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

NCT01041911 | Completed Phase 2

• 1 other identifier: PBL/CR/0102008/CT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

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.

Conditions

Hemorrhoids

Keywords

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject

  14 day of treatment

Secondary Outcomes (1)

• Proportion of subjects in each treatment group without recurrence of bleeding

  14 days post treatment

Study Arms (4)

Euphorbia 50 mg

ACTIVE COMPARATOR

This arm subjects will be given 50 mg Euphorbia prostrata

Drug: Euphorbia tablets

Euphorbia 100 mg

ACTIVE COMPARATOR

In this arm subjects will be given 100 mg Euphorbia

Drug: Euphorbia tablets

Euphorbia 200 mg

ACTIVE COMPARATOR

In this arm subject will be given 200 mg Euphorbia tablets

Drug: Euphorbia tablets

Placebo

PLACEBO COMPARATOR

In this arm subjects will be given placebo tablets

Drug: Placebo tablets

Interventions

Euphorbia tablets DRUG

50 mg, tablet, once daily, 14 days

Also known as: To be confirmed later

Euphorbia 50 mg

Placebo tablets DRUG

placebo, tablet, once daily, 14 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Panacea Biotec Ltd: lead

Study Sites (6)

Bangalore Medical College

Bangalore, Karnakata, 560002, India

Location

Grant Medical College

Mumbai, Maharashtra, 400008, India

Location

Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank,

Thane, Maharashtra, 400601, India

Location

Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane (W)

Thane, Maharashtra, 400601, India

Location

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, 110002, India

Location

Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi

New Delhi, National Capital Territory of Delhi, 110064, India

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dr P N Agarwal

  Maulana Azad Medical College, New Delhi

  PRINCIPAL INVESTIGATOR

• Dr Girish Bakshi

  Grant Medical College, Mumbai

  PRINCIPAL INVESTIGATOR

• Dr T Durganna

  Bangalore Medical College, Bangalore

  PRINCIPAL INVESTIGATOR

• Dr Saiprasad Donga

  Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane

  PRINCIPAL INVESTIGATOR

• Dr Vaibhav Lokhande

  Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank, Khopat, Thane

  PRINCIPAL INVESTIGATOR

• Dr P S Sarangi

  Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2009
• First Posted: January 1, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

IN (6)