| CTRI Number |
CTRI/2017/06/008735 [Registered on: 01/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of drug Sarakondrai chooranam in patients having low haemoglobin level |
|
Scientific Title of Study
|
A clinical study on Pitha paandu with the evaluation of Siddha drug Sarakondrai 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 M Shanmuga priya |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
Anna arch Road
NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9489695486 |
| Fax |
|
| Email |
vkgnanavel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Kanakavalli |
| Designation |
Professor |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
Anna arch Road
NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9444122865 |
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Shanmuga priya |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College |
| Address |
Govt Siddha Medical College
Anna arch Road
NSK Nagar
Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9489695486 |
| Fax |
|
| Email |
vkgnanavel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Siddha Medical College,Arumbakkam, Chennai |
|
|
Primary Sponsor
|
| Name |
Govt 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 |
| Dr M Shanmuga priya |
Arignar Anna Government Hospital of Indian Medicine |
Room No.2
Siddha Division
PG General Medicine Department
Arignar Anna Government Hospital of Indian Medicine
Arumbakkam
Chennai
Chennai
TAMIL NADU |
9489695486
vkgnanavel@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 |
Pitha Paandu (Iron Deficiency Anaemia) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sarakondrai Chooranam |
2 grams of Sarakondrai Chooranam will be administered twice a day with milk for 48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Hb below 7-10 gms %
Fatigue
Loss of appetite
Pallor of conjunctiva and nail buds
Dyspnoea on exertion
Ulceration of mouth
Worm Infestation(Hook worm)
|
|
| ExclusionCriteria |
| Details |
History of chronic Renal disorders
History of chronic Liver disorders
History of Thalessemia
History of Bleeding disorder
Vulnerable Populations such as pregnant women, Lactating mothers
ï¶ TB affected individuals, HIV positive
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is mainly assessed by reduction in clinical symptoms and increase in Haemoglobin level by comparing the parameters before and after treatment |
48 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
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)
|
22/09/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single Non randomized open clinical trial to study the safety and efficacy of Siddha trial drug Sarakondrai Chooranam. The trial drug is given 2 grams twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Saarakondrai choooranam is mentioned in Aaviyalikkum amudhamurai surukkam. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically. |