An observational phase IV clinical trial for treatment of Primary Dysmenorrhoea, Colic of an Oral Tablets of Fixed-dose Combination of Camylofin Dihydrochloride 50 mg and Paracetamol IP 325 without any comparator medicine to be conducted at different centers.

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 Paracetamol IP 325 mg in the treatment of Primary Dysmenorrhoea, Colicâ??

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022257

Enrollment

200

Registered

2019-12-05

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: K808- Other cholelithiasis Health Condition 2: R52- Pain, unspecified

Interventions

Intervention1: Fixed-dose Combination of Camylofin Dihydrochloride 50 mg and Paracetamol IP 325 mg: Oral tablet, to be taken thrice a day for 4 days. Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1) Subjects in the age group of 18-45 years (with painful menses) 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 Primary Dysmenorrhoea, 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 Paracetamol 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

Primary

Measure	Time frame
The Primary objective of this Phase IV trial is to find out safety & tolerability of the productTimepoint: Day 5 (after 4 days of therapy)	—

Secondary

Measure	Time frame
The secondary objective of this Phase IV trial is to find out efficacy of the product by clinical global impressionTimepoint: Day 5 (after 4 days of therapy)	—

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