| CTRI Number |
CTRI/2025/08/093347 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
How Omega-3 Supplements May Help Control Blood Pressure in Pregnant Women with High blood pressure |
|
Scientific Title of Study
|
Effect of Omega-3 Supplementation on Blood Pressure Regulation in Pregnant Women with Gestational Hypertension |
| 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 P Dhivyaprasth |
| Designation |
Assistant Professor |
| Affiliation |
Swamy Vivekanandha college of Pharmacy |
| Address |
room no: G6, Ground Floor, Department of Pharmacy Practice, Swamy Vivekanandha College of Pharmacy, Elayampalayam, Tiruchengode.
Namakkal
TAMIL NADU
637205
India |
| Phone |
9688588833 |
| Fax |
|
| Email |
drdpsvcp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKB NIVETHANA |
| Designation |
DIRECTOR - ACADEMIC, |
| Affiliation |
SWAMY VIVEKANANDHA MEDICAL COLLEGE HOSPITAL & RESEARCH INSTITUTE |
| Address |
Op no: 27, Ground Floor, Gynaecology, SWAMY VIVEKANANDHA MEDICAL COLLEGE HOSPITAL & RESEARCH INSTITUTE, ELAYAMPALAYAM, TIRUCHENGODE
Namakkal
TAMIL NADU
637205
India |
| Phone |
9442581234 |
| Fax |
|
| Email |
nivethanabalakrishnan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr A Prathap |
| Designation |
Assistant Professor |
| Affiliation |
Swamy Vivekanandha college of Pharmacy |
| Address |
room no: G6, Ground Floor, Department of Pharmacy Practice, Swamy Vivekanandha College of Pharmacy, Elayampalayam, Tiruchengode.
Namakkal
TAMIL NADU
637205
India |
| Phone |
9585454735 |
| Fax |
|
| Email |
prathaparumugam181@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhivyaprasath |
| Address |
Room no: G6, ground floor, Department of Pharmacy Practice, Swamy Vivekanandha College of Pharmacy, Elayampalayam, Tiruchengode, Namakkal. |
| Type of Sponsor |
Other [Self] |
|
|
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 P Dhivyaprasath |
SWAMY VIVEKANANDHA MEDICAL COLLEGE HOSPITAL & RESEARCH INSTITUTE |
Op No: 27, Gynaecology, SWAMY VIVEKANANDHA MEDICAL COLLEGE HOSPITAL & RESEARCH INSTITUTE, ELAYAMPALAYAM, TIRUCHENGODE, NAMAKKAL (DT), TAMILNADU - 637205
Namakkal
TAMIL NADU |
9688588833
drdpsvcp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vivekanandha Medical Care Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O132||Gestational [pregnancy-induced] hypertension without significant proteinuria, second trimester, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ajuvant Therapy |
Omega-3 fatty acids 1300mg, once daily for three months |
| Comparator Agent |
Omega-3 Fatty Acids |
DHA 350
EPA 550
BRAND NAME: WOW LIFE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
18 - 40-year-old pregnant women.
BP Greater Than or equal to 140 bar 90mmHg.
After 20 weeks or 20-34 weeks of gestation.
Singleton pregnancy.
Newly diagnosed with HTN.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The expected outcome of this study is that the combination of labetalol and omega-3 fatty acids will result in greater blood pressure reduction Systolic BP 5- 10mmHg; Diastolic BP 2- 6mmHg compared to labetalol alone (Systolic BP 5- 8mmHg; Diastolic BP 2- 4mmHg) in pregnant women with gestational hypertension |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
Modification(s)
|
|