CLINICAL TRIAL ONPALSINURON CAPSULE FOR TREATMENT OF DIABETIC NEUROPATHY
Phase 4
- Conditions
- Health Condition 1: null- Patients of Type II Diabetes Mellitus diagnosed with diabetic peripheral sensorimotor neuropathy
- Registration Number
- CTRI/2017/07/009087
- Lead Sponsor
- Ms SG Phyto Pharma Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Metabolically stable diabetic patients with symptomatic diabetic sensorimotor polyneuropathy (DSPN)
2.Patients of either sex between the age group of 35-65 years.
3. HbA1c not exceeding 11
Exclusion Criteria
1.Patients who are insulin dependent.
2.Patients with other metabolic and endocrinal disorders.
3.Patients with other causes of Polyneuropathy.
4.Patients suffering from infectious diseases.
5.Patients with non healing ulcer/ulcers.
6.Patients with Diabetic Polyneuropathy in stage N3 of Dyckâ??s staging
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Changes in Neuropathy Symptom Score (NSS) and <br/ ><br>â?¢Michigan Neuropathy Screening Instrument (MNSI). <br/ ><br>â?¢Quality of Life; WHO QoL (BREF) <br/ ><br>Timepoint: Baseline and at the end of 3 months
- Secondary Outcome Measures
Name Time Method Quality of Life; WHO QoL (BREF)Timepoint: Baseline and at the end of 3 months