| CTRI Number |
CTRI/2024/01/061405 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to find out the effect of Camylofin 50 mg and Paracetamol 325mg drug in patients with acute colicky abdominal pain |
|
Scientific Title of Study
|
An investigator initiated prospective single arm open-label study to
evaluate effectiveness of Camylofin 50 mg and Paracetamol 325mg in
patients with acute colicky abdominal pain |
| Trial Acronym |
ACAP Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AMD/P/23/001, Version 1, 22 November 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandravati |
| Designation |
Director |
| Affiliation |
Krishna Medical Center |
| Address |
Krishna Medical Center
1 Rana Pratap Marg Hazratganj Lucknow 226001
Lucknow
UTTAR PRADESH
226001
India |
| Phone |
9839011146 |
| Fax |
|
| Email |
drchandravati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandravati |
| Designation |
Director |
| Affiliation |
Krishna Medical Center |
| Address |
Krishna Medical Center
1 Rana Pratap Marg Hazratganj Lucknow 226001
Lucknow
UTTAR PRADESH
226001
India |
| Phone |
9839011146 |
| Fax |
|
| Email |
drchandravati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandravati |
| Designation |
Director |
| Affiliation |
Krishna Medical Center |
| Address |
Krishna Medical Center
1 Rana Pratap Marg Hazratganj Lucknow 226001
Lucknow
UTTAR PRADESH
226001
India |
| Phone |
9839011146 |
| Fax |
|
| Email |
drchandravati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt Ltd Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club
Bandra (E) Mumbai 400 051 |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Pvt Ltd |
| Address |
Floor 16 Godrej BKC Plot No C 68 BKC Near MCA Club
Bandra (E) Mumbai 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandravati |
Krishna Medical Center |
1 Rana Pratap marg Hazratganj Lucknow 226001
Lucknow
UTTAR PRADESH |
9839011146
drchandravati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira IVF Hospital pvt ltd |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female subjects aged 18 65 years
Patients attending OPD with acute colicky abdominal pain and having at least one episode of colicky pain within 24 hours prior to the visit
Non complicated cases of acute colicky abdominal pain may be confirmed by imaging tests such as Ultrasound Sonography USG performed prior to the treatment initiation to ensure no
complicated cases get recruited as perwill be performed at the discretion of the investigator
Patient willing to provide written informed consent to will be enrolled in the study |
|
| ExclusionCriteria |
| Details |
Patients with history of hypersensitivity to the study drugs any of study drugs ingredients
Patients who had undergone coronary artery bypass graft surgery with epilepsy or inflammatory bowel disease will be excluded
Patients with chronic abdominal pain such as Celiac disease lactose intolerance ulcerative colitis and Crohns disease
Patients who may have narrow angle glaucoma mechanical stenosis Pregnancy and lactation Urinary retention Mega colon GI
hemorrhage Tachyarrhythmia Porphyria
Patients with any other conditions or diseases that investigator considers as ineligible to enroll in the study based on approved
prescribing information |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in the mean intensity of pain based on the 100mm VAS score from baseline to EOS |
Percentage change in the mean intensity of pain based on the 100mm VAS score from baseline to EOS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess how much time it takes on average for people to feel relief from pain by looking at a ten point reduction in the pain intensity score on the visual analogue scale |
To assess how much time it takes on average for people to feel relief from pain by looking at a ten point reduction in the pain intensity score on the visual analogue scale |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute colicky abdominal pain is sudden severe localised urinary or gastrointestinal pain that is usually abrupt and spasm like Evidence suggests that analgesic spasmolytic and anticholinergic agents play supportive roles in relieving pain and symptoms in patients with acute colicky abdominal pain Although there is enough evidence of the effectiveness and safety of Camylofin with other NSAIDs like paracetamol (also called acetaminophen) nimesulide diclofenac and mefenamic acid data on the effectiveness of FDC of Camylofin 50 mg with Paracetamol 325 mg is lacking |