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.
- Conditions
- Health Condition 1: K808- Other cholelithiasisHealth Condition 2: R52- Pain, unspecified
- Registration Number
- CTRI/2019/12/022257
- Lead Sponsor
- Khandelwal laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)