CTRI Number |
CTRI/2016/11/007499 [Registered on: 25/11/2016] Trial Registered Retrospectively |
Last Modified On: |
13/06/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Study of vitamin K2-7 (MK-7) in patients with tingling and numbness due to diabetes and / or vitamin B12 deficiency |
Scientific Title of Study
|
An Open labeled Multicentre Trial to compare the safety and efficacy of Vitamin K2-7 (MK-7) in patients with peripheral neuropathy due to type 2 diabetes mellitus and/ or megaloblastic anaemia |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
VBP–VITAMIN K2-7 (MK-7)-PN /15 Ver 1 dt 6/6/2015 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Vrinda Kulkarni |
Address |
Dr. A. L. Nair Road
Mumbai Central
Mumbai
Mumbai MAHARASHTRA 400008 India |
Phone |
02223027000 |
Fax |
|
Email |
kulkarnivrinda585@gmail.com |
|
Details Contact Person Scientific Query
|
Name |
Dr Yogesh Dound |
Address |
6/10
Jogani Industrial Complex
V. N. Purav Marg
Chunabhatti
Mumbai MAHARASHTRA 400022 India |
Phone |
02224055607 |
Fax |
|
Email |
yogesh_dound@yahoo.com |
|
Details Contact Person Public Query
|
Name |
Dr Yogesh Dound |
Address |
6/10
Jogani Industrial Complex
V. N. Purav Marg
Chunabhatti
Mumbai MAHARASHTRA 400022 India |
Phone |
02224055607 |
Fax |
|
Email |
yogesh_dound@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
Viridis BioPharma Pvt. Ltd.
6/10, Jogani Industrial Complex, V N Purav Marg, Chunabhatti. Mumbai 400 022 |
|
Primary Sponsor
|
Name |
Viridis BioPharma Pvt Ltd |
Address |
6/10, Jogani Industrial Complex, V.N. Purav Marg, Chunabhatti,
Mumbai – 400 022,
India |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 2 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Vrinda Kulkarni |
B Y L Nair Charitable Hospital |
Department of Haematology,
OPD No. 30,
OPD Building,
Dr. A. L. Nair Road,
Mumbai Central
Mumbai - 400008 Mumbai |
02223027000 02223072663 vrindaklr@yahoo.com |
Dr Milind Devale |
Kokan Hospital |
Areshwar Building,
1st Floor,
Mhada Colony,
Kokan Nagar,
Jogeshwari East,
Mumbai 400060 Mumbai |
02228374646
drshashank.jadhav@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Inter System BioMedica Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Neuropathy occuring because of Megaloblastic Anaemia, Type 2 Diabetes Mellitus |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
Vitamin K2-7 Capsules |
Each capsule of 100 mcg to be
given two times in a day orally after food for 8 weeks. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Male and female aged 18 to 65 who are suffering from type 2 diabetes mellitus and/ or megaloblastic anaemia.
2.Symptomatic diagnosis of neuropathy (>4 on VAS score).
3.Willing to give informed consent. |
|
ExclusionCriteria |
Details |
1.Patients who are suffering from any other systemic illness other than type 2 diabetes mellitus or megaloblastic anaemia.
2.Patients who are on corticosteroids and oral contraceptives
3.Patients with seropositive status.
4.Pregnancy
5.Patients Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
6.Patients who are on coumarin analogues
7.Patients who are on Quinine Hydrochloride
8.History of alcohol. substance abuse or alcoholism, within the previous one year |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
Outcome |
TimePoints |
The primary objective of the study is to evaluate the activity and tolerability of Vitamin K2-7 in patients with peripheral neuropathy. |
Activity and tolerability of vitamin MK-7 in patients of diabetes and Megaloblastic anaemia with peripheral neuropathy after 12 weeks of treatment. |
|
Secondary Outcome
Modification(s)
|
Outcome |
TimePoints |
Safety and tolerability; clinical and metabolic variables. |
The secondary objective will be sharply focused on the role of vitamin MK-7 in ameliorating the residual neuropathy symptoms after adequate correction of the underlying inciting event. A record will be maintained of some of the features such as hyper pigmentation, muscle cramps and fatigue for any effect of the intervention after 12 weeks of treatment |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
07/08/2015 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Brief Summary
|
Recent preliminary open labeled observational study
conducted by Vaidya et al shows that daily
oral dose of 100 mg
for 3 months is associated with a reduction in the frequency, intensity, and
duration of cramps. In an open labeled study conducted by Kulkarni et al, it was shown that vitamin K2-7 at
a dose of 100 mcg twice a day for 8 weeks was well tolerated and safe with a
therapeutic activity for the symptoms of peripheral neuropathy. Based on the results of these studies, the next study which is a follow up study in larger cohort is planned to address the peripheral neuropathy experienced by the patients. N=100 Evaluation parameters: Efficacy, tolerability and safety of Vitamin K2-7.
|