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Effect of Tab HF-PRT01 in Piles

Clinical evaluation of Efficacy and Safety of investigation product (HF-PRT01) in the patient of hemorrhoids an observational study. - HF-PRT01

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/04/018662
Enrollment
12
Registered
2019-04-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K640- First degree hemorrhoids Health Condition 2: K641- Second degree hemorrhoids Health Condition 3: K642- Third degree hemorrhoids

Interventions

Intervention1: HF-PRT01: Proprietary Ayurvedic Medicine

Sponsors

SIDDHAYU AYURVEDIC RESEARCH FOUNDATION
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients (age 18 â?? 65 years) of either sex 2. Clinical symptoms of grade I â?? III haemorrhoids

Exclusion criteria

Exclusion criteria: 1. Patients not willing to participate in the study 2. Patients with complicating comorbid conditions like cardiac disorders, uncontrolled diabetes, renal impairment, hepatic impairment, HIV etc. 3. Patients with severe haemorrhoids due to chemotherapy, radiation or as a complication of other concurrent treatments. 4. Patients with the history of drug abuse, sexual abuse etc.

Design outcomes

Primary

MeasureTime frame
The efficacy was measured using change in clinical parameters (patient reported grading) and grades as per proctoscopy.Timepoint: 15th Day and 30th day

Secondary

MeasureTime frame
Any adverse reaction/ event during the treatment with investigational product will be recorded in the adverse drug reaction form. The subjects will be followed up till the reactions have resolved. The adverse drug reaction form will be used as basis for safety analysis of the investigational product. There are no anticipated adverse effects with the investigational product.Timepoint: 15th Day and 30th day

Countries

India

Contacts

Public ContactDr Omkar Kulkarni

Samshodhanam Healthcare Research Services

ayurom@gmail.com9922435119

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026