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CTRI Number  CTRI/2014/07/004728 [Registered on: 11/07/2014] Trial Registered Prospectively
Last Modified On: 09/05/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the effect of a patch on blood circulation.  
Scientific Title of Study   An exploratory, open label, single arm study to assess the effect of Patch It® on blood circulation. 
Trial Acronym  Circupatch 
Secondary IDs if Any  
Secondary ID  Identifier 
NW/120907/P-It/BC Version 1.0 Date 22/August/2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajiv Parakh 
Designation  Principal Investigator 
Affiliation  Medanta – The Medicity 
Address  Division of Peripheral Vascular and Endovascular Sciences, Medanta – The Medicity, Sector – 38.
NA
Gurgaon
HARYANA
122001
India 
Phone  91-1244141414  
Fax    
Email  rajiv.parakh@medanta.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Navneet Sonawane 
Designation  Manager Clinical Operations 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd B 118, Morya House, Off New Link Road Andheri West.
NA
Mumbai
MAHARASHTRA
400053
India 
Phone  02242025706  
Fax    
Email  navneet.s@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Navneet Sonawane 
Designation  Manager Clinical Operations 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd B 118, Morya House, Off New Link Road Andheri West.
NA
Mumbai
MAHARASHTRA
400053
India 
Phone  02242025706  
Fax    
Email  navneet.s@vediclifesciences.com  
 
Source of Monetary or Material Support  
Medanta - The Medicity 
 
Primary Sponsor  
Name  Vedic Lifesciences Pvt Ltd 
Address  B 118, Morya House, Off New Link Road, Andheri West, Mumbai 400053, India. 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
Vedic Lifesciences Pvt Ltd  B 118, Morya House, Off New Link Road, Andheri West, Mumbai 400053, India. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Krishan Sharma  Medanta - The Medicity  Division of Peripheral Vascular & Endovascular Sciences, Medanta – The Medicity, Sector – 38, Gurgaon, Haryana – 122 001.
Gurgaon
HARYANA 		 91-1244141414

krishan.sharma@medanta.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Blood Circulation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  None 
Intervention  Patch It  Patch It is a rectangular patch meant for application on the soles over the arches of the feet at night for 7-8 hours for 2 weeks. Its active ingredients include mandarin wood vinegar, green tea and tourmaline which are believed to improve circulation and bring about detoxification thus providing relief from aches, pain and swelling and promoting sleep. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  • Patients capable of giving informed consent to participate in the study of their own free will.
• Ankle-brachial index of <1.0 but ≥ 0.50 at rest in at least one leg
• Arterial doppler of common femoral artery - Biphasic waveform, peak systolic velocities (PSV) distal/PSV proximal ratio < 2:1 and less than 50% stenosis 
 
ExclusionCriteria 
Details  • Patients with clinical evidence of varicose veins and with history or a pre-disposition for deep vein thrombosis
• Patients with absent arterial pulsations in the lower limb
• Patients with ulcerative lesions on the foot that would interfere with the application of the patch
• Patients with history of severe claudication
• Ankle brachial index < 0.5 which is suggestive of severe arterial occlusive disease.
• Any cardiac, hepatic, renal, hemopoietic disease, endocrinal or other systemic disease which in the opinion of the Investigator is not suitable for the study
• Patients using vasodilators, diuretics, low sodium salt and/or potassium salt as determined by history or previous reports of the patient
• Female patients who are pregnant, or lactating, or who plan to become pregnant
• Known hypersensitivity or allergy to one or more of the ingredients of the Investigational Product ( IP)
• Patients otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the study
• Patients with clinically significant abnormal laboratory readings done at the screening visit like Complete blood count (CBC), Erythrocyte sedimentation rate (ESR), Serum glutamic pyruvic transaminase (SGPT), Serum Creatinine (Sr. Creatinine), Urine Routine(UR)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine changes in the TCPO2 levels after the application of patch.  Day 0, Day 1 and Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/07/2014 
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="2"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Patch-It is made up of Mandarin wood vinegar, green tea powder and black Tourmaline. Mandarin wood vinegar (MWV) generates an energy (assumed to be Far Infrared) that when applied to reflexology points on the base of the foot results in improved whole body circulation. Tourmaline has unique properties associated with healing and is widely used as a source of far infrared energy. Green tea is made with the leaves of Camellia sinensis which is known to possess beneficial impact on vascular function. Green tea is high in polyphenols and has been added to the patch as an antioxidant to provide added protection to the skin.

Due to the above mentioned properties of the ingredients in Patch-It it is employed in the current study to demonstrate its effects on blood circulation. Transcutaneous oxygen tension (TCPO2) assessment will be conducted to determine the changes in tissue perfusion. 

 
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