| CTRI Number |
CTRI/2018/03/012850 [Registered on: 26/03/2018] Trial Registered Prospectively |
| Last Modified On: |
26/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
wrist circumference in anemia(low hemoglobin level patients) |
|
Scientific Title of Study
|
A Pilot Clinical Trail To Determine The Diagnostic And Prognostic Significance Of Manikadai Nool In Paandu (microcytic hypochromic anemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Mariya Lourthu Gracy |
| Designation |
PG Student |
| Affiliation |
National Institute Of Siddha |
| Address |
National Institute Of Siddha
Chennai
Op No 5,
Department Of Noi Naadal,
National Institute Of Siddha
West Tambaram,
Chennai 47
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
8508973365 |
| Fax |
|
| Email |
drgracy10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C J Christian |
| Designation |
Associate Professor,HOD i/c |
| Affiliation |
National Institute Of Siddha |
| Address |
National Institute Of Siddha
Chennai
Department Of Noinaadal
National Institute Of Siddha
Chennai 47
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Mariya Lourthu Gracy |
| Designation |
PG Student |
| Affiliation |
National Institute Of Siddha |
| Address |
National Institute Of Siddha
Chennai
Department Of Noi Naadal
National Institute Of Siddha
Chennai 47
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
8508973365 |
| Fax |
|
| Email |
drgracy10@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Siddha
Tambaram Sanatorium,
Chennai 47 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Siddha |
| Address |
National Institute Of Siddha
Tambaram Sanatorium,
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 |
| Dr A Mariya Lourthu Gracy |
Op No 5, Department Of Noi Naadal, National Institute Of Siddha |
National Institute Of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU |
8508973365
drgracy10@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 |
anemia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Hb level
less than 13 in men
less than 12 in women
Fatigue,Shortness of breath,Pale skin,Brittle nails,Cold hands and feets,Poor apetite
|
|
| ExclusionCriteria |
| Details |
Blood loss,Pregnancy,Lactation,vulnerable group
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of predisposition of a particular type manikadai nool measurement to paandu. |
with in 48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of appropriate line of treatment and formulate dietary advice for individual. |
with in 48 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To determine the diagnostic and prognostic significance of manikkadai nool in paandu and generate literature about the above manikadai nool procedure. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Every human race has its own traditional system of medicines and
treatment.The Siddha system of medicine is the oldest of the Indian system of
medicine.It
is an integrated part of Indian system which is very potent and unique in its
own right, by providing healing of the body, mind and soul. There are eight
kinds of diagnosis in Siddha. They are Naadi, Sparisam, Naa, Niram, Mozhi,
Vizhi, Malam, Moothiram. Manikkadai nool (Agathiya soodamani kayiru soothiram)
is one of the diagnostic and prognostic tool in Siddha system of medicine. The
methodology of examination of manikkadai nool is briefly explained in the text
“ Noinaadal Noimudhal Naadal Thirattu – part Iâ€. Manikadai
nool makes cost effective, non invasive diagnostic
and prognostic tool for paandu . |