| CTRI Number |
CTRI/2025/07/091774 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study compares the safety and effectiveness of three treatments for moderate to severe pain, such as cramps, stomach or kidney pain, back pain, or post-surgery pain. The treatments combine medicines to relieve both pain and muscle spasms. |
|
Scientific Title of Study
|
A 3arm Multicenter, Open label, Randomized Controlled Study Comparing FDC (Diclofenac 50mg plus Paracetamol 325 mg and Dicyclomine HCL 20 mg) and Spasmodart FDC (Fixed-dose Combination of Paracetamol IP 325 mg, Dicyclomine Hydrochloride IP 20 mg and Diclofenac Sodium IP 50 mg ), Phase-IV Clinical study to Evaluate Safety, Tolerability and Efficacy of in moderate to severe pain associated with Primary dysmenorrhoea, Gastro-intestinal colic, Renal colic, Biliary colic, Uterine colic, Spasmodic dysmenorrhoea, Backache, Surgical pain and spasm. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-SD-2022 version 3.0 dated 06.03.2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Goyal |
| Designation |
Obstetrician and Gynecologist |
| Affiliation |
Panchsheel Hospitals Pvt Ltd |
| Address |
C-3/62-A, 63-A, Yamuna Vihar, Delhi-110053, India
North East
DELHI
110053
India |
| Phone |
9811081811 |
| Fax |
|
| Email |
goyalpoonam29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena RM |
| Designation |
Head -Medical Affairs |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karmataka, India
Bangalore
KARNATAKA
560064
India |
| Phone |
09880902005 |
| Fax |
|
| Email |
veena.rm@cliniexpertsresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
Unit No. 325, City Centre all, Plot No. 5, Sector 12, Dwarka, New Delhi, South West, DELHI - 110075
New Delhi, DELHI-110075, India
South West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| JUGGAT PHARMA, No.47/1, 20th km, Mysore Road, Bangalore–560 074, India |
|
|
Primary Sponsor
|
| Name |
JUGGAT PHARMA |
| Address |
No.47/1, 20th km, Mysore Road, Bangalore–560 074 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadanand Nandihalli |
Belagavi Institute of Medical Sciences, Belagavi |
Room No. 69, Department of Orthopedics, Belagavi Institute of Medical Sciences, Belagavi, Dr B R Ambedkar Road, Sadashiv Nagar, Belagavi-590001, Karnataka, India
Bangalore
KARNATAKA |
9738106971
drnsadanand@gmail.com |
| Dr Vidya Jadhav |
Bharti Vidyapeeth Medical College and Hospital Sangli |
1st floor, Clinical Pharmocology and Trial Unit, Bharti Vidyapeeth Medical College and Hospital Sangli, Sangli-Miraj Road, Wanalesawadi, Sangli, Maharashtra-416416, India
Sangli
MAHARASHTRA |
9890836937
vidya.jadhav@bharatividyapeeth.edu |
| Dr Pankaj Kumar Gupta |
ESIC Medical College and Hospital |
Clinical Trial Unit, MRU (Multidisciplinary Research Unit), Basement, ESIC Medical College and Hospital, NH-3, NIT, Faridabad-121001, Haryana, India
Faridabad
HARYANA |
9654214386
drpankajgupta2000@yahoo.com |
| Dr Utsa Basu |
Horizon Life Line Pvt. Ltd. |
Room No. 105, 1st floor, P, 34, CIT Road, Park Circus, Entally, Kolkata, West Bengal 700014, India
Kolkata
WEST BENGAL |
9432658968
dr.utsabasu@yahoo.com |
| Dr Poonam Goyal |
Panchsheel Hospital Pvt. Ltd. |
Ground Floor, Room No. 12, C-3/62-A, 63-A, 64-A, Yamuna Vihar, Delhi-110053, India
North East
DELHI |
9811081811
goyalpoonam29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee Waves Women Empowerment |
Approved |
| Institutional Ethics Committee -BVDU Medical College and Hospital, Sangli |
Approved |
| Institutional Ethics Committee BIMS |
Approved |
| Institutional Ethics Committee for ESIC Faridabad |
Approved |
| Institutional Ethics Committee Horizon Lifeline |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R252||Cramp and spasm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arm II: FDC Diclofenac 50mg + Paracetamol 325 mg
Arm III: Dicyclomine Hydrochloride IP – 20 mg |
Arm II: FDC Diclofenac 50mg + Paracetamol 325 mg
Arm III: Dicyclomine Hydrochloride IP – 20 mg
Dosage- 1 tablet to be taken three times a day, orally with plain water for 5 days |
| Intervention |
Spasmodart |
Arm I: Spasmodart
Each uncoated tablet contains:
Paracetamol IP – 325 mg
Dicyclomine Hydrochloride IP – 20 mg
Diclofenac Sodium IP – 50 mg
Dosage- 1 tablet to be taken three times a day, orally with plain water for 5 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either sex aged between 18 to 60 years
2. Subjects clinically diagnosed with moderate to severe pain (on VAS) due to Primary
dysmenorrhoea, Gastro-intestinal colic, Renal colic, Biliary colic, Uterine colic,
Spasmodic dysmenorrhoea, Backache, Surgical pain & spasm.
3. Subjects who are willing to comply with protocol procedures.
4. Subject who voluntary participate in the study with signed inform consent. |
|
| ExclusionCriteria |
| Details |
1. Not willing to sign ICF
2. Subjects known, or thought to be hypersensitivity, to Paracetamol, Dicyclomine Hydrochloride, Diclofenac Sodium
3. Pregnant and lactating women
4. Subjects with a history of hypersensitivity to Paracetamol, Dicyclomine Hydrochloride, Diclofenac Sodium
5. Subjects having secondary dysmenorrhoea
6. Subjects having mild menstrual pain
7. Subjects with prostatic hypertrophy
8. Subjects with history of glaucoma and Myasthenia
9. Subjects with mechanical stenosis
10. Subjects with history of severe gastritis, peptic ulceration or any gastrointestinal bleeding
11. Subjects with serious underlying organic disorders
12. Subjects with paralytic ileus
13. Subjects with renal or hepatic disorders
14. Subjects with previous history of heart problems or stroke
15. Subjects with history of acute pancreatitis and biliary disorder other than colicky pain
16. Subjects with severe renal disorder
17. History or evidence of significant cardiovascular disease, any malignancy, thyroid dysfunction, epilepsy, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study treatment.
18. Participation in other clinical trials the last three months and doing study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Pain relief using Visual Analogue Scale (VAS) |
2,6,12, 24, 72, 96 hours after post dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physician’s Global evaluation through CGI-I scale
Safety and tolerability of the study drug(s) will be assessed by the Clinical & Laboratory AEs occurring during entire duration of study. |
Baseline to Day 5 |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="9"
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 Phase-IV, multi-center, open-label, randomized controlled study is designed to assess the safety, tolerability, and efficacy of Spasmodart, a fixed-dose combination (FDC) of Paracetamol 325 mg, Dicyclomine Hydrochloride 20 mg, and Diclofenac Sodium 50 mg, in comparison to FDC Diclofenac 50 mg + Paracetamol 325 mg and Dicyclomine Hydrochloride 20 mg. The study targets moderate to severe pain associated with conditions such as primary dysmenorrhoea, gastrointestinal colic, renal colic, biliary colic, uterine colic, spasmodic dysmenorrhoea, backache, and surgical pain and spasm. The primary objective is to evaluate the efficacy of Spasmodart compared to the other two treatments. A total of 210 subjects will participate, with 70 subjects in each study arm. |