CTRI Number |
CTRI/2013/09/003998 [Registered on: 18/09/2013] Trial Registered Retrospectively |
Last Modified On: |
30/04/2021 |
Post Graduate Thesis |
No |
Type of Trial |
PMS |
Type of Study
Modification(s)
|
Nutraceutical |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
Modification(s)
|
An observational study of Vitamin K2-7 (MK-7) in patients with Muscle Cramps |
Scientific Title of Study
Modification(s)
|
An open labeled observational study of Vit K2-7(MK-7) in patients with Systremma (muscle cramps) |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
VBP – VITAMIN K2-7 (MK-7) /08 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rama Vaidya |
Address |
Sthanakwasi Jain Aradhana Dham,
17, K.D. Road,
Vile Parle (West)
Mumbai MAHARASHTRA 400056 India |
Phone |
022-26715147 |
Fax |
|
Email |
vaidya.rama@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 |
022-24055608 |
Fax |
022-24055952 |
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 |
022-24055608 |
Fax |
022-24055952 |
Email |
yogesh_dound@yahoo.com |
|
Source of Monetary or Material Support
|
Viridis BioPharma Pvt. Ltd. |
|
Primary Sponsor
|
Name |
Viridis BioPharma Pvt Ltd |
Address |
6/10, Jogani Induatrial Complex, V. N. Purav Marg, Chunabhatti. Mumbai 400 022 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Rama Vaidya |
Medical Research Center - Kasturba Health Society (MRC - KHS) |
Sthanakwasi Jain Aradhana Dham
17, K.D. Road
Vile Parle (W) Mumbai |
022-26246119
vaidya.rama@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Intersystem BioMedica Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
Disorders of muscle in diseases classified elsewhere |
Patients |
Idiopathic muscle cramps |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
No comparator agent |
No comparator agent |
Intervention |
Vitamin K2-7 |
Each capsule of 100 mcg to be given two times in a day orally for 3 months. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Inclusion criteria:
1. Men & women with idiopathic muscle cramps (cramp will be defined as a painful contraction of any muscle group in the leg, which was either precipitated by certain movements, aborted by
procedures involving stretch of the affected muscle or which was associated with a palpable
hardening of the muscle. To qualify for trial inclusion, subjects should have a stable pattern of two or more cramps per week for three months.
2. Willing to participate in the trial |
|
ExclusionCriteria |
Details |
Exclusion criteria:
1. Subjects with physiological conditions causing cramps like pregnancy or during sports activity
2. Patients with severe neurological, muscular, psychiatric, endocrinological, metabolic medical
conditions or vascular diseases, electrolyte imbalance, liver cirrhosis causing muscle cramps will be excluded
3. Subjects on drugs which are likely to affect muscle cramps
4. Subjects with any known hypersensitivity to Vitamin K
5. Patients with any cancers receiving chemotherapy/ radiation |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
The difference in number, duration and severity of cramps after treatment as compared to baseline |
4 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.The subject’s assessment of whether treatment was effective and any other change noticed in health
while on treatment
2.To assess any carry-over effect of the treatment |
4 months |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
17/11/2008 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Mehta DS, Vaidya RA, Dound YA et al. Therapeutic Activity and Safety of Vitamin K 2-7 in Muscle Cramps: An Interventional Case- Series. Journal of Indian Practitioner 2010 May: 287-291 |
Brief Summary
|
In this fixed dose (100μg/day), open labeled, ambulant study with variable compliance a distinct trend in relief of muscle cramps was observed. |