Effect of Trumove Tablet in reducing Diabetic Nerve pain.
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2023/05/052159
- Lead Sponsor
- Tirupati Pharma, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
3. Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent
voluntarily.
Patients who had been diagnosed with mild to moderate Diabetic Neuropathic Pain.
1. Women of child bearing potential who are either unwilling or
unable to use an acceptable method of birth control to avoid
pregnancy during the study period.
2. Subjects with Severe co morbid disease conditions like Heart
failure, Renal Failure or Liver failure.
3. Subject with history of uncontrolled diabetes (HbA1c > 10)
4. Known allergy to compounds of investigational product.
5. Participation in an investigational drug trial in the30 days
prior to the screeningvisit.
6. Patients of vulnerable group (children, lactating mother,
elderly >80 years,handicapped, seriously ill, mentally
challenged).
7. History of drug or alcohol abuse during the last 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Time to onset of relief of pain [ Time frame: in number of days] <br/ ><br>2. Time to achieve complete relief of pain [ Time frame: in number of days] <br/ ><br>3. VAS pain scores [ baseline, week 4 and week 8] <br/ ><br>4. Nerve conduction study of foot to assess neuropathic pain and its grading [ baseline, week 4 and week 8] <br/ ><br>5. Subjectâ??s overall satisfaction for pain relief on a 7- point Likert <br/ ><br>Satisfaction scale[Time Frame: Baseline, week 4 and week 8] <br/ ><br>6.Number of patients requiring rescue medication [Time Frame: Up to week 8] <br/ ><br>7.Changes from base line to 8 weeks in following laboratory <br/ ><br>parameter(s): <br/ ><br> C Reactive Protein <br/ ><br> ESR <br/ ><br> Plasma level of β-Caryophyllene <br/ ><br>12. Changes from base line to 8 weeks postdose in Quality of life Questionnaires (Short Form Health-12). <br/ ><br>Timepoint: Baseline, week 4 & week 8
- Secondary Outcome Measures
Name Time Method Adverse events and serious adverse events during the study period <br/ ><br>Brief clinical examinationTimepoint: Baseline, week 4 & week 8