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

Primary Purpose

Hemorrhoids

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Euphorbia tablets

Placebo tablets

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring Hemorrhoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Euphorbia 50 mg

Euphorbia 100 mg

Euphorbia 200 mg

Placebo

Arm Description

This arm subjects will be given 50 mg Euphorbia prostrata

In this arm subjects will be given 100 mg Euphorbia

In this arm subject will be given 200 mg Euphorbia tablets

In this arm subjects will be given placebo tablets

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of subjects in each treatment group without recurrence of bleeding

Full Information

NCT ID

NCT01041911

First Posted

December 31, 2009

Last Updated

December 4, 2012

Sponsor

Panacea Biotec Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01041911

Brief Title

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

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Panacea Biotec Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoids

Keywords

Hemorrhoids

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Euphorbia 50 mg

Arm Type

Active Comparator

Arm Description

This arm subjects will be given 50 mg Euphorbia prostrata

Arm Title

Euphorbia 100 mg

Arm Type

Active Comparator

Arm Description

In this arm subjects will be given 100 mg Euphorbia

Arm Title

Euphorbia 200 mg

Arm Type

Active Comparator

Arm Description

In this arm subject will be given 200 mg Euphorbia tablets

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

In this arm subjects will be given placebo tablets

Intervention Type

Drug

Intervention Name(s)

Euphorbia tablets

Other Intervention Name(s)

To be confirmed later

Intervention Description

50 mg, tablet, once daily, 14 days

Intervention Type

Drug

Intervention Name(s)

Euphorbia tablets

Other Intervention Name(s)

To be confirmed later

Intervention Description

100 mg, tablet, once daily, 14 days

Intervention Type

Drug

Intervention Name(s)

Euphorbia tablets

Other Intervention Name(s)

To be confirmed later

Intervention Description

200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo tablets

Intervention Description

placebo, tablet, once daily, 14 days

Primary Outcome Measure Information:

Title

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

Time Frame

14 day of treatment

Secondary Outcome Measure Information:

Title

Proportion of subjects in each treatment group without recurrence of bleeding

Time Frame

14 days post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: