Colic Pain tablet study (Colic is severe spasmodic pain in the abdomen, kidneys, gall bladder or intestines caused by distention, obstruction or inflammatio
- Conditions
- Health Condition 1: K638- Other specified diseases of intestine
- Registration Number
- CTRI/2019/05/018953
- Lead Sponsor
- Cliniexperts Services Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method The secondary objective of this trial is to evaluate efficacy of this FDC in treatment of moderate to severe colicTimepoint: Day 0,3, 5