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A clinical trial to study the pain relieving effects of two drugs, flupirtine and ketorolac, in patients treated for heroin use with tramadol.

A comparative study on efficacy of add-on Flupirtine versus add-on Ketorolac in the management of Heroin withdrawal with Tramadol - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/083945
Enrollment
180
Registered
2025-04-02
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: F112- Opioid dependence

Interventions

Intervention1: Add-on Flupirtine: Tramadol 300-400mg (3 divided doses) + Clonidine 0.2-0.4mg (2-3 divided doses) + Lorazepam 1-2mg HS + Flupirtine 100mg TDS Note- Tramadol will be tapered and stoppe

Sponsors

Bhavneesh Saini
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects who give written informed consent for the study. 2. Subjects aged between 18 to 60 years of age. 3. Subjects diagnosed with opioid (heroin) dependence (F11.2) as per ICD-10 and admitted in psychiatry ward of dept. of Psychiatry, GGSMCH, Faridkot for opioid detoxification. 4. Subjects having at least mild pain as part of opioid withdrawal, i.e., scoring at least 3mm on VAS (Visual Analog Scale) and at least 1 point on COWS (Clinical Opiate Withdrawal Scale) scale Bone or joint aches item.

Exclusion criteria

Exclusion criteria: 1. Subjects with history of psychiatric illness and/or intellectual disability. 2. Subjects with neurological illness like Dementia, Parkinson disease, SOL (space occupying lesion), Stroke, etc. 3. Patient with Head Injury. 4. Subjects with any severe medical or surgical illness or taking concomitant medication for such illnesses, e.g., anticoagulants. 5. Subjects dependent upon substance(s) other than heroin, except nicotine.

Design outcomes

Primary

MeasureTime frame
Pain Score on Visual Analog Scale (VAS) and Clinical Opiate Withdrawal Scale (COWS) score.Timepoint: Everyday till discharge (7-10 days of stay)

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactBhavneesh Saini

Guru Gobind Singh Medical College and Hospital, Faridkot

bhavneesh.saini@gmail.com9876586043

Outcome results

None listed

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