Effect of Trumove Tablet in reducing Diabetic Nerve pain.

A Randomized, Open Label, Comparative, Clinical Study To Evaluate The Efficacy And Safety of Trumove Tablet In Patients With Diabetic Neuropathic Pain

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052159

Enrollment

Registered

2023-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Time to onset of relief of pain [ Time frame: in number of days] 2. Time to achieve complete relief of pain [ Time frame: in number of days] 3. VAS pain scores [ baseline, week 4 and week 8] 4. Nerve conduction study of foot to assess neuropathic pain and its grading [ baseline, week 4 and week 8] 5. Subjectâ??s overall satisfaction for pain relief on a 7- point Likert Satisfaction scale[Time Frame: Baseline, week 4 and week 8] 6.Number of patients requiring rescue medication [Time Frame: Up to week 8] 7.Changes from base line to 8 weeks in following laboratory parameter(s): C Reactive Protein ESR Plasma level of Î²-Caryophyllene 12. Changes from base line to 8 weeks postdose in Quality of life Questionnaires (Short Form Health-12). Timepoint: Baseline, week 4 & week 8	—

Measure

Time frame

1. Time to onset of relief of pain [ Time frame: in number of days] 2. Time to achieve complete relief of pain [ Time frame: in number of days] 3. VAS pain scores [ baseline, week 4 and week 8] 4. Nerve conduction study of foot to assess neuropathic pain and its grading [ baseline, week 4 and week 8] 5. Subjectâ??s overall satisfaction for pain relief on a 7- point Likert Satisfaction scale[Time Frame: Baseline, week 4 and week 8] 6.Number of patients requiring rescue medication [Time Frame: Up to week 8] 7.Changes from base line to 8 weeks in following laboratory parameter(s): C Reactive Protein ESR Plasma level of Î²-Caryophyllene 12. Changes from base line to 8 weeks postdose in Quality of life Questionnaires (Short Form Health-12). Timepoint: Baseline, week 4 & week 8

—

Secondary

Measure	Time frame
Adverse events and serious adverse events during the study period Brief clinical examinationTimepoint: Baseline, week 4 & week 8	—

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

Thirumalai medical Centre, ki3

saheerose@gmail.com9443627722

Outcome results