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

NCT ID: NCT01041911

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-11-30

Brief Summary

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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

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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.

Conditions

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Hemorrhoids

Keywords

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Euphorbia 50 mg

This arm subjects will be given 50 mg Euphorbia prostrata

Group Type ACTIVE_COMPARATOR

Euphorbia tablets

Intervention Type DRUG

50 mg, tablet, once daily, 14 days

Euphorbia 100 mg

In this arm subjects will be given 100 mg Euphorbia

Group Type ACTIVE_COMPARATOR

Euphorbia tablets

Intervention Type DRUG

100 mg, tablet, once daily, 14 days

Euphorbia 200 mg

In this arm subject will be given 200 mg Euphorbia tablets

Group Type ACTIVE_COMPARATOR

Euphorbia tablets

Intervention Type DRUG

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

Placebo

In this arm subjects will be given placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DRUG

placebo, tablet, once daily, 14 days

Interventions

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Euphorbia tablets

50 mg, tablet, once daily, 14 days

Intervention Type DRUG

Euphorbia tablets

100 mg, tablet, once daily, 14 days

Intervention Type DRUG

Euphorbia tablets

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

Intervention Type DRUG

Placebo tablets

placebo, tablet, once daily, 14 days

Intervention Type DRUG

Other Intervention Names

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To be confirmed later To be confirmed later To be confirmed later

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Panacea Biotec Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr P N Agarwal

Role: PRINCIPAL_INVESTIGATOR

Maulana Azad Medical College, New Delhi

Dr Girish Bakshi

Role: PRINCIPAL_INVESTIGATOR

Grant Medical College, Mumbai

Dr T Durganna

Role: PRINCIPAL_INVESTIGATOR

Bangalore Medical College, Bangalore

Dr Saiprasad Donga

Role: PRINCIPAL_INVESTIGATOR

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

Dr Vaibhav Lokhande

Role: PRINCIPAL_INVESTIGATOR

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

Dr P S Sarangi

Role: PRINCIPAL_INVESTIGATOR

Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi

Locations

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Bangalore Medical College

Bangalore, Karnakata, India

Site Status

Grant Medical College

Mumbai, Maharashtra, India

Site Status

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

Thāne, Maharashtra, India

Site Status

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

Thāne, Maharashtra, India

Site Status

Maulana Azad Medical College

New Delhi, National Capital Territory of Delhi, India

Site Status

Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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PBL/CR/0102008/CT

Identifier Type: -

Identifier Source: org_study_id