| CTRI Number |
CTRI/2022/03/041503 [Registered on: 30/03/2022] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical Study of Vitamin K2-7 capsules in Subjects with tingling and numbness due to diabetes |
|
Scientific Title of Study
|
An Open Label, Single Arm, Study to Assess the Efficacy and Safety of Menaquinone-7 (Vitamin K2-7) in Subjects with Diabetic Peripheral Neuropathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-SYN-002 Version 1.0 Dated 15 Feb 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish H Sarwate |
| Designation |
Principal Investigator |
| Affiliation |
Shivam Polyclinic |
| Address |
2nd Floor Pradhan Building, Above Mango Showroom,
Gokhale Road, Naupada, Thane- west
Thane
MAHARASHTRA
400602
India |
| Phone |
9324508128 |
| Fax |
|
| Email |
ashish.sarwate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction, Thane west
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank S Jadhav |
| Designation |
Medical Director |
| Affiliation |
Synergia Life Sciences Pvt. Ltd |
| Address |
Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai,
Maharashtra 400071, India
Mumbai
MAHARASHTRA
400071
India |
| Phone |
02262669600 |
| Fax |
|
| Email |
shashank@synergialifesciences.com |
|
|
Source of Monetary or Material Support
|
| Synergia Life Sciences Pvt. Ltd.
1503, Universal Majestic, P. L. Lokhande Marg,
Ghatkopar - Mankhurd Link Road,
Govandi, Mumbai - 400 043,
INDIA. |
|
|
Primary Sponsor
|
| Name |
Synergia Life Sciences Pvt Ltd |
| Address |
1503, Universal Majestic, P. L. Lokhande Marg,
Ghatkopar - Mankhurd Link Road,
Govandi, Mumbai - 400 043,
INDIA. |
| 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 |
| DrAshish H Sarwate |
Shivam Polyclinic |
2nd Floor Pradhan Building, Above Mango Showroom, Gokhale Road, Naupada, Thane- west,Maharashtra
400602
India
Thane
MAHARASHTRA |
9324508128
ashish.sarwate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| V Care Independent Ethics Committee, |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Menaquinone-7 (Vitamin K2-7) Capsules, |
One capsule two times per day orally for 8 Weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or Female subjects with age 18 to 65 years of age( both inclusive)
2. Subjects with known case of Type 2 Diabetes Mellitus (on regular and stable medication from last 3 months).
3. Subjects presenting with symptoms of impaired peripheral neuropathy defined by bilateral decreased or absent reflexes at the ankles, or bilateral decreased vibration, pinprick, fine touch or temperature perception in the distal lower extremities; and confirmed by nerve conduction velocity (NCV) studies.
4. Subjects with symptomatic diagnosis of peripheral neuropathy with pain severity score of (>4 on VAS score).
5. Subjects who are willing to sign informed consent for participation in |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of diabetic foot ulcers (Wagner Grade ≥1) or lower extremity amputation, diabetic amyotrophy, or non-diabetic cause of lower limb neuropathy
2. Any condition that may lead to confusion of the diagnostic of painful DPN, in particular amputations other than fingers/toes-, not diabetic neurological disorder and skin conditions that may affect sensation at the painful limbs.
3. Subjects who are unable to discontinue prohibited medications or non-drug therapies or procedures throughout the duration of the study
4. Subjects who are on corticosteroids and oral contraceptives within 2 weeks of screening visit 5. Subjects who are on coumarin analogues or Quinine Hydrochloride within 2 weeks of screening visit
6. Subjects with Hepatic impairment defined as Serum Bilirubin, SGOT or SGPT > 2 x upper limit of normal (ULN)
7. Subjects with impaired renal function defined as either serum creatinine level > 2 mg/dL or requiring hemodialysis
8. Subjects with uncontrolled hypertension at screening (sitting systolic >160 mmHg and/or sitting diastolic >90 mmHg
9. Subjects with current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s)
10. Subjects with Congestive heart failure Class III or IV of the New York Heart Association (NYHA) 11. Subjects with serious or unstable coronary heart disease, hepatic, kidney, respiratory, hematological alterations, problems with peripheral vascular disease, or other medical or psychiatric conditions that can put in risk the participation of the subject in the study.
12. Subjects with Glycosylated haemoglobin (HbA1c) greater than (≥) 10 percent at screening
13. Subjects with history of hypersensitivity to the drugs in the study or drugs with similar chemical structures
14. Subjects with arthritis, sciatic, fibromyalgia, restless leg syndrome, non-neuropathic muscle-skeletal pain or back chronic pain
15. Subjects who are Pregnant or Breast feeding. 16. Subjects with history of alcohol. substance abuse or alcoholism, within the previous one year
17. Subjects Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Summed change in sensory NCV from baseline of the bilateral sural , proximal and distal median sensory nerves |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in VAS scale as assessed from the baseline to end of the study. |
8 Weeks |
| Change from baseline in the individual NCVs. |
8 Weeks |
| Change from baseline in the individual nerve amplitudes. |
8 Weeks |
| Change from baseline in the individual nerve latency. |
8 Weeks |
| Change from baseline in the serum Osteocalcin (cOC and ucOC) levels. |
8 weeks |
| Change from baseline in the serum Vitamin K2-7 levels. |
8 weeks |
| The assessment of safety of Investigational Product will be based on the frequency of Adverse Events. |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is an Open Label, Single Arm, Study to Assess the Efficacy and Safety of Menaquinone-7 (Vitamin K2-7) in Subjects with Diabetic Peripheral Neuropathy
The objectives of the study are to evaluate the Efficacy and Safety of Menaquinone-7 (Vitamin K2-7) in patients with Diabetic Peripheral Neuropathy.
Primary Endpoints: - Summed change in sensory NCV from baseline of the bilateral sural , proximal and distal median sensory nerves Secondary Endpoints: - Change in VAS scale as assessed from the baseline to end of the study. - Change from baseline in the individual NCVs. - Change from baseline in the individual nerve amplitudes. - Change from baseline in the individual nerve latency. - Change from baseline in the serum Osteocalcin (cOC and ucOC) levels. - Change from baseline in the serum Vitamin K2-7 levels. Safety End Point: - The assessment of safety of Investigational Product will be based on the frequency of Adverse Events |