Health Condition 1: K649- Unspecified hemorrhoids
Conditions
Interventions
None listed
Sponsors
Sudhatatva Pharmacy
Eligibility
Inclusion criteria
Inclusion criteria: 1 Symptomatic primary hemorrhoids, Grades I-II by direct anoscopic visualization (anoscopic visualization not required if Grade determined by colonoscopy within 21 days prior to Day 1). 2 Bleeding from hemorrhoids for two consecutive days prior to randomization (Day 1). 3 The patient having Bleeding hemorrhoids, Pain in anal region due to piles complication (i.e. Inflammation, thrombosis), prolaps, itching, constipation two days prior to randomization (Day 1) will be selected for this clinical study. 4 For female patients cause of bleeding due to menses should be ruled out. 5 Able to attempt bowel movements daily (defined as trying to have a bowel movement while sitting on the toilet for at least a few minutes, at least once daily) 6 Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 7 Capable of and freely willing to provide written informed consent prior to participating in the study. 8 Signed informed consent prior to any study-mandated procedure. 9 Willing to comply with daily protocol.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in symptoms scores at endpoint as compared to baseline values in symptoms of Bleeding per rectum, Size of pile mass.Timepoint: Follow-up visits will be scheduled on the 7th, 15th, and 21st days after enrollment. A window period of 2 days will be allowed for each follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in symptoms scores at endpoint as compared to baseline values in symptoms of Protrusion of mass, Constipation, Tenderness, Pain.Timepoint: Follow up visits will be scheduled at 7th, 15th, & 21st days after enrollment. A window period of 2 days will be allowed for each follow up visit. | — |
Countries
India
Contacts
Public ContactDr Amit A Paliwal
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune
Outcome results
None listed