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Observational study to evaluate and compare the intensity and duration of pain

A randomized, open labeled, observational study to evaluate the intensity and duration of pain at the injection site and safety upon intramuscular administration of Diclotal AQ® [Diclofenac sodium 75 mg/mL solution for injection (manufactured by Akums Drugs and Pharmaceuticals Ltd., India)] and Dynapar AQ® [Diclofenac sodium 75 mg/mL solution for injection (manufactured by Troikaa Pharmaceuticals Ltd., India)] in patients with arthritisâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/08/009381
Enrollment
12
Registered
2017-08-16
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- In patients with arthritis

Interventions

None listed

Sponsors

Akums Drugs and Pharmaceuticals
Lead Sponsor
Mudra Clincare
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients already diagnosed with arthritis (Rheumatoid arthritis or Osteoarthritis), at least 6 months before to screening. 2 Patients (male and female) having arthritis pain with VAS score up to 7 (mild to moderate pain). 3 Patients with Health Assessment Questionnaire Disability Index (HAQ-DI) score between 0-2 for each question. 4 Patients who are able to and willing to provide written informed consent. 5 Cooperative and understanding skills. 6 Patients willing and assessed to be able to participate in all aspects of the core study, including administration of intramuscular injection in the gluteal region, completion of evaluations, and compliance with protocol requirements.

Exclusion criteria

Exclusion criteria: 1 Hypersensitivity to the drugs components or other drug from same class. 2 Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g. benzodiazepines) for the duration of their participation in the study 3 Patient with history of drug of abuse. 4 Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury, suffering from severe headache 5 Patients recently faced any viral or bacterial infection. 6 Patients have received any biological disease modifying anti rheumatic drugs (eg. Methotrexate, Cyclosporine etc.) 7 Any psychiatric diseases (including major depression), epilepsy, blood disorders like porphyria. 8 Patients under treatment for chronic allergy. 9 Clinical evidence of immunosuppression. 10 Having participated in other clinical trial less than one year prior to screening.

Design outcomes

Primary

MeasureTime frame
To determine the change in the VAS scale scoreTimepoint: after 4 hours—

Secondary

MeasureTime frame
Number of participants reporting adverse eventsTimepoint: 4 hours;Number of participants reporting hypersensitivity reactionsTimepoint: 4 hrs;Number of participants reporting presence of other parameters such as hives, itching, skin rash, wheezing or breathing difficulty, swelling of the face, lips or tongue, faintingTimepoint: 10 minutes, 60 minutes and 240 minutes—

Countries

India

Contacts

Public ContactDr Harshad Dabhade

Mudra Clincare

dr.harshad01@yahoo.com

Outcome results

None listed

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