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Randomised control trial for Evaluation of comparative E?cacy of Pileave Ointment versus Pippalyadi Taila in the Management of Grade II Hemorrhoids

Evaluation of comparative E?cacy of Pileave Ointment versus Pippalyadi Taila in the Management of Grade II Hemorrhoids- A RCT - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078022
Enrollment
90
Registered
2024-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K641- Second degree hemorrhoids

Interventions

None listed

Sponsors

Emami Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients suffering from below mentioned minimum three symptoms of piles: 1. Swelling 2. Tenderness 3. Bleeding (Hb more than 10gm) 4. Perianal Pain 5. Burning 6. Itching/ irritation

Exclusion criteria

Exclusion criteria: 1. Patients suffering from 3rd degree heamorrhoids 2. Patients who develop secondary complication of Colitis, intestinal obstruction etc 3. Any other serious illness e.g. Hepatic or renal failure/Severe Anaemia 4. Known hypersensitivity or allergy to one or more of the herbal ingredients 5. Other debilitating neurological or psychiatric disorders 6. Any condition likely to hinder the compliance with the protocol. 7. Severe infective / other organic illness. 8. Any concomitant serious disorder of organs. 9. Any other drug treatment being received simultaneously on long-term basis.

Design outcomes

Primary

MeasureTime frame
Reduction of symptoms of Haemorrhoids: 1. Swelling 2. Tenderness 3. Bleeding (Hb more than 10gm) 4. Perianal Pain 5. Burning 6. Itching/ irritation assessment of Hemorrhoidal Disease Symptom Score Assessment of Anorectal Symptom Severity and Quality of Life Questionnaire (ARSSQoL) Timepoint: Patients will be assessed 5 times – Baseline 7th day 15th day 21st day 30th day (with medication) 45th day (without medication for follow up) Expecting significant clinical improvement with reduced clinical signs and symptoms in Haemorrhoids as compared to Standard of care .

Secondary

MeasureTime frame
Assessment of Anorectal Symptom Severity & Quality of Life Questionnaire ARSSQoL Improvement In quality of life of heamorrhoid patientsTimepoint: 45th day without medication for follow up Expecting significant clinical improvement with reduced clinical signs & symptoms in Haemorrhoids as compared to Standard of care .

Countries

India

Contacts

Public ContactDr Aditi

Shri Dhanwantry Ayurvedic college and Hospital chandigarh

drshijoyj@gmail.com8547232365

Outcome results

None listed

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