Colic Pain tablet study (Colic is severe spasmodic pain in the abdomen, kidneys, gall bladder or intestines caused by distention, obstruction or inflammation

â??An Open-label, Multicentric, Non-comparative, observational, Phase-IV Clinical Trial to Evaluate Safety, Tolerability and Efficacy of Oral Tablets of Fixed-dose Combination of Camylofin dihydrochloride 50 mg and Diclofenac potassium 50 mg in the treatment of moderate to severe colicâ?? - Anapass Tablet

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/018953

Enrollment

200

Registered

2019-05-06

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: K638- Other specified diseases of intestine

Interventions

Intervention1: Fixed-dose Combination of Camylofin dihydrochloride 50 mg and Diclofenac potassium 50 mg: IP to be administered orally, 3 times a day for 4 days. Control Intervention1: Not Applicable:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects in the age group of 18-65 years (age of assent) 2. Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from the parent and/ or the legally accepted representative. 3. Patients who had at least 6 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 drugs 3. Pregnant and lactating women 4. Patients with a history of hypersensitivity to Camylofin or Diclofenac Sodium 5. Patients with prostatic hypertrophy 6. Patients with glaucoma 7. Patients with mechanical stenosis 8. Patients with serious underlying organic disorders 9. Patients with paralytic ileus 10. Patients with renal or hepatic disorders 11. Patients with previous history of heart problems or stroke 12. Participation in other clinical trials the last three months and doing study.

Design outcomes

Secondary

Measure	Time frame
The secondary objective of this trial is to evaluate efficacy of this FDC in treatment of moderate to severe colicTimepoint: Day 0,3, 5	—

Primary

Measure	Time frame
The primary objective of this trial is to evaluate safety & tolerability of the FDC in treatment of moderate to severe colic.Timepoint: Day 0,3, 5	—

Countries

India

Contacts

Public ContactDr Devesh Kumar

Director

devesh.kumar@innovate-research.com9971169602

Outcome results

None listed

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