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A clinical study to assess how effective Nirgundi Rectal Suppositories are in managing Pain after Hemorrhoidectomy surgery.

An Open label Randomized controlled clinical study to evaluate the efficacy of Nirgundi Rectal Suppository in the Management of Post-Operative Pain in Haemorrhoidectomy - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107551
Enrollment
40
Registered
2026-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Dr Roshan Umme Hani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients of age group between 21-65 years, either of gender, caste, religion, occupation. 2) Patients who underwent elective Haemorrhoidectomy either Open (MilliganMorgan)and Closed (Ferguson) under spinal anaesthesia. 3) Patients willing to provide written informed consent and follow up the protocol of study will be selected. 4) 1-2 internal haemorrhoids. 5) 1 externo internal haemorrhoid.

Exclusion criteria

Exclusion criteria: 1) Positive reaction to Diclofenac sensitivity test (intradermal) conducted prior to enrolment. 2) Patients who are pregnant or lactating. 3) Participants with a prior history of anorectal surgical interventions or existing comorbid ano rectal conditions. 4) Patients who are operated for haemorrhoids associated with IBS or diagnosed with Crohn s Disease, Ulcerative Colitis. 5) Patients with known allergies or hypersensitivity to Diclofenac. 6) Immune compromised patients. 7) Patients diagnosed with systemic diseases like Tuberculosis, Rheumatoid Arthritis, Ischemic Heart Disease, portal hypertension, Type 2 Diabetes Mellitus, Hypertension. 8) History of Human Immunodeficiency Virus (HIV), HBsAg infection, and Venereal Diseases. 9) Post-operative Anaesthesia Complications. 10) Post-operative Fulminating Infections. 11) Individuals with known history of Chronic Alcoholism. 12)Individuals with a known history of Coagulopathy.

Design outcomes

Primary

MeasureTime frame
Progressive relief from pain due to surgical intervention at operative siteTimepoint: Assessment on every 2 hours of 1st post operative day (1 Day) for gradual relief of pain according to VAS scale

Secondary

MeasureTime frame
To improve the quality of life. -Generation of in-depth analyzed data on different aspect of the disease.Timepoint: 1 Day

Countries

India

Contacts

Public ContactDr Geetanjali Hiremath

Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital Koppal

sanjalihiremath@gmail.com7760346752

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026