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CTRI Number  CTRI/2025/07/091058 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   BLINDED DIAGNOSTIC COMPARATIVE STUDY 
Study Design  Other 
Public Title of Study   A study Comparing Naadi Examination and Hormone Testing to detect absence of ovulation in Women with Irregular Periods 
Scientific Title of Study   A Blinded comparative diagnostic study of Naadi examination and progesterone Assay in a consecutive series of patients with features of anovular Menstruation attending NIS 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suthajanani Loganathan 
Designation  PG scholar 
Affiliation  National institute of siddha Tambaram Sanatorium Chennai 47 
Address  Teaching block 2 Department of Noinaadal National institute of siddha Tambaram Sanatorium Chennai 47
PG ladies hostel National institute of siddha Tambaram Sanatorium Chennai 47
Kancheepuram
TAMIL NADU
600047
India 
Phone  9677252674  
Fax  22381314  
Email  sljanani87@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Ramamurthy 
Designation  Associate Professor  
Affiliation  National Institute of Siddha Tambaram Chennai 
Address  Teaching block 2 Department of Noinaadal National institute of siddha Tambaram Sanatorium Chennai 47
National Institute of Siddha Tambaram Chennai 47
Kancheepuram
TAMIL NADU
600047
India 
Phone  9443178112  
Fax  22381314  
Email  ramsnis@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Suthajanani Loganathan 
Designation  PG scholar 
Affiliation  National Institute of Siddha Tambaram Chennai 47 
Address  Teaching block 2 Department of Noi Naadal National institute of siddha Tambaram Sanatorium Chennai 47
PG ladies hostel National institute of siddha Tambaram Sanatorium Chennai 47
Kancheepuram
TAMIL NADU
600047
India 
Phone  9677252674  
Fax  22381314  
Email  sljanani87@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Department of Noinaadal OPD no 20, 21 OPD and IPD of National Institute of Siddha Tambaram chennai 47 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SUTHAJANANI L  NATIONAL INSTITUTE OF SIDDHA  OPD no 20,21 Department of Noinaadal OPD AND IPD TAMBARAM SANATORIUM CHENNAI 47
Kancheepuram
TAMIL NADU 
9677252674
22381314
sljanani87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF SIDDHA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N970||Female infertility associated withanovulation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  I. Patients who are affected with menstrual irregularity
a. oligomenorrhea
b. metrorrhagia
c. menorrhagia

II. Progesterone Dipstix for confirming anovulation

III. USG Abdomen/ pelvis /Transvaginal (follicular study)
 
 
ExclusionCriteria 
Details  i. Pregnancy and Lactating mother
ii. Participants with other cardiac diseases
iii. Kidney diseases and arterial diseases
iv. Mental retardation, and psychiatric issues
v. Participants in emergency conditions/post-operative hospitalized patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The percentage of Specificity, Sensitivity of Siddha Naadi examination in diagnosis of Anovulation with ovulation will be obtained  BASE LINE 
 
Secondary Outcome  
Outcome  TimePoints 
I. Different Naadi patterns if observed in different grades/stages will be documented.
ii. The percentage of positive predictive value and negative predictive value, Likelihood Ratio( LHR) will be obtained
 
BASE LINE 
 
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)   17/07/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 is a prospective, blinded, comparative diagnostic study conducted at Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai, over 18 months. The study aims to evaluate the effectiveness of Siddha Naadi examination in diagnosing anovulatory menstruation in women aged 20–45 years, by comparing it with the gold standard progesterone assay. A total of 100 female participants, 50 participants with  with menstrual irregularities (like menorrhagia, oligomenorrhea, metrorrhagia) and 50 with regular menstruration  will be enrolled. They will undergo hormonal testing (FSH, LH, estrogen, progesterone, etc.) and ultrasound follicular studies. Anovulation will be confirmed through a progesterone dipstick test. Participants will then be randomly and blindly presented to the principal investigator, who will perform Naadi examination without knowing the patient’s identity or diagnosis. An additional (unblinded) investigator will assess Naadi beforehand for comparison. The primary objective is to determine the sensitivity and specificity of Naadi in detecting anovulation. Secondary objectives include calculating the positive and negative predictive values, likelihood ratios, and documenting Naadi patterns across different stages of anovulation. This study is expected to provide scientific validation for the diagnostic utility of Siddha Naadi examination in reproductive health.

 
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