| CTRI Number |
CTRI/2026/02/103435 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Performance Evaluation Study to Assess the Performance
of Preganews – 06 days sooner (Urine Pregnancy Test Kit) |
|
Scientific Title of Study
|
A Laboratory-Based Performance Evaluation Study to Assess the Performance
characteristics of Preganews – 06 days sooner (Urine Pregnancy Test Kit) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maya Sharma |
| Designation |
Principal Investigator |
| Affiliation |
R P memorial hospital |
| Address |
RP Memorial Hospital,
Sector-5-THA-7,8,9, Jawahar Nagar, Jaipur, Rajasthan-302004 (India)
Jaipur
RAJASTHAN
302004
India |
| Phone |
9571557346 |
| Fax |
|
| Email |
drmayasharma1964@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhaumik Mody |
| Designation |
Head Clinical Research & RWE- Medical Affairs |
| Affiliation |
Mankind Pharma Limited |
| Address |
262, Okhla Industrial Estate,
Phase III, New Delhi - 110020
New Delhi
DELHI
110020
India |
| Phone |
01146541111 |
| Fax |
|
| Email |
bhaumik.mody@mankindpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sandeep Yadav |
| Designation |
Managing Director |
| Affiliation |
Manentia Research Pvt. Ltd |
| Address |
CP-11, Phase III, RIICO, Sitapura Industrial Area, Jaipur , Rajasthan 302022, India
Jaipur
RAJASTHAN
302022
India |
| Phone |
07290072455 |
| Fax |
|
| Email |
syadav@manentiaresearch.com |
|
|
Source of Monetary or Material Support
|
| Mankind Pharma Limited,
262 Okhla Industrial Estate, Phase III, New Delhi-110020
New Delhi, DELHI, 110020-India |
|
|
Primary Sponsor
|
| Name |
Mankind Pharma Limited |
| Address |
262, Okhla Industrial Estate,
Phase III, New Delhi - 110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Maya Sharma |
R P memorial hospital |
Ground floor, OPD room Dr. Maya Sharma, RP Memorial Hospital,
Sector-5-THA-7,8,9, Jawahar Nagar, Jaipur, Rajasthan-302004 (India)
Jaipur
RAJASTHAN |
9666624216
drmayasharma1964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swastic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Laboratory-Based Performance Evaluation Study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ezeefind |
Pregnancy Detection Kit |
| Intervention |
PregaNews-6 Days Sooner |
Total duration will be 30 days.
To determine the analytical sensitivity cut off value of the hCG urine test using hCG
standards from 0 to 20 mIU per mL. Analytical analysis of test kit will done at least for 30 days at levels of 0 to 20 mIU per mL and with positive and negative hcg levels with different interfering substances. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Healthy male and non-pregnant females aged 18 years to 45 years at the time of consent.
2. Able and willing to provide written informed consent prior to any study-related procedure.
3. Capable of providing at least 200 mL of midstream urine in a sterile collection container.
4. Participants who fail screening will not undergo sample collection.
5. Willing to comply with sample collection procedures and study requirements. |
|
| ExclusionCriteria |
| Details |
1. Use of any medication or therapeutic agent containing hCG within the past 30 days.
2. Presence of visible contamination in urine (e.g., blood, feces, excessive mucus, or other impurities).
3. Confirmed urinary tract infection or any condition that may impact urine quality, as per self-report.
4. Inability or unwillingness to comply with the sample collection requirements.
5. Any condition that, in the opinion of the investigator, may interfere with safe participation or sample integrity.
6. Volunteers, in the opinion of investigator, deemed unfit for study participation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess sensitivity and precision of Preganews 06 days sooner kit for detection of B HCG at concentration of 10 mIU/mL in urine sample |
In this study baseline would be B-HCG levels at 0 mIU per mL and treatment phase will be at 5, 7.5, 8, 9, 10, 15, 20 mIU per mL. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- To assess specificity & cross reactivity Preganews 06 days sooner kit for detection of B HCG at concentration of 10 mIU/mL in urine sample
- To compare the results from Preganews 06 days sooner kit with predicate device |
baseline for cross-reactivity with LH is 250 & follow up is at 500 & 1000 IU/mL), Baseline for FSH is 250 & follow up is 500 & 1000 mIU/mL, & for TSH baseline is 250 & follow up is 500 & 1000 µIU/mL.
• To evaluate interference from common exogenous &
endogenous substances in 0, 10, & 100 mIU/mL hCG samples.
• To verify consistent test line intensity & qualitative result accuracy.
• To compare the results with predicate device. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| Date of Study Completion (India) |
Date Missing |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 study is a prospective, non-interventional, laboratory-based study
aimed at collecting urine samples from 50 healthy adult male and non
pregnant female volunteers to evaluate the performance of the Preganews – 06 days sooner (Urine Pregnancy Test Kit) and to prepare contrived urine
samples at predefined hCG concentrations. The study is designed to ensure
that all collected samples are of sufficient quality and volume for analytical
testing, without exposing participants to any investigational drug or
therapeutic intervention. Each volunteer will participate in a single visit,
during which eligibility will be confirmed based on inclusion and exclusion
criteria, written informed consent will be obtained, and a midstream urine
sample of at least 200 mL will be collected. Collected samples will be
visually inspected for contamination, properly labeled with unique participant and sample identifiers, and transported to the laboratory under
controlled conditions (2–8°C) within four hours of collection. Upon arrival,
samples will be gently mixed and divided into aliquots, with one aliquot
used for quantitative B-hCG testing and urine routine test to confirm
negative status, and the remaining aliquots used for pooled urine matrix
preparation and spiking to generate contrived samples at specific B-hCG
concentrations. The primary objective of the study is to ensure the
successful collection, processing, and storage of urine samples suitable for
analytical evaluation of the test strip. As an non-interventional study, no
investigational treatment is administered, and the study carries minimal
risk, limited to the urine collection process and laboratory handling
procedures. All study activities will be conducted in accordance with Good
Clinical Practice (GCP) guidelines, ethical standards, and institutional
regulations, ensuring participant safety, confidentiality, and data integrity
throughout the study. |