| CTRI Number |
CTRI/2024/03/064732 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
A Pulse diagnosis urine and oil drop examination during three trimesters of pregnancy |
|
Scientific Title of Study
|
A Descriptive study on the Siddha diagnostics parameters Naadi Neerkuri and Neikkuri during the three trimesters of Pregnancy |
| 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 Karbharakshambigai V |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India
Department of Noi Naadal
Room No:20/21
Chennai
TAMIL NADU
600047
India |
| Phone |
8220570375 |
| Fax |
|
| Email |
drkarbharakshambigai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GJ Christian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India
Department of Noi Naadal
Room No:20/21
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GJ Christian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatorium
Chennai
TAMIL NADU
600047
India
Department of Noi Naadal
Room No:20/21
Chennai
TAMIL NADU
600047
India |
| Phone |
99625930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Obstetrics and Gynaecology Government Hospital for Women and Children Egmore |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
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 Karbharakshambigai |
Institute of Obstetrics and Gynaecology Government Hospital for Women and Children |
Institute of Obstetrics and Gynaecology Government Hospital for Women and Children
Egmore Chennai
600008
Chennai
TAMIL NADU
Centre Of Excellence For Obstetrics And Neonatology
A.L. Mudaliyar Block
Chennai
TAMIL NADU |
8220570375
drkarbharakshambigai@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 |
Women with Confirmed Pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women with confirmed Pregnancy |
|
| ExclusionCriteria |
| Details |
Participants who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Documentation of predominant Naadi pattern in each trimesters of pregnancy |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Documentation of various patterns of Naadi Neerkuri & Neikkuri in three trimesters of pregnancy |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION The Siddha system of medicine is the ancient traditional system mainly practiced in the southern part of India deals with physiological psychological, social and spiritual wellbeing of an individual. Siddha system has unique diagnostic methods to identify the diseases and their causes. It includes Naadi, Sparisam, Naa, Niram, Mozhi, Vizhi, Malam and Neer (Neerkuri and Neikkuri). Ancient Siddhars (Founders of the Siddha system) described mother care includes Antenatal, Postnatal and also child care. Pulse detection aids in antenatal care by resolving and preventing antenatal problems. Neerkuri which commonly dealt with physical characteristics of urine and is headed under five domains such as Niram (Colour), Manam (Odour), Edai (Density), Nurai (Froth), and Enjal (Deposits). Neikkuri is the method of urine examination, based on distribution of oil drop in urine which is a remarkable diagnostic and prognostic tool and well explained by sage Theraiyar and Agasthiyar. The purpose of this study to observe the patterns of Naadi, Neerkuri and Neikkuri during the three trimesters of pregnancy.
METHODOLOGY A total 150 participants will be involved in this study. They were screened and enrolled in the study based on the inclusion and exclusion criteria. The collection of data will be documented. OUTCOME PRIMARY OUTCOME : Documentation of predominant Naadi pattern in each trimester of pregnancy. SECONDARY OUTCOME : Documentation of various patterns of Naadi, Neerkuri and Neikkuri in three trimesters of Pregnancy. |