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

December 4, 2012 updated by: Panacea Biotec Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110002
        • Maulana Azad Medical College
      • New Delhi, Delhi, India, 110064
        • Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
    • Karnakata
      • Bangalore, Karnakata, India, 560002
        • Bangalore Medical College
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Grant Medical College
      • Thane, Maharashtra, India, 400601
        • Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank,
      • Thane, Maharashtra, India, 400601
        • Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane (W)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • To be confirmed later
Drug: Euphorbia tablets
100 mg, tablet, once daily, 14 days
Other Names:
  • To be confirmed later
Drug: Euphorbia tablets
200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
Other Names:
  • To be confirmed later
Active Comparator: Euphorbia 100 mg
In this arm subjects will be given 100 mg Euphorbia
Drug: Euphorbia tablets
50 mg, tablet, once daily, 14 days
Other Names:
  • To be confirmed later
Drug: Euphorbia tablets
100 mg, tablet, once daily, 14 days
Other Names:
  • To be confirmed later
Drug: Euphorbia tablets
200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
Other Names:
  • To be confirmed later
Active Comparator: Euphorbia 200 mg
In this arm subject will be given 200 mg Euphorbia tablets
Drug: Euphorbia tablets
50 mg, tablet, once daily, 14 days
Other Names:
  • To be confirmed later
Drug: Euphorbia tablets
100 mg, tablet, once daily, 14 days
Other Names:
  • To be confirmed later
Drug: Euphorbia tablets
200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject
Time Frame: 14 day of treatment
14 day of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects in each treatment group without recurrence of bleeding
Time Frame: 14 days post treatment
14 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Panacea Biotec Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBL/CR/0102008/CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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