| 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
|
|
|
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
|
|
|
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
|
|
|
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. |