HemorrhoidsPhase 2NCT01041911
To Evaluate the Dose Response of 3 Doses of Euphorbia Prostrata in Patients With First and Second Degree Hemorrhoids
A Phase 2 study testing Euphorbia tablets in people with Hemorrhoids, run by Panacea Biotec Ltd at 6 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Euphorbia tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 6 sitesIndia
- Study dates
- Mar 2010to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Bangalore Medical College
Bangalore, Karnakata, 560002
Grant Medical College
Mumbai, Maharashtra, 400008
Maulana Azad Medical College
New Delhi, National Capital Territory of Delhi, 110002
Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
New Delhi, National Capital Territory of Delhi, 110064
Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank,
Thane, Maharashtra, 400601
Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane (W)
Thane, Maharashtra, 400601
About this study
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
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.
Read the 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.
- Conditions
- Hemorrhoids
- Being tested
- Euphorbia tablets, Placebo tablets
- Keywords
- Hemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Euphorbia tabletsDrug
Also called To be confirmed later
50 mg, tablet, once daily, 14 days
Euphorbia tabletsDrug
Also called To be confirmed later
100 mg, tablet, once daily, 14 days
Euphorbia tabletsDrug
Also called To be confirmed later
200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days
Placebo tabletsDrug
placebo, tablet, once daily, 14 days
| Study group | Role | What they receive |
|---|---|---|
| Euphorbia 50 mg | Active comparator | This arm subjects will be given 50 mg Euphorbia prostrata Receives: Drug: Euphorbia tablets |
| Euphorbia 100 mg | Active comparator | In this arm subjects will be given 100 mg Euphorbia Receives: Drug: Euphorbia tablets |
| Euphorbia 200 mg | Active comparator | In this arm subject will be given 200 mg Euphorbia tablets Receives: Drug: Euphorbia tablets |
| Placebo | Placebo comparator | In this arm subjects will be given placebo tablets Receives: Drug: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject
Measured: 14 day of treatment
Secondary outcomes (1)
Proportion of subjects in each treatment group without recurrence of bleeding
Measured: 14 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panacea Biotec Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr P N Agarwal, Principal investigator, Maulana Azad Medical College, New DelhiDr Girish Bakshi, Principal investigator, Grant Medical College, MumbaiDr T Durganna, Principal investigator, Bangalore Medical College, BangaloreDr Saiprasad Donga, Principal investigator, Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, ThaneDr Vaibhav Lokhande, Principal investigator, Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank, Khopat, ThaneDr P S Sarangi, Principal investigator, Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041911
- Sponsor's protocol ID
- PBL/CR/0102008/CT
- Status last verified
- Dec 2012
- First submitted
- 31 Dec 2009
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01041911
- Acronym / sponsor ID
- PBL/CR/0102008/CT
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Panacea Biotec LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 1 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Euphorbia 50 mg | Active comparator | Drug: Euphorbia tabletsThis arm subjects will be given 50 mg Euphorbia prostrata |
| Euphorbia 100 mg | Active comparator | Drug: Euphorbia tabletsIn this arm subjects will be given 100 mg Euphorbia |
| Euphorbia 200 mg | Active comparator | Drug: Euphorbia tabletsIn this arm subject will be given 200 mg Euphorbia tablets |
| Placebo | Placebo comparator | Drug: Placebo tabletsIn this arm subjects will be given placebo tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Euphorbia tabletsAlso: To be confirmed later50 mg, tablet, once daily, 14 days | Drug | Euphorbia 50 mg |
| Euphorbia tabletsAlso: To be confirmed later100 mg, tablet, once daily, 14 days | Drug | Euphorbia 100 mg |
| Euphorbia tabletsAlso: To be confirmed later200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days | Drug | Euphorbia 200 mg |
| Placebo tabletsplacebo, tablet, once daily, 14 days | Drug | Placebo |
Primary outcome
Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject
Time frame: 14 day of treatment
1 secondary outcome
Proportion of subjects in each treatment group without recurrence of bleeding
Time frame: 14 days post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr P N Agarwal principal investigator
Maulana Azad Medical College, New Delhi
Dr Girish Bakshi principal investigator
Grant Medical College, Mumbai
Dr T Durganna principal investigator
Bangalore Medical College, Bangalore
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Euphorbia tablets in people with Hemorrhoids, run by Panacea Biotec Ltd at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject (time frame: 14 day of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.