None listed
Conditions
Interventions
Intervention1: BBETTER PiloUrja capsules 1000 mg.: One capsule after breakfast and dinner (twice daily) with ambient temperature water for 8 weeks.
Control Intervention1: Placebo Capsule (Identical to
Sponsors
MONKSAYS SUPERFOODS PVT. LYD.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 60 years. 2. Diagnosis of Grade 1 or Grade 2 hemorrhoids based on clinical examination. 3. Experience of symptoms such as pain and discomfort and swelling or bleeding for at least 3 months. 4. Reports of constipation as a contributing factor. 5. Ability and willingness to maintain a fiber-rich diet throughout the study. 6. Agreement to avoid spicy foods during the trial period. 7. Willingness to discontinue any other anti-hemorrhoid medications or supplements. 8. No significant comorbidities or anorectal disorders.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hemorrhoid-related pain and discomfort measured using a 10-point Visual Analog Scale (VAS) from baseline.Timepoint: Baseline, Week 4, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in hemorrhoid size and inflammation as assessed by clinicians from baseline.Timepoint: Baseline, Week 4, Week 8;Improvement in stool consistency and frequency using the Bristol Stool Scale from baseline.Timepoint: Baseline, Week 4, Week 8;Reduction in bleeding episodes recorded in patient-reported diaries from baseline.Timepoint: Baseline, Week 4, Week 8;Change in digestive health assessed via patient questionnaires from baseline.Timepoint: Baseline, Week 4, Week 8;Prevention of new hemorrhoid formation from baseline.Timepoint: Week 4, Week 8;Change in laboratory values for liver parameters (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) from baseline.Timepoint: Baseline, Week 8;Change in laboratory values for kidney parameters (serum creatinine, blood urea nitrogen) from baseline.Timepoint: Baseline, Week 8;Change in Treatment-Emergent Adverse Events (TEAEs) from baseline.Timepoint: Baseline, Week 4, Week 8;Change in Treatment-Emergent Serious Adverse Events (TESAE) from baseline.Timepoint: Baseline, Week 4, Week 8 | — |
Countries
India
Contacts
Public ContactDr Suraj Kumar Pattanayak
Government Medical College & Govt. General Hospital
Outcome results
None listed