Study evaluating the use of oral DROTIN A (Drotaverine + Aceclofenac combination)for the treatment of post- operative pain after abdominal operations

An open label study evaluating the use of oral Drotaverine + Aceclofenac combination for the treatment of post- operative pain after abdominal operations

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/10/002049

Enrollment

100

Registered

2011-10-11

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: null- post-operative pain after abdominal operations

Interventions

Intervention1: Fixed dose combination of oral Drotaverine (80 mg)+ Aceclofenac (100 mg): FDC-Drotaverine (80 mg) + Aceclofenac(100 mg), one tablet twice daily for 5 days Control Intervention1: Aceclof

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who have undergone abdominal surgery 2. Able to understand and is voluntary willing to sign an informed consent

Exclusion criteria

Exclusion criteria: Males and females of age group: below 18 yrs and above 60(yrs)are excluded from the study. 1. Any open abdominal surgery where oral intake is not allowed. 2. Patients having peptic ulcer disease/ bleeding disorders/hepatic and renal dysfunctions. 3. Known hypersensitivity to any one of the active ingredients / excipients 4. Any active cancer 5. Chronic diseases or recent CV events ( diabetes mellitus / hypertension) 6. Psychotic disorders, dementia, mental retardation (Suspects who are not weakly and mentally able to personally consent for participating in this study are not eligible).

Design outcomes

Primary

Measure	Time frame
post-operative painTimepoint: day 1, day 3 and day 5 in 5 day tratment schedule	—

Secondary

Measure	Time frame
NoneTimepoint: 0	—

Countries

India

Contacts

Public ContactDr Ashish Dey

svmalik@yahoo.com011-42251358

Outcome results

None listed

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