A CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KSHEERABALA 101 AVARTHI AND KSHEERABALA THAILA IN THE MANAGEMENT OF DIABETIC PERIPHERAL NEUROPATHY
Not Applicable
Completed
- Conditions
- Health Condition 1: E104- Type 1 diabetes mellitus with neurological complicationsHealth Condition 2: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2021/12/038430
- Lead Sponsor
- Dr SHEMA SARA KURIE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1 METABOLICALLY STABLE DIABETIC SUBJECTS WITH SYMPTOMATIC DIABETIC PERIPHERAL NEUROPATHY
2 SUBJECTS OF ALL GENDER BETWEEN THE AGE GROUP OF 20-75 YEARS
3 SUBJECTS FULFILLING THE DIAGNOSTIC CRITERIA
4 SUBJECTS WHOSE HBA1C IS BETWEEN 6.5 TO 10%
Exclusion Criteria
1 SUBJECTS WHERE HBA1C >10%
2 SUBJECTS WITH OTHER CAUSES OF POLYNEUROPATHY OTHER THAN DIABETES
3 SUBJECTS SUFFERING FROM INFECTIOUS DISEASES AND NON-HEALING ULCER/ ULCERS OF FOOT
4 ANY SYSTEMIC ILLNESS THAT CAN INTERFERE WITH THE COURSE OF TREATMENT
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 CHANGES IN DIABETIC NEUROPATHY SYMPTOM (DNS) QUESTIONNAIRE SCORE <br/ ><br>2 CHANGES IN DIABETIC NEUROPATHY EXAMINATION (DNE)SCORE <br/ ><br>3 CHANGES IN VISUAL ANALOG SCALE <br/ ><br>Timepoint: 30TH DAY,45TH DAY
- Secondary Outcome Measures
Name Time Method CHANGES IN QUALITY OF LIFE <br/ ><br>(WHO QoL-BREF)Timepoint: 30th DAY