| CTRI Number |
CTRI/2021/12/038604 [Registered on: 14/12/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety of sitcom forte tablet and sitcom cream in treatment of varicose veins |
|
Scientific Title of Study
|
Study to evaluate the efficacy and safety of sitcom forte tablet euphorbia prostrata 100 mg and calcium dobesilate 500 mg and sitcom cream euphorbia prostrata dry extract Cream in treatment of varicose veins |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HHCRS/Varicose/002/20-21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwin Porwal |
| Designation |
Principal Investigator |
| Affiliation |
Healing Hands Clinic |
| Address |
4th floor,Millenium star extension adjcent to ruby hall dhole patil road pune 01
Pune
MAHARASHTRA
411001
India |
| Phone |
9822347770 |
| Fax |
|
| Email |
drashwinporwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin Porwal |
| Designation |
Principal Investigator |
| Affiliation |
Healing Hands Clinic |
| Address |
4th floor,Millenium star extension adjcent to ruby hall dhole patil road pune 01
Pune
MAHARASHTRA
411001
India |
| Phone |
9822347770 |
| Fax |
|
| Email |
drashwinporwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin Porwal |
| Designation |
Principal Investigator |
| Affiliation |
Healing Hands Clinic |
| Address |
4th floor,Millenium star extension adjcent to ruby hall dhole patil road pune 01
Pune
MAHARASHTRA
411001
India |
| Phone |
9822347770 |
| Fax |
|
| Email |
drashwinporwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panacea biotec pharma ltd
710 7th floor sagartech plaza mumbai 400072 |
|
|
Primary Sponsor
|
| Name |
Healing Hands Clinic |
| Address |
Millenium star extension adjcent to ruby hall dhole patil road pune |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sangram Indore |
Dhanawantari Multispeciality hospital |
2nd floor Sai sanskruti baif Rd wagholi maharashtra 412207.
Pune
MAHARASHTRA |
9890820867
sangram.indore@yahoo.com |
| Dr Ashwin Porwal |
Healing Hands Clinic |
4th floor,Millenium star extension adjcent to ruby hall dhole patil road pune
Pune
MAHARASHTRA |
9822347770
drashwinporwal@gmail.com |
| Dr Vijay Pawar |
Pawar Hospital |
2nd floor shatanand complex next to pearl tower near pmt bus depot gadital hadapsar pune maharashtra 411028.
Pune
MAHARASHTRA |
9422210434
drvijayp@hotmail.com |
| Dr Nachiket Purandhare |
Purandhare Hospital |
972 subhash nagar shukrawar peth pune maharashtra 411042.
Pune
MAHARASHTRA |
9822171301
purandare.nachiket@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Healing Hands IEC |
Approved |
| Healing Hands IEC |
Approved |
| Healing Hands IEC |
Approved |
| Healing Hands IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I832||Varicose veins of lower extremities with both ulcer and inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Sitcom cream |
To be applied locally with standard dressing at affected area least twice daily for 3 months. |
| Intervention |
Sitcom Forte Tablet |
1 tablet Twice Daily for 1 month.
1 tablet Once a day or Twice Daily for 2 months (As per clinical condition).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient is diagnosed with primary or symptomatic varicose veins and not indicated for any surgical intervention.
2.Patients is willing to participate in the current study and sign the informed consent form.
3.Patients is not on any other allopathic / herbal medication (oral or topical) for the treatment of varicose veins for last 7 days.
|
|
| ExclusionCriteria |
| Details |
1.Lactating women. Women in post –partum period of up to 6 weeks.
2.Patient having hypersensitive predisposition or hypersensitive to any of components of the study drug.
3.Clinically significant co-morbid condition that in the opinion of the investigator could affect patient.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in VVSymQ scores for symptoms (Pain in Legs, Swelling, Tingling, Numbness in legs and itching around veins).
2.Change in skin color.
3.Change in number and size of venous ulcers
4.Decrease in rate of Occlusion
5.Venous ulcer reduction
6.Venous Stasis changes
7.Overall Improvement in Disease (By Investigator and Patient)
8.Treatment Assessment (By Investigator and Patient)
|
2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Number of Adverse Events during the study duration |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/12/2021 |
| Date of Study Completion (India) |
13/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subjects having varicose veins and found to be eligible as
per inclusion-exclusion criteria would be enrolled in the study after informed
consent signed. Total 100 patients will be enrolled in this study.Each subject will be followed up for 3
months. The protocol specified
visits would be as Visit 1- Baseline, Visit 2 - End of 1 month, Visit 3 - End
of 2 month, Visit 4 - End of 3 month. Each visit subsequent to enrollment, will
allow for 2 additional days to attend the protocol specified clinic visit. If subject discontinues from the study
medication on or before visit 2 (either drop out or due to any adverse drug
reaction) then visit 2 will be considered as the study completion visit and no
activities listed for the visit 3 will be performed. Subject will be
instructed to report at study site for any SAE observed within 30 days of study
completion.Investigator/designee will enter the subject’s data
in the respective Case Report Form (CRF). In case any observation at any
specified time point in not done or data is unavailable then the same should be
documented as not done (ND) in the CRF.The study would be conducted in accordance with the
protocol for the study approved by the concerned Ethics Committee, and any
amendments to the said protocol that the Ethics Committee may approve from time
to time. The investigator will take all trial related medical decisions at the
site. This includes the medical care provided for inter-current illnesses or
any adverse events.
|