| CTRI Number |
CTRI/2020/12/029948 [Registered on: 21/12/2020] Trial Registered Prospectively |
| Last Modified On: |
19/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical trial to study the effect of the drug paandu legiam in patient having paandu noi(Iron deficiency anaemia). |
|
Scientific Title of Study
|
PHASE II NON RANDOMIZED CLINICAL STUDY ON PAANDU NOI(IRON DEFICIENCY ANAEMIA)WITH EVALUATION OF SIDDHA TRIAL DRUGPAANDU LEGIYUM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpavathi N |
| Designation |
PG Scholar |
| Affiliation |
Government siddha meical college Chennai 106 |
| Address |
Post graduate Room no 25 Department Of Kuzhanthai Maruthuvam Government siddha medical college chennai 106
Post graduate Room no 25 Department Of Kuzhanthai Maruthuvam Government siddha medical college chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9159548644 |
| Fax |
|
| Email |
pushpavathibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rani V |
| Designation |
HOD AND Lecturer |
| Affiliation |
Government siddha medical college Chennai 106 |
| Address |
Post graduate Head of the department Department of Kuzhanthai maruthuvam Government siddha medical college chennai -106
Post graduate Head of the department Department Of Kuzhanthai Maruthuvam Government siddha medical college chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9442286863 |
| Fax |
|
| Email |
ranimoorthybsms19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushpavathi N |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college chennai 106 |
| Address |
Post graduate Roon no 25 Department of Kuzhanthai maruthuvam Government siddha medical college chennai 106
Post graduate Room no 25 Department Of Kuzhanthai Maruthuvam Government siddha medical college chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9159548644 |
| Fax |
|
| Email |
pushpavathibsms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college,chennai |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
6,Anna Arch Road NSK Nagar Arumbakkam Chennai -106 |
| 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 |
| DrN Pushpavathi |
Government siddha medical college |
Department of kuzhanthai maruthuvam NSK nagar Arumbakkam
Chennai
TAMIL NADU |
9159548644
pushpavathibsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
paandu legiyum |
2 gm of legiyum bd after food for 21 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Hb 8 to 12gm/dl
Pallor of skin mucous membrane nail bed lower palpabral conjuctiva
Constipation
Tiredness
Generalised muscular weakness
Poor school performance and lack of concentrate
|
|
| ExclusionCriteria |
| Details |
Hb less than 8gm
Known H/O Hemolytic anaemia
Hereditary bleeding disorder i.e(Hemophilia)
Patient with chronic disease i.e (Thalassemia,chronic malnutrition) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome is assessed by reduction of the clinical symptoms before and after treatment |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary outcome is assessed by comparing the safety parameters before and after treatment |
21 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)
|
29/12/2020 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single Non Randomized Open Clinical Trial to study the safety and efficacy of siddha trial drug pandu legiyum is to be given about 2g twice a day for 21 days.Clinical trial conducted after conducting pre clinical Toxiciy study.The trial drug paandu legiyum has mentioned in Agathiyar vaithiya sindhamani.During the trial study related data will be recorded and documented after the completion of trial all data will be statistically analysed. |