| CTRI Number |
CTRI/2021/07/034536 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Paandu Kudineer For Paandu Noi(Iron Deficiency Anaemia) |
|
Scientific Title of Study
|
Phase II Non Randomized Clinical Study On Paandu Noi(Iron Deficiency Anaemia) With The Evaluation Of Siddha Trial Drug Paandu Kudineer In Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayalakshmi V |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai-106. |
| Address |
Post graduate Room no25 Department of Kuzhanthai Maruthuvam Government Siddha Medical college Chennai106
Post graduate Room no25 Department of Kuzhanthai Maruthuvam Government Siddha Medical College Arumbakkam Chennai106
Chennai
TAMIL NADU
600106
India |
| Phone |
7708030753 |
| Fax |
|
| Email |
vijivenkatesh234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rani V |
| Designation |
HOD and Lecturer |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai-106. |
| Address |
Post graduate Head of the Department Department of Kuzhanthai Maruthuvam Government Siddha Medical college Arumbakkam Chennai106
Post graduate Head of the Department Department of Kuzhanthai Maruthuvam Government Siddha Medical College Arumbakkam Chennai106
Chennai
TAMIL NADU
600106
India |
| Phone |
6369113461 |
| Fax |
|
| Email |
drvranimd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayalakshmi V |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai-106. |
| Address |
Post graduate Room no25 Department of Kuzhanthai Maruthuvam Government Siddha Medical college Chennai106
Post graduate Room no25 Department of Kuzhanthai Maruthuvam Government Siddha Medical College Arumbakkam Chennai106
Chennai
TAMIL NADU
600106
India |
| Phone |
7708030753 |
| Fax |
|
| Email |
vijivenkatesh234@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- 600106 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V Vijayalakshmi |
Government Siddha Medical College |
Departmrnt of Kuzhanthai Maruthuvam NSK Nagar Arumbakkam.
Chennai
TAMIL NADU |
7708030753
vijivenkatesh234@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: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Paandu kudineer
|
15-30 ml bd after food for 21 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Pallor of Skin, Mucous membrane, Nail bed
Lower Palpebral Conjuctiva
Constipation
Tiredness
Generalised Muscular Weakness
Poor School Performance and Lack of Concentration. |
|
| ExclusionCriteria |
| Details |
Hb less than 7grams
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 |
| Reduction in Clinical Symptoms before and after treatment |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing 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)
|
12/07/2021 |
| 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 Paandu Kudineer is to given about 15-30ml twice a day for 21 days. Clinical trial conducted after conducting Preclinical Toxicity study. The trial drug Paandu Kudineer has mentioned in Sigicha Rathna Deepam Part I. During the trial study related data will be recorded and documented After the completion of trial all data will be stastistically analysed. |