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Clinical Trials/CTRI/2021/07/035067
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

ational Institute of Siddha0 sites80 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
February 29, 2016
Last Updated
3 years ago
Study Type
Interventional

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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