CTRI/2021/07/035067
Completed
Phase 2
A Randomized control trial on the therapeutic effect of Siddha Herboââ?¬â??Mineral preparation Naaga Chendooram in the treatment of Madhumega Avathai vii - (Diabetic Peripheral Neuropathy)- a complication of Non -Insulin -Dependent (type ii) Dibetes Mellitus. - NCDP
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Sponsor
- ational Institute of Siddha
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 ââ?°Â¥2\.5
- •considered positive for neuropathy total score out of 5 and MNSI Questionnaires .
- •score ââ?°Â¥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
Outcomes
Primary Outcomes
Not specified
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