| CTRI Number |
CTRI/2018/08/015423 [Registered on: 23/08/2018] Trial Registered Prospectively |
| Last Modified On: |
27/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on karisalankanni chooranam in patients with anaemia |
|
Scientific Title of Study
|
AN OPEN CLINICAL STUDY ON PAANDU NOI (IRON DEFICIENCY ANEMIA) IN CHILDREN WITH THE EVALUATION OF SIDDHA TRIAL DRUG KARISALANKANNI CHOORANAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Karpagavalli |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate Department of kuzhanthai maruthuvam op no 25 No.6 Anna arch road
Arignar Anna Government siddha medical college Arumbakkam Chennai
Government siddha medical college Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
7373127490 |
| Fax |
|
| Email |
Shillu.manimala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr c shanmugapriya |
| Designation |
Lecturer grade II |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate Department of kuzhanthai maruthuvam op no25
No 6 Anna arch road
Arignar Anna Government siddha medical college Arumbakkam Chennai
Government siddha medical college Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445661808 |
| Fax |
|
| Email |
dr.shanmugapriyaa.km@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr k Karpagavalli |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate Department of kuzhanthai maruthuvam op no 25 No 6 anna arch road
Arignar Anna Government siddha medical college Arumbakkam Chennai
Government siddha medical college Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
7373127490 |
| Fax |
|
| Email |
Shillu.manimala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aringar anna Gvernment siddha medical college no 6 Anna arch road nsk nagar arumbakkam Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
No 6 anna arch road Nsk nagar Arumbakkam Chennai |
| 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 |
| Karpagavalli k |
Government siddha medical college |
No 6 Anna arch road Government siddha medical college Arumbakkam Chennai
Chennai
TAMIL NADU |
7373127490
Shillu.manimala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (2) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karisalankanni choornam |
200 to 500 mg twice a day
Adjuvant honey for 28 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Angular stomatitis
Hb level 7 12gm
Pallor of skin,mucous membrane,nail bed,conjunctiva
Lack of concentration
Poor school performance
Fatigue
Constipation |
|
| ExclusionCriteria |
| Details |
Hb less than 7 gram
Known H/O metabolic disorder
Known H/O hemolytic anaemia
Patient with any other serious illness
|
|
|
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 |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
Nil |
|
|
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)
|
30/08/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open clinical study on paandu noi(iron deficiency anaemia )to the evaluate the efficacy of karisalankanni chooranam of 200-500mg twice a day for 28days as internal medicine of sample size 40 . The trial drug karisalankanni chooranam which contains some active herbs having hematinic property which will be helpful in curing Iron deficiency anaemia. |