| CTRI Number |
CTRI/2026/03/106698 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post Marketing Surveillance Study to evaluate safety and effectiveness of the Fixed Dose Combination of Aceclofenac plus Drotaverine Tablets in the Treatment of Patients with Primary Dysmenorrhoea
|
|
Scientific Title of Study
|
Post Marketing Study of Aceclofenac plus Drotaverine Tablets in the Treatment of Primary Dysmenorrhoea |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ipca/ADPD/PMS-24 Version 01 dated 10.06.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02266474641 |
| Fax |
|
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Medical Affairs and Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02266474641 |
| Fax |
|
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Chandurkar |
| Designation |
Senior Vice President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Clinical Research department, Plot 142-AB, 2nd floor Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02266474622 |
| Fax |
|
| Email |
nitin.chandurkar@ipca.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ipca Laboratories Ltd |
| Address |
Plot No. 142-AB, Kandivli Industrial Estate, Kandivli (W) Mumbai-400067, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ms Ipca Laboratories Ltd |
125-AB, Kandivli Industrial Estate, Kandivli West, Mumbai-400067, Maharashtra |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanuja Paipuru |
Aster Prime Hospital |
Department of Obstetrics and Gynaecology, Opposite Passport Seva Kendra, Ameerpet
Hyderabad
TELANGANA |
04049594959
tanujapaipura@gmail,com |
| Dr Saumya DS |
BGS Global Institute of Medical Sciences |
Dept of Obstetrics & Gynecology,
No. 67, BGS Health and Education
Bangalore
KARNATAKA |
9741073960
drsaumyadas.research@gmail.com |
| Dr Deepthi Bawa |
Citizen Hospital |
Number 14, 2nd main dispensary road, Kalasipalya
Bangalore
KARNATAKA |
9880996866
deepthibawa@gmail.com |
| Dr Manasi Kathaley |
Dr Vasantrao Pawar Medical College Hospital & Research Center |
Obstetrics and Gynaecology, OPD no 7, first floor
Nashik
MAHARASHTRA |
9423968322
manasihk65@gmail.com |
| Dr Bidisha Roy Choudhury |
IPGMER and SSKM Hospital |
Department of Obstetrics and Gynecology
Kolkata
WEST BENGAL |
9674945879
bidisha_roychoudhury@yahoo.co.in |
| Dr Neha Vashisth |
Jaipur National University Institute for Medical Sciences & Research Centre |
Dept of Obstetrics & Gynecology, Agra Bypass Road, Jagatpura
Jaipur
RAJASTHAN |
9257036514
vashisthdrneha@gmail.com |
| Dr Sahaja Kittur |
Karnataka Medical College and Research Institute |
Department of Obstetrics and Gynecology, Hubli-580021
Dharwad
KARNATAKA |
9480497610
drsahajakittur@rediffmail.com |
| Dr Rekha Sachan |
King Georges Medical University |
Dept of Obstetrics & Gynecology, Shah Mina Rd, Chowk,
Lucknow
UTTAR PRADESH |
8765000700
drrekhasachan@gmail.com |
| Dr Uthpala Vadakaluru |
Mahatma Gandhi Medical College and Research Institute |
Dept of Obstetrics & Gynecology, Pony Cuddalore ECR Main Road, Pillayarkuppam,
Pondicherry
PONDICHERRY |
7013208734
uthpalavadakaluru@mgmcri.ac.in |
| Dr Laxmi Rachakonda |
MGM Medical College and Hospital |
Dept of Obstetrics & Gynecology, N 6, Cidco, Chha. Sambhajnagar 431003
Aurangabad
MAHARASHTRA |
9823018558
laxmi.yamajal@gmail.com |
| Dr Uday Patel |
Mitra Prashuti Gruha |
Shop No 59, Surabhi Park Society, Shri Hari TWP, Madhavpuara
Vadodara
GUJARAT |
9825265077
mitrauday78@yahoo.com |
| Dr Akurati Nilima |
Renova Neelima Hospital |
Dept of Obstetrics & Gynecology, Opposite Voltas Company, Sanathnagar
Hyderabad
TELANGANA |
9848233335
paleruneelima74@gmail.com |
| Dr Asha Neravi |
SDM College of Medical Sciences and Hospital |
Department of Obstetrics & Gynecology, Unit 2, Room no.7
Dharwad
KARNATAKA |
9845292343
ashaneravi.obg@gmail.com |
| Dr Sachin Rawal |
Shri Tulsi Hospital |
Department of Gynaecology,
OPD first floor-Gynac
Kolhapur
MAHARASHTRA |
9552137679
sachinrawal179@gmail.com |
| Dr S K Rajeswari |
Sri Ramchandra Hospital |
Department of Obstetrics and Gynaecology, Clinical Research Division, G Block, Ground Floor, Dental College Basement
Chennai
TAMIL NADU |
