Clinical trial NCT01041911: To Evaluate the Dose Response of 3 Doses of Euphorbia Prostrata in Patients With First and Second Degree Hemorrhoids
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemorrhoids
Keywords: Hemorrhoids
Lead sponsor: Panacea Biotec Ltd
Sponsor class: INDUSTRY
First posted: 2010-01-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject
timeFrame: 14 day of treatment
Secondary outcomes:
measure: Proportion of subjects in each treatment group without recurrence of bleeding
timeFrame: 14 days post treatment
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Azad Medical College
state: Delhi
city: New Delhi
country: India
facility: Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
state: Delhi
city: Bangalore
country: India
facility: Bangalore Medical College
state: Karnakata
city: Mumbai
country: India
facility: Grant Medical College
state: Maharashtra
city: Thane
country: India
facility: Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank,
state: Maharashtra
city: Thane
country: India
facility: Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane (W)
state: Maharashtra
Study officials:
affiliation: Maulana Azad Medical College, New Delhi
name: Dr P N Agarwal
role: PRINCIPAL_INVESTIGATOR
affiliation: Grant Medical College, Mumbai
name: Dr Girish Bakshi
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangalore Medical College, Bangalore
name: Dr T Durganna
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane
name: Dr Saiprasad Donga
role: PRINCIPAL_INVESTIGATOR
affiliation: Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank, Khopat, Thane
name: Dr Vaibhav Lokhande
role: PRINCIPAL_INVESTIGATOR
affiliation: Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
name: Dr P S Sarangi
role: PRINCIPAL_INVESTIGATOR
References: