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observational, Phase-IV Clinical Study to Evaluate Safety data, Tolerability and Efficacy of Injection of Fixed-dose Combination of Camylofin Dihydrochloride 25 mg and Diclofenac Sodium IP 25 mg per ml with Benzyl alcohol IP in the treatment of Colic(Severe Abdominal Pain)

An Open-label, Multicentric, Non-comparative, observational, Phase-IV Clinical Trial to Evaluate Safety, Tolerability and Efficacy of Injection of Fixed-dose Combination of Camylofin Dihydrochloride 25 mg and Diclofenac Sodium IP 25 mg per ml with Benzyl alcohol IP in the treatment of Colic Protocol ID: Klab/CT/Camy_Diclo/012017 - ANAPAS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014463
Enrollment
200
Registered
2018-06-07
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: K812- Acute cholecystitis with chronic cholecystitis

Interventions

None listed

Sponsors

Cliniexperts Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject in group of 18-65 years(age of ascent) 2. Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from parent and/or legally accepted representative 3.Patients who had at least six months previous history of confirmed diagnosis of colic

Exclusion criteria

Exclusion criteria: 1. Not willing to sign ICF 2. Patients Known or thought to be hypersensitivity, to study drug 3. Pregnant and lactating women 4. patient with history of hypersensitivity to Camylofin or Diclofenac Sodium 5. Patient with prostatic hypertrophy 6. Patients with glaucoma 7. Patient with mechanical stenosis 8. Patients with serious underlying organic disorders 9. Patients with paralytic ileus 10. Patient with renal and hepatic disorder 11. Patient with previous history of heart problems and stroke. 12. Participation in another clinical trial in last months and doing study.

Design outcomes

Primary

MeasureTime frame
Primary StudyObjective The primary objective of this trial is to evaluate safety & tolerability of the FDC in treatment ofColic Secondary Study Objective Thesecondaryobjectiveofthis trialis toevaluateefficacyofthis FDCintreatmentofColic. Timepoint: 1 hour 3 hours and 24 hours

Secondary

MeasureTime frame
Secondary Study Objective The secondary objective of this trial is to evaluate efficacy of thisTimepoint: 1 hour 3 hours and 24 hours

Countries

India

Contacts

Public ContactDr Devesh Kumar

IR Innovate research Private Limited

devesh.kumar@innovate-research.com9971169602

Outcome results

None listed

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