Health Condition 1: K641- Second degree hemorrhoids
Conditions
Interventions
Intervention1: SMUTH Capsule: Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg plus Docusate Sodium IP 100 mg
Dose One capsule TDS orally per day
Duration 35 days
Co
Sponsors
Aristo Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender between 18 and 65 years of age (inclusive of both). 2. Adult patients with 1 or 2 haemorrhoids diagnosed by clinical symptoms and anoscopy examination. 3. Haemorrhoids that bleed but do not prolapse outside the anal canal.
Exclusion criteria
Exclusion criteria: 1. Patients with 3 or 4 haemorrhoids, in whom the prolapse needed manual reduction or cannot be reduced. 2. Concurrent fistula or chronic anal fissure, inflammatory bowel disease, diabetes, coagulation disorders, abnormal sexual habits. 3. Previous anorectal surgery or previous treatment of haemorrhoid disease with any method other than diet modification and/or topical agents. 4. Clinically significant abnormalities on physical examination or laboratory tests. 5. Pregnant and lactating women. 6. Patients having known hypersensitivity to the study medications and/or ingredients in capsule. 7. Not willing to comply with the protocol requirements. 8. Non-suitability for enrollment otherwise as decided by investigator. 9. Patients having participated in any type of clinical study within the last three months of the screening date.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg plus Docusate Sodium IP 100 mg versus Dobesil500mg Capsule Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.Timepoint: Visit 1 Day 0 Baseline visit follow up at Visit 2 Day 7, Visit 3 Day 14, Visit 4 Day 21, Visit 5 Day 28 and Visit 6 Day 35 end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg Plus Docusate Sodium IP 100 mg versus Dobesil500mg Capsule Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.Timepoint: Visit 1 Day 0 Baseline visit follow up at Visit 2 Day 7, Visit 3 Day 14, Visit 4 Day 21, Visit 5 Day 28 & Visit 6 Day 35 end of study. | — |
Countries
India
Contacts
Public ContactDr Mahendra Chaudhari
Aristo Pharmaceuticals Private Limited
Outcome results
None listed