Health Condition 1: O224- Hemorrhoids in pregnancy
Conditions
Interventions
Intervention1: Sitcom tablet: 100mg tablet Once Daily for 14 days.
Intervention2: Sitcom cream: To be applied locally at least twice daily and after each act of defecation for 14 days.
Control Interve
Sponsors
Healing Hands Clinic
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pregnant Female patient, at least 18 years of age with a complaint of hemorrhoids during pregnancy. 2.Patient is willing to participate in the current study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Lactating women. Women in post –partum period of up to 6 weeks. 2.Patient having hypersensitive predisposition or hypersensitive to any of components of the study drug 3.Clinically significant co-morbid condition that in the opinion of the investigator could affect patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Cessation of per rectal bleeding 2.Relief from pain at defecation 3.Relief from Itching, exudation and swelling 4.Re-treatment initiation required during study duration 5.Overall improvement in disease condition (assessed by Patients and Physicians) V3 End of 2 week 6.For Hemorrhoids Overall improvement in disease condition assessed by Patients 7.Overall improvement in disease condition assessed by Physician Timepoint: 4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of Adverse Events during the study duration.Timepoint: 2 months | — |
Countries
India
Contacts
Public ContactDr Ashwin Porwal
Healing Hands Clinic
Outcome results
None listed