9444953203
drrajeswari1966@gmail.com |
| Dr Shraddha Shastri |
Sushrut Hospital |
Department of Gynaecology and Obstetrics, OPD-2
Pune
MAHARASHTRA |
7507711446
drshraddhashastri@gmail.com |
| Dr Mugdha Jungari |
The Purple Womens Hospital |
Shop No 6 Radhakrishana Sahanivas Apartment, IT Park Road, Gayatri Nagar
Nagpur
MAHARASHTRA |
9223501891
drmugdhajungari@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics Committee |
Approved |
| Aureus Institute of Medical Sciences |
Approved |
| Citizen Hospital Institutional Ethics Committee |
Approved |
| Ethics Committee Prime Hospital |
Approved |
| Ethics Committee Sanjeevan Hospital |
Approved |
| IEC BGS Global Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee for KGMU |
Approved |
| Institutional Ethics Committee JNUIMSRC |
Approved |
| Institutional Ethics Committee Neelima Hospital |
Approved |
| Institutional Ethics Committee SDM College Of Medical Sciences |
Approved |
| Institutional Ethics Committee SRIHER |
Approved |
| Institutional Human Ethics Committee |
Approved |
| IPGMEandR Research Oversight Committee |
Approved |
| KMCRI Ethics Committee |
Approved |
| MGM Ethics Committee for Research on Human Subject |
Approved |
| Om Sai Onco Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aceclofenac plus Drotaverine |
Aceclofenac 100 mg plus Drotaverine 80 mg Fixed dose combination orally twice daily for three days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients aged between 18 to 35 years (both inclusive)
2.Patients with normal gynecological examination and normal ultrasound findings of uterus and adnexa
3.Female patients with history of primary dysmenorrhoea characterized by painful spasmodic cramping in the lower abdomen, just before and / or during menstruation (lasting for 8 to 72hrs)
4.Patients should have history of onset of primary dysmenorrhic symptoms within 5 years of menarche
5.Patient should have painful menses in at least 4 of previous 6 menstrual cycles
6.Patients reporting a pain intensity of more than or equals to 6 on a 11 point Pain Intensity Numerical Rating Scale (PINRS)
7.Patients should have history of regular menstrual cycles
8.Patients agree to participate and follow up in the study
|
|
| ExclusionCriteria |
| Details |
1.Patients with history or presence of recurrent pelvic or lower abdominal pain outside the menstrual period or have dysmenorrhoea secondary to endometriosis, adenomyosis, uterine myomas, endometrial polyps, cervical stenosis or pelvic inflammatory disease
2.Patients with disease or history of abnormalities of the reproductive organs confirmed by clinical examination and ultrasound.
3.Patients with presence or history of using intrauterine devices or oral/injectable contraceptives within 6 months
4.Patients receiving NSAIDs for any other condition or with history of intake within 48 hours prior to study
5.Patients with history of peptic ulcer disease, severe gastritis, gastrointestinal bleeding or any other significant comorbidity which may interfere in the study as per the Investigator’s opinion
6.Patients with history of hypersensitivity to drotaverine or NSAIDs
7.Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document the real life safety and tolerability of Aceclofenac (100 mg) plus Drotaverine (80 mg) tablets |
Baseline to End of Study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in pain intensity score |
0, 2, 4, 8, 24, 48, 72 hours |
| Mean change in pain relief score |
2, 4, 8, 24, 48, 72 hours |
| Patients and Physician global impression on study drug effectiveness |
End of Study |
| Proportion of Patients requiring rescue medication |
End of Study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This open label, prospective, active post marketing surveillance study evaluates the Fixed-Dose Combination (FDC) of Drotaverine 80 mg and Aceclofenac 100 mg in patients with primary dysmenorrhoea. Patients will receive one tablet twice daily for a maximum of 3 days. The objective of study is to document the real-life safety and effectiveness of Aceclofenac (100 mg) + Drotaverine
(80 mg) tablets in the management of primary dysmenorrhoea.
|