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CTRI Number  CTRI/2020/06/025609 [Registered on: 04/06/2020] Trial Registered Prospectively
Last Modified On: 07/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to test the efficacy and safety of Lomens-P0 in women with pre menstrual symptoms.  
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel study of Lomens-P0 to evaluate the efficacy and safety on healthy subjects with Premenstrual Syndrome (PMS)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V Narayanaswamy  
Designation  Consultant- Obs and Gynae 
Affiliation  Vagus Super Speciality Hospital 
Address  18th Cross road, Margose road, Malleshwaram West, Bangalore India

Bangalore
KARNATAKA
560003
India 
Phone  9448053952   
Fax    
Email  drnarayanavagus@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anam Khan 
Designation  Medical Writer 
Affiliation  Syncorp Clincare Technologies Pvt. Ltd.  
Address  No:6, 3rd Floor. Arekere Main RoadOff Bannerghatta Main RoadBangalore Landmark: Beside Mithra Academy,Opposite British Biologicals

Bangalore
KARNATAKA
560076
India 
Phone    
Fax    
Email  anam@syncorp.in  
 
Details of Contact Person
Public Query  
Name  Subham Dutta 
Designation  Director 
Affiliation  Syncorp Clincare Technologies Pvt. Ltd.  
Address  No:6, 3rd Floor. Arekere Main RoadOff Bannerghatta Main RoadBangalore Landmark: Beside Mithra Academy,Opposite British Biologicals

Bangalore
KARNATAKA
560076
India 
Phone    
Fax    
Email  subham@syncorp.in  
 
Source of Monetary or Material Support  
GENENCELL CO. LTD.  
 
Primary Sponsor  
Name  GENENCELL CO LTD 
Address  Suite #301, UTOWER, 120, Heungdeokjungang-ro, Giheung-gu, Yonginsi, Gyeonggi-do, Korea  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V Narayanaswamy   Vagus Super Speciality Hospital  Department of Obs and Gynae, 18th Cross road, Margose road, Malleshwaram West, Bangalore
Bangalore
KARNATAKA 		 9448053952

drnarayanavagus@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vagus Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N943||Premenstrual tension syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lomens-P0  Dose: 1 tablet per day (1000mg/day, with Lomens-P0 500mg/day) Treatment duration: 12 weeks 
Comparator Agent  Placebo  contains pharmacological inactive ingredients. Dose: 1 tablet per day (1000mg/day, with Lomens-P0 0mg/day)  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Women aged 19-45 years
2. Subject who voluntarily agrees to participate and signs in ICF
3. Women who have menstruation
4. Menstrual cycle range not longer than 31 or shorter than 24 days for at least last 6 months 5. Subject’s next approaching menstrual cycle not falling within next 10 days from screening day. 6. Mild to moderate symptoms of premenstrual syndrome (score ≥16), identified by the DSR and Follicular score less than 40 identified by the COPE. The scores will be calculated by averaging the scores of six days before 1st day of menstruation for 2 consecutive menstrual cycle from visit 1 to visit 2.  
 
ExclusionCriteria 
Details  1. Subject who took medicine or health functional food related to PMS
2. Subject with a history of uterine cancer and sex hormone-related cancer, or undiagnosed uterine bleeding
3. Subject with a severe migraine or diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or a history of coronary angioplasty within a year
4. Subject with severe mental illness, such as depression and anxiety disorder, or who is currently taking neuro-psychotic drug such as antidepressants
5. Uncontrolled hypertension disease(160/100 mmHg and above)
6. Uncontrolled thyroid disease
7. Drug or alcohol abusers
8. Participated in another clinical trial within one month of the start of this clinical trial, or plan to participate in another clinical trial during the trial
9. Any condition that in the opinion of the investigator does not justify the subject’s inclusion for the study
10. Subject who uses sanitary aids or extra equipment (e.g. Hot water bottle, Instant hot pack, Heating pad (electronical) to abdomen and lumbar, Instant ice pack to limbs) to relieve PMS 11. Subject who plans to conceive within 3 months, Breastfeeding women and pregnant woman 12. Actual or recent participation in psychotherapy due to premenstrual symptoms
13. Allergy with any of the ingredients of the IP 14. Women who are surgically sterilised, hysterectomised, or ovariectomised
15. Subjects on the treatment of infertility
16. Any gynaecological disease like cysts, fibroids, malignancy.
17. Woman reaching menopause
18. Subjects using hormonal contraception  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinically significant positive change from baseline to EOT in the Penn State daily Symptom Report (DSR)   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Clinically significant positive change from baseline to EOT (End of treatment) in The Calendar of Premenstrual Experience (COPE) scores   12 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2020 
Date of Study Completion (India) 04/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A randomized, double-blind, placebo-controlled, parallel study of Lomens-P0 to evaluate the efficacy and safety on otherwise healthy subjects with Premenstrual Syndrome(PMS) for 12 weeks. The enrolled subjects will be randomised into either of the 2 groups in the ratio of 1:1 for a period of 12 weeks (3 months), as one tablet once a day.  
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