| CTRI Number |
CTRI/2021/08/035782 [Registered on: 18/08/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
A siddha diagnostic tool of Male Infertility |
|
Scientific Title of Study
|
A STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY OF NEERKURI AND NEIKURI FOR VARIOUS CAUSES OF “AAN MALADU" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Alexander |
| Designation |
Pg Scholar |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Opno 2,
Department of Noi Naadal,
Government siddha medical College and hospital,
Tirunelveli.
Opno 2,
Department of Noi Naadal,
Government siddha medical College and hospital,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9688588551 |
| Fax |
|
| Email |
v.s.alexsiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S SUNDARARAJAN MDS |
| Designation |
Reader |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Department of Noi Naadal,
Government siddha medical College and hospital,
Tirunelveli.
Department of Noi Naadal,
Government siddha medical College and hospital.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S SUNDARARAJAN MDS |
| Designation |
Reader |
| Affiliation |
Government siddha medical College and hospital |
| Address |
Department of Noi Naadal,
Government siddha medical College and hospital,
Tirunelveli.
Department of Noi Naadal,
Government siddha medical College and hospital.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical College and hospital palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government siddha medical College and hospital palayamkottai |
| Address |
Government siddha medical College and hospital, palayamkottai, Tirunelveli-627002 |
| Type of Sponsor |
Government medical college |
|
|
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 S Alexander |
Government siddha medical College and hospital,palayamkottai |
Government siddha medical College and hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU |
9688588551
v.s.alexsiddha@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: N538||Other male sexual dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Male
Age group:Above 21 years and below 60 years
Loss of Lipido
Azoospermia
Asthenozoospermia
Teratozoospermia
Oligozoospermia
Antisperm antibodies
Varicocele
Testicular atrophy
Retrograde & premature ejaculation
Erectile dysfunction
|
|
| ExclusionCriteria |
| Details |
Age group : below 21 years and above 60 years
Traumatical injury
Chromosomal abnormalities
Hypopituatrism
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Siddha diagnosis specially neerkuri and neikuri used to confirm Aan maladu |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Naadi is used for the diagnosis of aanmaladu |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Assessment of functional group in Herbal formulation Thathuviruthi kuligai through fourier transform infrared spectroscopy.
Evaluation of invitro anti-urolithiasis potential of siddha formulation nerunjil kudineer using struvite crystal growth inhibition assay. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is designed to assess the siddha diagnostic procedures especially Neerkuri and Neikuri in patients of Aan Maladu in yugimuni/Magalir maruthuvam. Assessment of other diagnostic methods such as Naadi nadai is also done. The subject who satisfy the inclusion and exclusion criteria will be enrolled and the test procedures will be done and recorded as per the protocol. |