| CTRI Number |
CTRI/2026/04/108482 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on traditional Siddha diagnostic methods and diet in pregnant women with high and normal blood pressure |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY ON NEIKURI AND MANIKKADAI NOOL MEASUREMENTS IN PREGNANCY INDUCED HYPERTENSIVE AND NORMOTENSIVE ANTENATAL CASES: WITH A SIDDHA-BASED DIETARY REGIMEN FORMULATED FROM MUKKUTRAM PRINCIPLES |
| 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 Mathangi P |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Room no 11
Department of noinadal
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9080141450 |
| Fax |
|
| Email |
mathangipari23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan MD S |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Room no 11
Department of noinadal
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundararajan MD S |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Room no 11
Department of noinadal
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital
Palayamkottai
Tirunelveli 627002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mathangi P |
Government siddha medical college and hospital |
Department of Noinadal
Government siddha medical college and hospital
Palayamkottai
627002
Tirunelveli
TAMIL NADU |
9080141450
mathangipari23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government siddha medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normotensive antenatal women in the second and third trimester |
| Patients |
(1) ICD-10 Condition: O169||Unspecified maternal hypertension,unspecified trimester, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in the second and third trimester with a systolic blood pressure greater than or equal to 140 mm Hg and or diastolic blood pressure greater than or equal to 90 mm Hg.
Pregnant women in the second and third trimester with a systolic blood pressure less than 130 mm Hg and or diastolic blood pressure less than 90 mm Hg. |
|
| ExclusionCriteria |
| Details |
Pregnant women with chronic hypertension
Pregnant women with associated systemic illnes.
Unwilling participants. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document and evaluate the Siddha diagnostic methodology Neikuri among pregnancy induced hypertensive and normotensive antenatal women. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| |
|
To assess the manikadai nool measurement in Pregnancy Induced Hypertensive and Normotensive antenatal women
To propose a dietary regimen based on mukkutram principles for the management of Pregnancy Induced Hypertension |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/04/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
High blood pressure during pregnancy can affect the health of both mother and baby. Early identification and proper care are important to prevent complications. This study aims to observe pregnant women with normal and high blood pressure using traditional Siddha methods and to evaluate the benefits of a Siddha-based diet. |