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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

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