| CTRI Number |
CTRI/2020/04/024684 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
14/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of vitamin K2-7 in Osteoporosis |
|
Scientific Title of Study
|
An open labelled trial to study the safety and efficacy of Vitamin K2-7 in Human Osteoporosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No. SSV-K2-09/2019, Version 1 dated 26 Aug 2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Chaudhari |
| Designation |
Consulting Orthopedist |
| Affiliation |
Vakratund Hospital |
| Address |
Department of Orthopaedics Prashant Nagar, Near Sales Tax Office Road, Pathardi Phata, Mumbai Agra Highway
Nashik
MAHARASHTRA
422010
India |
| Phone |
|
| Fax |
|
| Email |
akhil.vakratund@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhil Chaudhari |
| Designation |
Consulting Orthopedist |
| Affiliation |
Vakratund Hospital |
| Address |
Department of Orthopaedics Prashant Nagar, Near Sales Tax Office Road, Pathardi Phata, Mumbai Agra Highway
MAHARASHTRA
422010
India |
| Phone |
|
| Fax |
|
| Email |
akhil.vakratund@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhil Chaudhari |
| Designation |
Consulting Orthopedist |
| Affiliation |
Vakratund Hospital |
| Address |
Department of Orthopaedics Prashant Nagar, Near Sales Tax Office Road, Pathardi Phata, Mumbai Agra Highway
MAHARASHTRA
422010
India |
| Phone |
|
| Fax |
|
| Email |
akhil.vakratund@gmail.com |
|
|
Source of Monetary or Material Support
|
| SSV Phytopharmaceuticals 201/2, Old Kashmiri Bldg Majas Wadi, Jogeshwari Mumbai 400 060 |
|
|
Primary Sponsor
|
| Name |
SSV Phytopharmaceuticals |
| Address |
201/2, Old Kashmiri Bldg Majas Wadi, Jogeshwari Mumbai 400 060 |
| 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 Akhil Chaudhari |
Vakratund Hospital |
Department of Orthopaedics, Prashant Nagar, Near Sales Tax Office Road, Pathardi Phata, Mumbai Agra Highway
Nashik
MAHARASHTRA |
02532386001
akhil.vakratund@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Navsanjeevani Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Vitamin K2-7 |
100 mcg capsule twice a day after lunch and dinner for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Men and non-pregnant women who are at least 20 years and under 75 years of age; and
2.The osteoporosis diagnosed by standard DXA measurement (BMD T-score: - 2.5 or below); and
3.Pain defined by a level of greater than or equal to 4 on Visual Analogue Scale (VAS).
4. Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and
5.Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication. |
|
| ExclusionCriteria |
| Details |
1.Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
2.Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
3.Recent myocardial infarction (within the prior 12 weeks).
4.Unstable angina pectoris.
5.Known or suspected renal insufficiency defined as creatinine>1.5mg/dl.
6.Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l).
7.Known hypomotility syndrome: (such as hypothyroidism or scleroderma).
8.Recent major trauma within the prior 12 weeks.
9.Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
10.Recent hospitalization (within 12 weeks) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain Score on the basis of Visual Analog Scale (VAS) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and Efficacy |
30 days |
|
|
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)
|
16/04/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL. Publication which arise directly out of this trial results |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The objective of the study is to investigate efficacy and safety of Vitamin K2-7 in the management of pain due to Osteoporosis. Primary outcome- Reduction in Pain Score on the basis of Visual Analog Scale (VAS) within 30 days Secondary outcome: Safety, Efficacy and Tolerability
N= 30 Osteocalcin Measurement (ucOC and COC) in 10 patients will be done at baseline and at the end of the study. |