CTRI Number |
CTRI/2021/01/030354 [Registered on: 08/01/2021] Trial Registered Prospectively |
Last Modified On: |
20/01/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Nutraceutical |
Study Design |
Single Arm Study |
Public Title of Study
|
Safety and Efficacy of Dysmegesic in the management of Menstrual Pain in Female Subjects. |
Scientific Title of Study
|
An Open Label, Prospective, Single Arm, Non-Randomized, Multi-Centric Pilot Study to Evaluate the Efficacy and tolerability of Dysmegesic in the management of Menstrual Pain in Female Subjects. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Prasanna M S |
Designation |
Principal investigator |
Affiliation |
JIP Multispeciality Hospital |
Address |
Department of Gynecology, Ground Floor, JIP Multispeciality Hospital,Sunnambu Colony, Pallavaram
Chennai TAMIL NADU 600043 India |
Phone |
996285258 |
Fax |
|
Email |
drprasannams.research@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Jestin V Thomas |
Designation |
Director |
Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
Address |
#9,1st Floor, Mythri Legacy, Chelekere main road, Kalyan Nagar,
Bangalore KARNATAKA 560043 India |
Phone |
9845125293 |
Fax |
|
Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Jestin V Thomas |
Designation |
Director |
Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
Address |
#9,1st Floor, Mythri Legacy, Chelekere main road, Kalyan Nagar,
KARNATAKA 560043 India |
Phone |
9845125293 |
Fax |
|
Email |
jestin.leadsclinbio@gmail.com |
|
Source of Monetary or Material Support
|
Shield Healthcare Pvt. Ltd,
No. M49 & M50, 2nd Floor, Classic Royal,LB Rd, Chennai – 600020,
Tamil Nadu |
|
Primary Sponsor
|
Name |
Shield Healthcare Pvt Ltd |
Address |
No. M49 & M50, 2nd Floor, Classic Royal,LB Rd, Chennai – 600020, Tamil Nadu |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 5 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Renuka Lalitha Naga Ramaraju |
IVY leaf hospital |
plot no 1 , ground floor,
Ravi complex,beside bajaj electronics, Kondapur
Hyderabad TELANGANA |
9951073666
renuka.rln@gmail.com |
Dr Prasanna M S |
JIP Multi Specialty Hospital |
Department of Gynecology, Ground Floor,Sunnambu Colony, Pallavaram, Chennai TAMIL NADU |
996285258
drprasannams.research@gmail.com |
Dr Pujitha Devi Suraneni |
KIMS - Cuddles |
Department of Gynecology, Kondapur Hyderabad TELANGANA |
9949894522
suranenipujitha@yahoo.co.in |
Dr Sweta Agarwal |
Southern Gem hospital |
5-9-30/1,Palace colony, Basheerbag Hyderabad TELANGANA |
9603890556
drsweta.agarwal@yahoo.com |
Dr Umaiyal Murugesan |
Sri Kumaran Speciality Hospital |
3a,3b,kakkan st, Tambaram west, Tambaram
Chennai TAMIL NADU |
9444152485
umaiyal1966@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 5 |
Name of Committee |
Approval Status |
Balaji Independent Ethics Committee |
Approved |
Balaji Independent Ethics Committee |
Approved |
Balaji Independent Ethics Committee |
Approved |
Balaji Independent Ethics Committee |
Approved |
Balaji Independent Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
females subjects with dysmenorrhea |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Dysmegesic |
Twice a day for 3 days during 2 consecutive menstrual cycles. |
Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
30.00 Year(s) |
Gender |
Female |
Details |
1. Subjects with either “Moderate†or “Severe†dysmenorrhea severity assessment during Visit 1
2. Regular menstrual cycles for atleast 6 months
3. Subjects with body mass index of 18.50 to 30.00 kg/m2 (Both values inclusive)
4. Subjects who understand the nature and purpose of the study and who are willing to comply with study procedures.
5. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
6. Must be willing and able to give informed consent and comply with the study procedures |
|
ExclusionCriteria |
Details |
1. Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, salpingitis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, endometriosis, fibroids, obstructive endometrial polyps, cervical stenosis inflammatory bowel disease, irritable bowel syndrome).
2. Subjects suffering from mild primary dysmenorrhea.
3. Concomitant treatment with oral contraceptives, gonadotrophin releasing hormone agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs.
4. Recent history of abdominal surgery in the last 6 months.
5. Unevaluated gynaecological abnormalities inclusive of oncological diagnosis or suspicion (unexplained vaginal bleeding, cervical dysplasia)
6. Gross developmental defect or congenital abnormalities of uterus
7. Subjects with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities.
8. Pregnant and nursing women or women who have given birth or had a miscarriage.
9. Women who have undergone hysterectomy.
10. Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator.
11. Subjects who are contemplating surgery/ pregnancy within 90 days after scheduled end of study treatment
12. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
13. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Change in VMS & NRS Scores from Baseline to end of each cycle |
Day 0, Day 28, Day 56 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Mean change in Menstrual Symptom Questionnaire (MSQ) score |
Day 0, Day 28, Day 56 |
Mean change in duration of time for pain relief |
Day 0, Day 28, Day 56 |
Mean change inAbsenteeism from work or school/college, Use of any rescue medication |
Day 0 Day 28, Day 56 |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
15/01/2021 |
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) |
Not Yet Recruiting |
Publication Details
|
"None Yet" |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This is an open label, single arm, prospective, multi-centric clinical trial to evaluate the efficacy and tolerability of Dysmegesic, 750 mg. Female subjects aged between 16 and 30 years (both inclusive) suffering from primary dysmenorrhea (PD) of moderate to severe severity and meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent/assent form. Diagnosis was based on the subject’s history and physical examination.During the screening/enrollment, demographic details such as date of birth, education and occupation details will be obtained. Medical history, details of prior and concomitant medications will be elicited. The study procedures will be explained and instructions regarding study assessments will be provided.After passing the eligibility criteria, the subjects will be dispensed the test formulation (Dysmegesic, 750 mg) for self-administering twice a day from the start of menstrual pain for a duration of 3 days for 2 consecutive menstrual cycles. Subjects can take a maximum of 2 additional dose or 1 additional day for pain relief, in case pain persists after 3 days of Dysmegesic administration. Any rescue medication (analgesic) would be permitted after 2 hours of administration, if the test formulation would not be effective to control the symptoms. The details of extra dosing of Dysmegesic or rescue medication, will be noted in the subject dairy. A detailed clinical evaluation of dysmenorrhoea will be done. The efficacy of the test formulation will be assessed by VMS, NRS and MSQ questionnaire at the end of each cycle. The severity of dysmenorrhoea will be assessed by a Verbal Multidimensional Scoring system (VMS) and by Numeric Rating Score system for pain (NRS). Menstrual Symptom Questionnaire (MSQ) will be administered to evaluate the symptoms of dysmenorrhea. The tolerability of the test formulation will be assessed by incidence of adverse events reported. |