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A clinical trial to evaluate anti-hemorrhoid activity.

Evaluation of Safety and Efficacy of polyherbal agent DRDC/2024/062 in Haemorrhoids - NA

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084821
Enrollment
60
Registered
2025-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: K649- Unspecified hemorrhoids

Interventions

None listed

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants must be willing to commit to medication dosing and assessment visits for evaluation. Participants must be willing to refrain from taking any other medications for treatment of haemorrhoids including painkiller laxatives or stool softener from the outset of the study until final evaluation

Exclusion criteria

Exclusion criteria: Participants who in Investigators opinion will not be able to follow study procedures. Patients currently using other anti-haemorrhoidal drugs or having taken any herbal medications in the last 30 days or planning to undergo any surgical procedure for haemorrhoids will be excluded from the study. Subjects who are pregnant or lactating mothers. Thrombosed & Strangulated pile mass (Haemorrhoids).Known case of Bleeding diathesis, Ulcerative colitis / Crohns disease. Patients with evidence of malignancy. Patient suffering from infective disorders e.g. Hepatitis Tuberculosis, HIV. Patients with significant hepatic renal or cardiovascular ailments will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Minimization of fresh bleeding related to defecation. Reduction from the Discomfort (Pain, Itching) in anal region. Change in size of pile mass.Timepoint: End of 1st, 2nd and 3rd week.

Secondary

MeasureTime frame
Change in mucus secretion. Relieving in burning sensation in anal region. Cramping around anal region. Healing of crack or tear in skin around anal region.Timepoint: day0 to day 28

Countries

India

Contacts

Public ContactDr Baidyanath Mishra

Dabur India Limited

srinivasa.yathapu@dabur.com911203378430

Outcome results

None listed

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