A study on Siddha Herboââ?¬â??Mineral Medicine Naaga chendooramfor the Diabetes Neurological complication(Madhumega Avathaigal)

Phase 2

Completed

• Conditions: Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

• Registration Number: CTRI/2021/07/035067
• Lead Sponsor: ational Institute of Siddha

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-02-29
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1.Blood sugar fasting >126 and <200 mg/dl or

Postprandial Blood Sugar >200 mg/dl and <350 mg /dl (or)

HbA1c >7% and <11% 2.Michigan Neuropathy Screening Instrument (MNSI) Examination score �2.5

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

1.Blood sugar fasting <126 and >200 mg/dl or

Postprandial Blood Sugar <200 mg/dl and >350 mg /dl (or)

HbA1c <7% and >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is assessed by comparing the blood sugar ,HbA1c level and diabetic peripheral neuropathy in pre and post treatment.Timepoint: 90 days

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be elucidate through study the In Vitro anti diabetic <br/ ><br>activity and mechanism of action of Naaga chendooram in alpha ââ?¬â??amylase inhibition <br/ ><br>assay and alpha glucosidase inhibition assay and The co-factors such as food habits, body constitution in Madhumegam, weight , <br/ ><br>height, Body mass index, occupation, income, socio-economic status etc will be <br/ ><br>studiedTimepoint: 90 days