A multi-centre study to compare and evaluate a herbal capsule in patients with hemorrhoids

Phase 4

Completed

Conditions: Unspecified hemorrhoids,

Registration Number: CTRI/2017/10/010038

Lead Sponsor: Zuventus Healthcare Limited

Brief Summary: Hemorrhoids are a very common anorectal condition affecting millions of people worldwide. Low compliance associated with non-pharmacological treatment along with adverse effects or complications associated with other therapeutic modalities renders use of herbal medicines as an important therapeutic option for management and treatment of hemorrhoids.

The present study is conducted to compare the efficacy and safety of herbal medicines Hilo and Daflon, the treatment of hemorrhoids.

Primary study objective is to assess the efficacy of herbal capsule (HILOTM) compared to Daflonin patients diagnosed with Hemorrhoids.

Secondary objectives : 1. Global assessment of efficacy by investigators and patients.

2. To evaluate the safety of the investigational drug in Indian patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1.Patients of either gender, aged â‰¥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.	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

Trial Locations

Locations (4): Janta Hospital And Maternity Centre
🇮🇳
Varanasi, UTTAR PRADESH, India
King Georges Medical University, Lucknow
🇮🇳
Lucknow, UTTAR PRADESH, India
Santosh Hospital
🇮🇳
Bangalore, KARNATAKA, India
Vijan hospital and research centre
🇮🇳
Nashik, MAHARASHTRA, India
Janta Hospital And Maternity Centre
🇮🇳Varanasi, UTTAR PRADESH, India
Dr Amit Bhaskar
Principal investigator
9580210470
dramitbhaskar@gmail.com