| CTRI Number |
CTRI/2026/03/106120 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Siddha Diagnostic Methods (Neikkuri and Naadi) in Pregnant Women with Gestational Diabetes and Healthy Pregnant Women |
|
Scientific Title of Study
|
A Comparative Study on Siddha Diagnostic Tool Neikkuri and Naadi among Karpakaala Neerizhivu Patients (Gestational Diabetes Mellitus) and Healthy Pregnant Women |
| 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 B Maheswari |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
S8, Department of PG Noinaadal, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8760848859 |
| Fax |
|
| Email |
mahisiddha4211@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Muthukumaran |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9841184548 |
| Fax |
|
| Email |
shridharu73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Muthukumaran |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Government Siddha Medical College, Chennai |
| Address |
Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9841184548 |
| Fax |
|
| Email |
shridharu73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Antenatal Care OPD at a Primary Health Centre, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr B Maheswari |
| Address |
Room no S8 , Department of PG Noinaadal,Government Siddha Medical College, Arumbakkam, Chennai -106 |
| 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 B Maheswari |
Government Siddha Medical College |
Room no S8 , Department of PG Noinaadal, Government Siddha Medical College, Chennai -106
Chennai
TAMIL NADU |
8760848859
mahisiddha4211@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Pregnant women
|
| Patients |
(1) ICD-10 Condition: O244||Gestational diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women who meet the following conditions:
Age: 18-45 years
Gravida: primipara & multipara
Clinically diagnosed Gestational diabetes mellitus
Healthy Pregnant women |
|
| ExclusionCriteria |
| Details |
Known case of diabetes mellitus.
Pregnancy with hypertension.
Patient who declines to provide consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A separate diagnostic data set may be created which will be useful in early diagnosis and cost effective.
|
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Affected kuttram will be identified which will be useful in Dietary regimen and line of treatment by using Siddha diagnostic methods Neikkuri and Naadi.
|
One year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/03/2026 |
| 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="0"
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
|
This observational comparative study evaluates Siddha diagnostic methods Naadi and Neikkuri among pregnant women with Karpakaala Neerizhivu (Gestational Diabetes Mellitus) and healthy pregnant women. The study aims to document and compare diagnostic findings to develop useful data for early diagnosis and cost-effective screening using Siddha principles. |