| CTRI Number |
CTRI/2023/05/052159 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Trumove Tablet in reducing Diabetic Nerve pain. |
|
Scientific Title of Study
|
A Randomized, Open Label, Comparative, Clinical Study To Evaluate The
Efficacy And Safety of Trumove Tablet In Patients With Diabetic
Neuropathic Pain
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TRUMOVETAB/04/23 version 1.0 Dated 19-03-2023. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Sakthi Balan MD |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Thirumalai medical Centre,ki3 |
| Address |
Room no. 1, Thirumalai medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Consultant Diabetologist and CI |
| Affiliation |
Thirumalai medical Centre, ki3 |
| Address |
Room no. 1, Thirumalai medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
CEO |
| Affiliation |
Ki3 |
| Address |
Room no.1, Ki3 Office, Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
kai3.mrg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tirupati Pharma, Ambala-Paonta Sahib-Dehradun Rd, Pataliyon, Himachal Pradesh 173021 |
|
|
Primary Sponsor
|
| Name |
Tirupati Pharma, India |
| Address |
AmbalaPaonta Sahib Dehradun Rd Pataliyon Himachal Pradesh 173021 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Sakthi Balan |
Thirumalai Medical Centre, Puducherry |
Room no.1, Thirumalai Medical Centre, No 408 Cuddalore Road Nainarmandapan Puducherry
Pondicherry
PONDICHERRY |
9443627722
saheerose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ki3 Ethics Committee for AYUSH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Trumove Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 150(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Pregabalin Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 75(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. Subject’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 β-Caryophyllene
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
|
| Outcome |
TimePoints |
Adverse events and serious adverse events during the study period
Brief clinical examination |
Baseline, week 4 & week 8 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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
|