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CTRI Number  CTRI/2018/05/013701 [Registered on: 04/05/2018] Trial Registered Prospectively
Last Modified On: 03/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Heparin sodium topical solution 1000 IU/ ml in the treatment of thrombophlebitis associated with varicose vein 
Scientific Title of Study   This will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, interventional study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amarinder Singh 
Designation  General Manager 
Affiliation  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone  07926856242  
Fax    
Email  amarindersingh@troikaapharma.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amarinder Singh 
Designation  General Manager 
Affiliation  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone  07926856242  
Fax    
Email  amarindersingh@troikaapharma.com  
 
Details of Contact Person
Public Query
 
Name  Pratik Shah 
Designation  Project Manager 
Affiliation  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev

Ahmadabad
GUJARAT
380054
India 
Phone  07926856242  
Fax    
Email  pratikshah@troikaapharma.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Troikaa Pharmaceuticals Limited 
Address  Troikaa Pharmaceuticals Limited Commerce House 1 Satya marg bodakdev Ahmedabad  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anshuman Darbari  AIIMS Rishikesh Uttrakhand  pashulok rishikesh

 
001352462514
01352462940
darbarianshu@gmail.com 
Dr V Balaji  Apollo Hospital  # 21 greams road
Chennai
TAMIL NADU 
04428296785
04428296785
jveebalaji@yahoo.co.in 
Dr Dheepak Selvaraj  Christian Medical College and hospital   IDA Scudder Road Sripuram
Vellore
TAMIL NADU 
04162282085
04162282085
drdevdeepak2000@yahoo.com 
Dr Rajesh Hyderabadi  Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre  Adani Arogyadham dr J M road Vasna
Ahmadabad
GUJARAT 
07926639840
0792660141
research@jivrajhealthcare.org 
Dr Subhendu Sekhar Mahapatra  IPGMER and SSKM Hospital  244 AJC Bose road
Kolkata
WEST BENGAL 
9433283336

apurasm@yahoo.co.in 
Dr Surendra Agarwal  SGPGI Medical Sciences  raibareilly road
Lucknow
UTTAR PRADESH 
05222494208
05222494208
surendra2000_in@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Institute Ethics Committe AIIMS Rishikesh  Submittted/Under Review 
Institute Ethics committe of Jivraj mehta hospital  Approved 
Institute Ethics Committee CMC Vellore  Submittted/Under Review 
Institute Ethics Committee SGPGI Bioethics cell  Submittted/Under Review 
Institutional Ethics Committee Clinical Studies Apollo Hospital  Submittted/Under Review 
IPGME&R Research Oversight Committee SSKM Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of unilateral varicose veins-leg Having SVT in affected superficial veins confined to varicosities without any DVT ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Heparin Sodium 1000 IU/ ml  Each ml of topical solution contains 1000 IU equivalent heparin sodium Dose 1000 IU/ml Route Topical Frequency three times a day Total Duration treatment period of 14 days 
Comparator Agent  PLacebo  Placebo matching Heparin topical solution Dose 1000 IU/ml Route Topical Frequency three times a day Total Duration treatment period of 14 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Presenting with area of thrombophlebitis having tenderness erythema pain and swelling overlying the affected superficial vein
Having SVT in affected superficial veins confined to varicosities without any DVT as confirmed at screening by Duplex USG
Willing & able to comply with study requirements eg regular application of IP/wear elastic stocking and efficacy-safety evaluation schedule as indicated by written informed consent provided by the patient
2 If female of childbearing potential non-pregnant supported by negative urine pregnancy test at screening non-lactating and willing to maintain reliable birth control throughout the study
 
 
ExclusionCriteria 
Details  1 Multiple superficial vein thrombosis that require LMWH therapy
2 Bilateral varicose veins-leg
3 Suppuration or other indications of infection
4 Open wound/ breach of skin
5 Hospitalization or long confinement to bed
6 Recent within last 6 months history of thromboembolic event eg Pulmonary embolism deep vein thrombosis superficial thrombophlebitis treated surgically
7 Recent within last 6 months history of cancer or its treatment
8 Hepatic impairment SGPT/SGOT > 3 times ULN or renal impairment creatinine > 2 mg/dL
9 Patient with history of CKD or CKD confirmed by decrease in GFR<60 ml/min/1.73 m2 present for >3 months
10 Known hypersensitivity to heparin or history of heparin-induced thrombocytopenia
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Each group of test arm will be compared to other two groups of test arm as well as to corresponding group in placebo arm for Median reduction in thrombus length
 
NA 
 
Secondary Outcome  
Outcome  TimePoints 
Median change in severity of tenderness measured by 4-point scale
Mean change in erythema area cm2 measured by manual planimetry Investigator will demarcate the area with erythema on transparent sheet and the area will be calculated in cm2 using graph paper
Median change in pain intensity measured by NRS
Median change in severity of swelling measured by 4-point scale
Mean number of times rescue drug applied over treatment period
Mean number of days with rescue drug application

 
NA 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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 2/ Phase 3 
Date of First Enrollment (India)   25/06/2018 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Varicose veins is a common superficial pathology that leads to serious complications like ulceration and irritating symptoms such as pain, pruritus, swelling, erythema etc. resulting in morbidity in large population. Unfractionated heparin and low molecular heparin have been the corner stone of conservative management of the symptoms of varicose veins. Some European published studies indicate that liposomal heparin spray gel, a topical heparin sodium product was effective in reducing symptoms of varicose thrombophlebitis and are also reported to reduce size of thrombus in varicose veins.

Based on this information Troikaa proposes the present  study to identify effectiveness and safety of their marketed product heparin sodium topical solution (1000 IU/ ml) as add on therapy to SOC in the treatment of thrombophlebitis associated with varicose vein

 
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