| CTRI Number |
CTRI/2023/08/056097 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on pulse reading pattern urine examination in Fibroid uterus patients |
|
Scientific Title of Study
|
An observational study on the Siddha investigatory tool Naadi Neerkuri and Neikkuri in Karuppai Kazhalai (Fibroid uterus) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R S Parkavi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
OPD NO 20
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8778136453 |
| Fax |
|
| Email |
rsparkavi7284@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Ramamurthi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
OPD No 20
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9443178112 |
| Fax |
|
| Email |
ramsnis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Ramamurthi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
OPD No 20
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9443178112 |
| Fax |
|
| Email |
ramsnis@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 R S Parkavi |
National institute of siddha |
OPD No 20 Ayothidoss pandithar hospital
National institute of siddha
Tambaram sanatorium
Chennai 47
Chennai
TAMIL NADU |
9585011745
rsparkavi7284@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 |
| Patients |
(1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients who are already diagnosed with fibroid uterus |
|
| ExclusionCriteria |
| Details |
Patients who is not willing Naadi Neerkuri and Neikkuri examination |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The carried out descriptive patterns of vatham pitham & kabam in naadi Neerkuri and Neikkuri as observed in Karuppai Kazhalai patients and correlation among them will be documented |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2023 |
| Date of Study Completion (India) |
10/09/2024 |
| 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)
|
Not Applicable |
| 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
|
Uterine fibroids or leiomyomas are the most common benign tumors in women of reproductive age their is age dependent it is estimated that 60 percentage of reproductive age group and 80 percentage of women develop the disease by 50 years of age this study is planned to find out the naadi neerkuri neikkuri patterns in karuppai kazhalai which provide information in furthur diagnosis of the disease an observational study using sampling technique which will be carried out of 18 months in the patients at opd and ipd ayothidoss pandithar hospital national institute of siddha with 50 patients as sample size the patients will be selected as per inclusion and exclusion criteria and diagnostic tools like naadi neerkuri neikkuri examination in karuppai kazhalai will be observed the carried out descriptive patterns of vatham pitham and kabam in naadi neerkuri and neikkuri as observed in karuppai kazhalai patients and correlation among them will be documented |