Extract of Euphorbia Prostrata in treatment of piles

Phase 4

Completed

Brief Summary: **InclusiÃ³nCriteria**:

Either gender between the age groupof 18 to 75 years.

Subjects with diagnosis of acuteuncomplicated first degree external or internal hemorrhoids with activebleeding without infection and prolapse.

Provided written informed consent.

**ExclusionCriteria**:

Presence of infection of anorectalregion.

Presence of other rectal pathologylike anal fissure, rectal prolapse, ischiorectal abscess, anorectal fistula, orrectal polyp.

Subjects with known hepatic orkidney diseases.

Patients with known hypersensitivityto ingredients of study or comparator treatments

Clinically significant co-morbidcondition other than bleeding piles that could directly affect the efficacy& tolerability outcome of the study.

Donated blood or plasma orparticipated in another clinical study with an investigational agent within 4weeks preceding to enrollment.

H/O drug/alcohol abuse.

Pregnant and lactating women.

Any other condition that, in theopinion of the investigator, does not justify the inclusion of the subject inthe study.

Recruitment & Eligibility

Inclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
rectal bleeding	14 days

Secondary Outcome Measures

Name	Time	Method
rectal pain	rectal discharge

Locations (2): Grant Medical College and Sir J J group of hospitals
🇮🇳
Mumbai, MAHARASHTRA, India
Sai Patik Surgical Clinic
🇮🇳
Mumbai, MAHARASHTRA, India
Grant Medical College and Sir J J group of hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Dr Girish Bakshi
Principal investigator
09820218198
gdbakhshi@yahoo.com