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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Panacea Biotec Ltd
ClinicalTrials.gov Identifier:
NCT01041911
First received: December 31, 2009
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Hemorrhoids
Drug: Euphorbia tablets
Drug: Placebo tablets
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Panacea Biotec Ltd:

Primary Outcome Measures:
  • Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject [ Time Frame: 14 day of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects in each treatment group without recurrence of bleeding [ Time Frame: 14 days post treatment ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Euphorbia 50 mg
This arm subjects will be given 50 mg Euphorbia prostrata
Drug: Euphorbia tablets
50 mg, tablet, once daily, 14 days
Other Name: To be confirmed later
Active Comparator: Euphorbia 100 mg
In this arm subjects will be given 100 mg Euphorbia
Drug: Euphorbia tablets
100 mg, tablet, once daily, 14 days
Other Name: To be confirmed later
Active Comparator: Euphorbia 200 mg
In this arm subject will be given 200 mg Euphorbia tablets
Drug: Euphorbia tablets
200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
Other Name: To be confirmed later
Placebo Comparator: Placebo
In this arm subjects will be given placebo tablets
Drug: Placebo tablets
placebo, tablet, once daily, 14 days

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041911

Locations
India
Maulana Azad Medical College
New Delhi, Delhi, India, 110002
Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
New Delhi, Delhi, India, 110064
Bangalore Medical College
Bangalore, Karnakata, India, 560002
Grant Medical College
Mumbai, Maharashtra, India, 400008
Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane (W)
Thane, Maharashtra, India, 400601
Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank,
Thane, Maharashtra, India, 400601
Sponsors and Collaborators
Panacea Biotec Ltd
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Panacea Biotec Ltd
ClinicalTrials.gov Identifier: NCT01041911     History of Changes
Other Study ID Numbers: PBL/CR/0102008/CT
Study First Received: December 31, 2009
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Panacea Biotec Ltd:
Hemorrhoids

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014