| CTRI Number |
CTRI/2020/12/030017 [Registered on: 24/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study to Evaluate the onset of Analgesic Effectiveness and Safety of Combination of Camylofin (50 mg) and Nonsteroidal Anti-Inflammatory Agent Mefenamic acid (250 mg) in Patients with Moderate to Severe Primary Dysmenorrhea |
|
Scientific Title of Study
|
"A prospective, single-center, Investigator initiated clinical study to evaluate the
onset of analgesic effectiveness and safety of combination of Camylofin (50 mg) and nonsteroidal
anti-inflammatory agent Mefenamic acid (250 mg) in patients with moderate to severe primary
Dysmenorrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IIS-AM-001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pragya Pandey |
| Designation |
Gynaecologist |
| Affiliation |
Sudbhawana Hospital |
| Address |
Department of Obstetrics & Gynaecology
Sudbhawana Hospital, B31/80, 23B, Bhogabir Lanka, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9696519115 |
| Fax |
|
| Email |
pragyamadhukar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pragya Pandey |
| Designation |
Gynaecologist |
| Affiliation |
Sudbhawana Hospital |
| Address |
Department of Obstetrics & Gynaecology
Sudbhawana Hospital, B31/80, 23B, Bhogabir Lanka, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9696519115 |
| Fax |
|
| Email |
pragyamadhukar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr VairamuthuAmmaiyappan |
| Designation |
Associate Director Project Management |
| Affiliation |
iDD Research Solutions Pvt. Ltd. |
| Address |
Department Clinical Operation & Project Management, 4th Floor, Ektha Serene, located at 103/H | GB & 104 / HIG-B Survey, No 132, APHB Colony, Gachibowli, Hyderabad,
Hyderabad
TELANGANA
500032
India |
| Phone |
9986604998 |
| Fax |
|
| Email |
vairamuthu.ammaiyappan@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| Trial conducted at Sudbhawana Hospital B31/80, 23B-Bhogabir,
Lanka Varanasi-221005
Uttar Pradesh, hospital pharmacy will supply medicine based on prescription by investigator Dr Pragya Pandey and site has all the facilities. |
|
|
Primary Sponsor
|
| Name |
Dr Pragya Pandey |
| Address |
Department of Obstetrics & Gynaecology
Sudbhawana Hospital B31/80, 23B-Bhogabir, Lanka Varanasi-221005 Uttar Pradesh |
| Type of Sponsor |
Other [Investigator Initiated Trial] |
|
|
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 Pragya Pandey |
Sudbhawana Hospital |
Department of Obstetrics & Gynaecology
B31/80, 23B-Bhogabir,Lanka
Varanasi
UTTAR PRADESH |
9696519115
pragyamadhukar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sudbhawana Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z538||Procedure and treatment not carried out for other reasons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anafortan MF (Camylofin 50 mg and Mefenamic acid 250 mg) |
One tablet of Anafortan MF(Camylofin 50 mg and Mefenamic acid 250 mg) is to be taken orally one
tablet in the afternoon and another at night with ambient temperature water after food.
Total study duration will be approximately 1 day including the treatment period. Frequency is first day 3 tablets and remaining is SOS. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Perimenopausal women above 18 years of age and below45years of age
2. Female patients with primary dysmenorrhea on the 1st or 2nd day of their current menstrual cycle
3. History of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles on10-point numeric rating scale
4. Patients willing to provide written informed consent
5. Female of childbearing potential must have a negative pregnancy test and be nonlactating at screening visit.
6. Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period |
|
| ExclusionCriteria |
| Details |
1. Female patients with a history of taking Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg or any other prescription-only and/or non-prescription analgesics, antispasmodics, antidepressants, or antipsychotic medication within the 4 weeks before study enrolment.
2. Patients who are determined as being the risk group for COVID-19.
3. Female patients on antacids, Antihistaminics, tricyclic antidepressants, phenothiazines, disopyramide, pethidine
4. Female patients taking Ace inhibitors, Asprin, Diuretics, Lithium, Methotrexate, Warfarin
5. Female patients with positive urine pregnancy test
6. Lactating female patients
7. Female patients with a history of irregular menstrual cycle in the last 6 months
8. Female patients with secondary dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis) 9. Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
10. Physical examination suggesting a diagnosis of acute abdomen
11. Female patients with a history of upper gastrointestinal bleeding and/or active peptic ulcer
12. Females using an Intrauterine Contraceptive Device (IUCD) or currently using an oral contraceptive for less than 3 months, has been on a unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months or intends to do so in the course of the study
13. Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
14. History of hypersensitivity to study drug or any of its ingredients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To estimate time of onset of action of Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet in patients with moderate to severe primary dysmenorrhea. |
1. Day 1 to day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the analgesic/pain relieving effect of Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet in patients with moderate to severe primary dysmenorrhea.
2. To assess the tolerability profile of the treatment |
1. Day 1 to day 2
2. Day 1 to day 2 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2020 |
| Date of Study Completion (India) |
28/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dysmenorrhea, defined as painful cramps that occur with menstruation, is the most common gynecologic problem in women of all ages and races, and one of the most common causes of pelvic pain. 1, 2.It is commonly divided into primary dysmenorrhea (pain without organic pathology) and secondary dysmenorrhea (pelvic pain associated with an identifiable pathological condition, such as endometriosis. Studies from India reported the prevalence range between 50 to 87.8% (George & Bhaduri, 2002; Patel, 2006; Nair, 2007; Singh, 2008; Agarwal & Agarwal, 2010). Other studies reported that dysmenorrhea affects up to 90% of women of childbearing age to varying degrees (Weissman, 2004).The rationale of the study is to observe and collect safety and efficacy data on Camylofin Dihydrochloride 50 mg, Mefenamic Acid I.P. 250 mg tablet. The analgesic effectiveness will be evaluated by reduction in pain on Visual Analog Scale (VAS) and on Numerical Rating Scale (NRS). |