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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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