A multi-centre study to compare and evaluate a herbal capsule in patients with hemorrhoids
Phase 4
Completed
- Conditions
- Health Condition 1: K649- Unspecified hemorrhoids
- Registration Number
- CTRI/2017/10/010038
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
1.Patients of either gender, aged >=18 years, with hemorrhoids confirmed by proctoscopy
2.Patients able to give signed informed consent before examination.
Exclusion Criteria
1.Hypersensitivity to any of the ingredients of the formulation
2.Patients currently using other antihemorrhoidal drugs or planning to undergo any surgical procedure for hemorrhoids
3.Pregnant women, or lactating mothers
4.Patients otherwise judged to be inappropriate for inclusion in the study by the investigator
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the efficacy of herbal capsules (HILO) compared to Daflon in patients with Hemorrhoids.Timepoint: Proportion of patients showing improvement in clinical symptoms
- Secondary Outcome Measures
Name Time Method To evaluate the safety of the investigational product in Indian patients <br/ ><br> <br/ ><br>Timepoint: Proportion of patients reporting adverse events