To Evaluate the Dose Response of 3 Doses of Euphorbia Prostrata in Patients With First and Second Degree Hemorrhoids

Hemorrhoids Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled, Dose Response Study to Evaluate the Safety and Efficacy of Three Doses of Euphorbia Prostrata Dry Extract Tablets in Patients of Hemorrhoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041911
• Other study ID #: PBL/CR/0102008/CT
• Status: Completed
• Phase: Phase 2
• First received: December 31, 2009
• Last updated: December 4, 2012
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2012
• Source: Panacea Biotec Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safe and efficacious dose of Euphorbia prostrata for control of per rectal bleeding in patients with first and second degree hemorrhoids.

Description:

Hemorrhoidal disease is a common entity in the general population and in clinical practice. The basic pathological factor in hemorrhoids is the dilation of the anorectal venous plexuses. In the acute bleeding of internal hemorrhoids, one of the pathogenic processes implicated is the stagnation and stasis of blood in the vascular plexuses of the prolapsed anal cushions. Euphorbia prostrata extract is found to have antihemorrhoidal activity and is useful in ameliorating signs and symptoms associated with hemorrhoids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult subjects who are able to understand nature, significance and scope of the clinical trial and express their will accordingly and agreeing to participate in the study by giving written informed consent.

• Male or female subjects, at least 18 years of age with a diagnosis of internal hemorrhoids (first and second degree) confirmed by proctoscopic examination and suffering from an uncomplicated and untreated acute attack (defined as acute onset of per rectal bleeding within 3 days of inclusion into the study, with at least one of the symptoms viz. pain, tenesmus, pruritus and anal discharge).

• Except internal hemorrhoids (first and second degree), the subjects are judged to be in good general health, based on medical history, physical examination, and laboratory screening tests.

Exclusion Criteria:

• Pregnant and lactating women and women in post-partum period of up to 6 weeks.

• Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.

• Subjects who have been previously enrolled in a study involving E. prostrata Dry Extract

• Subjects with a history of permanent anal prolapse and/or anal fistula

• Subjects with associated anal fissures and/or infective anal pathology.

• Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photocoagulation, cryotherapy etc) within 2 year of enrolment into the trial.

• Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.

• Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study.

• Subjects with clinically significant laboratory values for hemoglobin, total leukocyte count, differential count, bleeding time, clotting time, PT/INR, aPTT/control, platelet count, SGOT, SGPT, alkaline phosphatase, total bilirubin, random blood sugar, serum cholesterol, blood urea, serum creatinine and urine routine and microscopic examination.

• Treatment with any of the following at inclusion or in the previous one month venotropic, anticoagulant, and anti platelet agent. Subjects on aspirin up to 160 mg for cardiovascular indication will not be excluded from the trial.

• Treatment with any of the following at inclusion or in the previous one week anti-inflammatory and analgesic agent.

• Other chronic medications not being used at a stable dosage for at least 2 weeks.

• Subjects who are current users of illicit drugs including "recreational use" or with a history of drug abuse within the past 5 years.

• Subjects who have donated a unit of blood or plasma or participated in another clinical study with an investigational agent within the last 12 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Drug:
• Euphorbia tablets
50 mg, tablet, once daily, 14 days
• Euphorbia tablets
100 mg, tablet, once daily, 14 days
• Euphorbia tablets
200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
• Placebo tablets
placebo, tablet, once daily, 14 days

Locations

Country	Name	City	State
India	Bangalore Medical College	Bangalore	Karnakata
India	Grant Medical College	Mumbai	Maharashtra
India	Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi	New Delhi	Delhi
India	Maulana Azad Medical College	New Delhi	Delhi
India	Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank,	Thane	Maharashtra
India	Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane (W)	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Panacea Biotec Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject		14 day of treatment	No
Secondary	Proportion of subjects in each treatment group without recurrence of bleeding		14 days post treatment	No