| CTRI Number |
CTRI/2011/12/002202 [Registered on: 05/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
26/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Extract of Euphorbia Prostrata in treatment of piles |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy and Tolerability of Euphorbia Prostrata Extract in treatment of first & second degree hemorrhoids |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PBL-TW/Piles/02-10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girish Bakshi |
| Designation |
Associate Professor Surgery |
| Affiliation |
Grant Medical College and Sir J J Group of hospitals |
| Address |
Department of surgery,
Grant Medical College and Sir J J Group of hospitals
Byculla
Mumbai
Byculla,
Mumbai-400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
gdbakhshi@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyadhar Desai |
| Designation |
General Manager- Medical Services |
| Affiliation |
Panacea Biotec Ltd. |
| Address |
Panacea Biotec Limited
7th floor, sagar tech plaza,A
sakinaka andheri(E).
Mumbai
7th floor, sagar tech plaza,A
sakinaka andheri(E).
Mumbai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
09322144771 |
| Fax |
|
| Email |
vidyadhardesai@PANACEABIOTEC.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyadhar Desai |
| Designation |
General Manager- Medical Services |
| Affiliation |
Panacea Biotec Ltd. |
| Address |
Panacea Biotec Limited
7th floor, sagar tech plaza,A
sakinaka andheri(E).
Mumbai
7th floor, sagar tech plaza,A
sakinaka andheri(E).
Mumbai
Mumbai
MAHARASHTRA
400072
India |
| Phone |
09322144771 |
| Fax |
|
| Email |
vidyadhardesai@PANACEABIOTEC.COM |
|
|
Source of Monetary or Material Support
|
| Panacea Biotec Limited
7th floor, sagar tech plaza,A
sakinaka andheri(E).
Mumbai |
|
|
Primary Sponsor
|
| Name |
Panacea Biotec Limited |
| Address |
7th floor, sagar tech plaza,A
sakinaka andheri(E).
Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish Bakshi |
Grant Medical College and Sir J J group of hospitals |
Department of general surgery
Byculla
Mumbai-400008
Mumbai
MAHARASHTRA |
09820218198
gdbakhshi@yahoo.com |
| Dr sandeep Kasabekar |
Sai Patik Surgical Clinic |
Bageshree,
Ground Floor, Plot No. 207,
Opp. Saraswat Bank, Sector-3,
Charkop, Kandivili (W) - 400 067
Mumbai
MAHARASHTRA |
09930003477
shailesh.joshi@clinsearch.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Grant Medical College |
Approved |
| league health independent ethics committee, Thane, Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
first degree external or internal heamorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet Pilex (Herbal combination)
Pilex Cream/Ointment
|
Two tablets orally two times daily with water for 14 days
cream to be applied locally at hemorrhoids two times daily and after each act of defecation for a period of 14 days.
|
| Intervention |
Tablet Two Weeks : Euphorbia Prostrata 100 mg
Two Weeks Cream/Ointment
|
One tablet orally once daily without regard to meal with water for 14 days
Cream to be applied locally at hemorrhoids two times daily and after each act of defecation for a period of 14 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with diagnosis of acute uncomplicated first degree external or internal hemorrhoids with active bleeding without infection and prolapse.
Provided written informed consent.
|
|
| ExclusionCriteria |
| Details |
Presence of infection of anorectal region.
Presence of other rectal pathology like anal fissure, rectal prolapse, ischiorectal abscess, anorectal fistula, or rectal polyp.
Subjects with known hepatic or kidney diseases.
Patients with known hypersensitivity to ingredients of study or comparator treatments
Clinically significant co-morbid condition other than bleeding piles that could directly affect the efficacy & tolerability outcome of the study.
Donated blood or plasma or participated in another clinical study with an investigational agent within 4 weeks preceding to enrollment.
H/O drug/alcohol abuse.
Pregnant and lactating women.
Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| rectal bleeding |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
rectal pain
rectal discharge
rectal irritation
need for rescue drug
Global assessments
|
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/08/2010 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Inclusión
Criteria:
Either gender between the age group
of 18 to 75 years.
Subjects with diagnosis of acute
uncomplicated first degree external or internal hemorrhoids with active
bleeding without infection and prolapse.
Provided written informed consent.
Exclusion
Criteria:
Presence of infection of anorectal
region.
Presence of other rectal pathology
like anal fissure, rectal prolapse, ischiorectal abscess, anorectal fistula, or
rectal polyp.
Subjects with known hepatic or
kidney diseases.
Patients with known hypersensitivity
to ingredients of study or comparator treatments
Clinically significant co-morbid
condition other than bleeding piles that could directly affect the efficacy
& tolerability outcome of the study.
Donated blood or plasma or
participated in another clinical study with an investigational agent within 4
weeks preceding to enrollment.
H/O drug/alcohol abuse.
Pregnant and lactating women.
Any other condition that, in the
opinion of the investigator, does not justify the inclusion of the subject in
the study.
|