A clinical comparative study of diabetic neuropathy using Vasantkusumakar Rasa and placebo.
- Conditions
- Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseasesHealth Condition 2: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2022/03/040803
- Lead Sponsor
- Department of Kayachikitsa College of Ayurved Bharati Vidyapeeth deemed to be University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)Controlled Type 2 Diabetes mellitus i.e., stable on Oral Hypoglycemic Agents or insulin.
2)HbA1c <= 7.5
3)Diabetic patient with clinical presentation of peripheral neuropathy.
4)Patients having DPN on the basis of Diabetic Neuropathy Symptom (DNS) score >=1, Diabetic Neuropathy Examination (DNE) score >= 3, abnormal monofilament test and abnormal VPT.
5)BP <= 160/90mmHg at both screening and baseline.
6)Patients willing for inclusion in clinical trial.
1)Any neurological condition requiring urgent medical intervention.
2)Any other serious systemic disease in last 3 months.
3)Patients having malignancies, serious infections as well as those requiring long term steroids and hormonal treatment.
4)Pregnant and lactating women.
5)Patients having H/O renal transplant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Reduction in symptoms of Diabetic Peripheral Neuropathy. <br/ ><br>2)Improvement in scores of TCSS. <br/ ><br>Timepoint: 3 months
- Secondary Outcome Measures
Name Time Method 1)Improvement in VPT demonstrated using a biothesiometer. <br/ ><br>2)Improvement in the visual analogue scale. <br/ ><br>3)Improvement in HbA1c.Timepoint: 3 months