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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euphorbia 50 mg | Active Comparator | This arm subjects will be given 50 mg Euphorbia prostrata |
|
| Euphorbia 100 mg | Active Comparator | In this arm subjects will be given 100 mg Euphorbia |
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| Euphorbia 200 mg | Active Comparator | In this arm subject will be given 200 mg Euphorbia tablets |
|
| Placebo | Placebo Comparator | In this arm subjects will be given placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euphorbia tablets | Drug | 50 mg, tablet, once daily, 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject | 14 day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in each treatment group without recurrence of bleeding | 14 days post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangalore Medical College | Bangalore | Karnakata | 560002 | India | ||
| Grant Medical College |
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| Euphorbia tablets | Drug | 100 mg, tablet, once daily, 14 days |
|
|
| Euphorbia tablets | Drug | 200 mg, tablet, 2 tablets of 100 mg Euphorbia prostrata, 14 days |
|
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| Placebo tablets | Drug | placebo, tablet, once daily, 14 days |
|
| Mumbai |
| Maharashtra |
| 400008 |
| India |
| Nath Hospital, Golden Heaven Society, Opp Janta Sahakari Bank, | Thane | Maharashtra | 400601 | India |
| Sahil Hospital, Tawdw Niwas, 1st Floor Khopat, Thane (W) | Thane | Maharashtra | 400601 | India |
| Maulana Azad Medical College | New Delhi | National Capital Territory of Delhi | 110002 | India |
| Deen Dayal Upadhyay Hospital, Hari Nagar, New Delhi | New Delhi | National Capital Territory of Delhi | 110064 | India |
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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