| 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
|
|
|
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
|
|
|
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
|
|
|
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. |