Effect of Trumove Tablet in reducing Diabetic Nerve pain.

Phase 3

Not yet recruiting

Conditions: Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Brief Summary: - The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.

- 30 Participants will be randomized into 2 groups with 15 in each group.

- Arm 1 - Trumove Tablet: 15 study participants

- Arm 2 - Pregabalin Tablet: 15 study participants

Recruitment & Eligibility

Inclusion Criteria

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

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.
Subjects with Severe co morbid disease conditions like Heart failure, Renal Failure or Liver failure.
Subject with history of uncontrolled diabetes (HbA1c > 10) 4.
Known allergy to compounds of investigational product.
Participation in an investigational drug trial in the30 days prior to the screeningvisit.
Patients of vulnerable group (children, lactating mother, elderly >80 years,handicapped, seriously ill, mentally challenged).
History of drug or alcohol abuse during the last 6 months.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events and serious adverse events during the study period	Brief clinical examination

Locations (1): Thirumalai Medical Centre, Puducherry
🇮🇳
Pondicherry, PONDICHERRY, India
Thirumalai Medical Centre, Puducherry
🇮🇳Pondicherry, PONDICHERRY, India
Dr M Sakthi Balan
Principal investigator
9443627722
saheerose@gmail.com