| CTRI Number |
CTRI/2018/06/014596 [Registered on: 20/06/2018] Trial Registered Prospectively |
| Last Modified On: |
01/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trail to study the effect of Siru vilvathi elagam in patient with Mannun veluppu noi |
|
Scientific Title of Study
|
An open clinical study to evaluate the clinical efficacy of Siddha sasthric formulation Siru vilvathi elagam for the treatment of Mannun veluppu noi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Sociya parvin |
| Designation |
PG Scholar |
| Affiliation |
goverment siddha medical college and hospital palayamkottai |
| Address |
goverment siddha medical college and hospital
palayamkottai
goverment siddha medical college and hospital
palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8098487815 |
| Fax |
|
| Email |
drmsociya189@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K SHYMALA |
| Designation |
LECTURER GRADE 2 |
| Affiliation |
goverment siddha medical college and hospital palayamkottai |
| Address |
goverment siddha medical college and hospital
palayamkottai
goverment siddha medical college and hospital
palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Sociya parvin |
| Designation |
PG Scholar |
| Affiliation |
goverment siddha medical college and hospital palayamkottai |
| Address |
goverment siddha medical college and hospital
palayamkottai
goverment siddha medical college and hospital
palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8098487815 |
| Fax |
|
| Email |
drmsociya189@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD Goverment siddha medical college and hospital palayamkottai |
| Library goverment siddha medical college and hospital palayamkottai |
|
|
Primary Sponsor
|
| Name |
M Sociya parvin |
| Address |
goverment siddha medical college and hospital palayamkottai |
| Type of Sponsor |
Other [PG scholar (stif fund)] |
|
|
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 |
| M Sociya Parvin |
Goverment siddah medical college and hospital |
OP NO 7 post graduate department of kuzhanthai maruthuvam
Tirunelveli
TAMIL NADU |
8098487815
drmsociya189@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
mannun velupu noi , (1) ICD-10 Condition: D508||Other iron deficiency anemias, (2) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Siru vilvathi elagam |
2.5gm/Kg/BW/daily bid orally for 27 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
patient with appropriate symptoms of fatigue anorexia worm infestation pallor of skin tongue mucous membrane conjunctiva and nail buds Hb between 7 to 10gms patient who are willing to sign consent form and undergo laboratory investigations |
|
| ExclusionCriteria |
| Details |
patient with chronic infection more than age of 13 renal and liver diseases congenital heart disease anemia due to blood loss anemia due to internal bleeding aand Hb less than 7gms |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the therapeutic efficacy of trail drug SIRU VILVATHI ELAGAM on MANNUN VELUPPU NOI |
the therapeutic efficacy of trail drug SIRU VILVATHI ELAGAM on MANNUN VELUPPU NOI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of siddha diagnostic parameters |
27 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
28/06/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/06/2018 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is prospective open labeled non randomized phase 2 clinical trail to evaluate the therapeutic efficacy of trail drug siru vilvathi elagam 2.5gm/Kg/BW/two times a day for 27 days in 40 patients during the trail period of 13 months that will be conducted in Goverment diddha medical college and hospital palayamkottai Tamilnadu The primary outcome will bethe therapeutic efficacy of trail drug Siru vilvathi elagam on Mannun Veluppu Noi The secondary outcome willbe the evaluation of siddha diagnostic parameters |