Health Condition 1: K00-K95- Diseases of the digestive system
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Males or females aged 18 to 75 years with grade 2 hemorrhoids. Subjects who have already taken corresponding treatment for grade-2 hemorrhoids. Willing to give written informed consent.
Exclusion criteria
Exclusion criteria: Subjects associated with anal fissure or infective anal pathologies, like cryptitis or proctitis were excluded. Subjects treated with some office procedure in the past were also excluded. Pregnant and lactating women were excluded. Subjects who were using other drugs or underwent any surgical procedures for hemorrhoids. Subjects with the history of any significant cardiac, gastro-intestinal, endocrine, neurological, liver, kidney or physiological disease were excluded. Drug or alcohol dependent. Patients who are under Antiplatelet and Anticoagulant drugs were excluded. Subjects participating in any other clinical trial or using any other investigational drug within 30 days prior to the screening were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Reduction in symptoms Improvement in pain bleeding prolapse and discomfort 2 Treatment success rate Percentage of patients achieving complete symptom relief 3 Recurrence rate Frequency of hemorrhoid recurrence within 6 months post-treatment 4 Adverse events Incidence of treatment related complications (eg pain swelling infection)Timepoint: 1 Reduction in symptoms Improvement in pain bleeding, prolapse and discomfort in 7th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Quality of life improvement Assessed using a validated hemorrhoid-specific questionnaire 2 Patient satisfaction score Based on treatment experience & symptom relief 3 Time to symptom relief Duration taken for significant symptom improvement post-treatment 4 Need for additional treatment Proportion of patients requiring retreatment or alternativeTimepoint: 1 Quality of life improvement in 14th day | — |
Countries
India
Contacts
SRM Medical College and Research Centre