| CTRI Number |
CTRI/2021/12/039010 [Registered on: 29/12/2021] 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 study the effectiveness of sitcom tablet and sitcom cream in haemorrhoids during pregnancy |
|
Scientific Title of Study
|
Study to evaluate the efficacy and safety of sitcom tablet (euphorbia prostrata dry Extract 100 mg) and sitcom cream (euphorbia prostrata dry Extract cream) in treatment of haemorrhoids during pregnancy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HHCRS/HAEM/V-1/003/20-21 |
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 adjacent to ruby hall dhole patil road pune
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 adjacent to ruby hall dhole patil road pune
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 adjacent to ruby hall dhole patil road pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9822347770 |
| Fax |
|
| Email |
drashwinporwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panacea Biotec Pharma Ltd
708-718,7th floor sagartech plaza A wing sakinaka junction andheri mumbai 400072 |
|
|
Primary Sponsor
|
| Name |
Healing Hands Clinic |
| Address |
Millenium star extension adjacent 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| 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 Ashwin Porwal |
Healing Hands Clinic |
1st floor crystal empire building opposite hotel sadanand next to amar business park baner road pune maharashtra 411045
Pune
MAHARASHTRA |
9822347770
drashwinporwal@gmail.com |
| Dr Ashwin Porwal |
Healing Hands Clinic |
Second floor premier plaza near big bazar and big cinema above mac donald chinchwad pune 411019
Pune
MAHARASHTRA |
9822347770
drashwinporwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| 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: O224||Hemorrhoids in pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Sitcom cream |
To be applied locally at least twice daily and after each act of defecation for 14 days. |
| Intervention |
Sitcom tablet |
100mg tablet Once Daily for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant Female patient, at least 18 years of age with a complaint of hemorrhoids during pregnancy.
2.Patient is willing to participate in the current study and sign the informed consent form.
|
|
| 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.Cessation of per rectal bleeding
2.Relief from pain at defecation
3.Relief from Itching, exudation and swelling
4.Re-treatment initiation required during study duration
5.Overall improvement in disease condition (assessed by Patients and Physicians) V3 End of 2 week
6.For Hemorrhoids Overall improvement in disease condition assessed by Patients
7.Overall improvement in disease condition assessed by Physician
|
4 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Number of Adverse Events during the study duration. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2022 |
| 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="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
|
Pregnant females having hemorroids, anal
region pain and found to be eligible as per inclusion-exclusion criteria
would be enrolled in the study after signing informed consent.Approximately 100 subjects will be enrolled in this study.Each patient will be followed up for 2 months after treatment and 1
month post-delivery. The protocol
specified visits would be as Visit 1- Baseline, Visit 2 - End of 1 week, Visit 3
- End of 2 week, Visit 4 - End of 4 week, Visit 5 - End of 2 months Visit 6 -
End of 1 month Post-Delivery. Each visit subsequent to enrollment,will allow
for 2 additional days to attend the protocol specified clinic visit. If patient 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. Patient will be instructed to report at study
site for any SAE observed within 30 days of study completion.Investigator/designee will enter the patient’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
study site. This includes the medical care provided for inter-current illnesses
or any adverse events.
|