Mellitus,Existing renal failure indicated by elevated serum creatinine levels,Subjects those who are not willing to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is assessed by comparing the blood sugar ,HbA1c level and diabetic peripheral neuropathy in pre and post treatment.Timepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome will be elucidate through study the In Vitro anti diabetic activity and mechanism of action of Naaga chendooram in alpha ââ?¬â??amylase inhibition assay and alpha glucosidase inhibition assay and The co-factors such as food habits, body constitution in Madhumegam, weight , height, Body mass index, occupation, income, socio-economic status etc will be studiedTimepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr K VIGNESH KUMAR
National Institute of Siddha
Outcome results
None listed