| CTRI Number |
CTRI/2016/01/006557 [Registered on: 25/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
23/01/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical research study of vallarai nei (Internal medicine) in the treatment of Pithapandu(Iron deficiency Anaemia) |
|
Scientific Title of Study
|
Clinical evaluation of siddha drug Vallarai Nei in the treatment of Pitha Pandu (Iron Deficiency anemia) |
| Trial Acronym |
IDA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K RAJALAKSHMI |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM kancheepuram TAMILNADU 600047 INDIA
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM kancheepuram TAMILNADU 600047 INDIA
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9003010579 |
| Fax |
044-22381314 |
| Email |
drkrajalaxmibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR S MOHAN |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM kancheepuram TAMILNADU 600047 INDIA
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM kancheepuram TAMILNADU 600047 INDIA
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
044-22411611 |
| Fax |
044-22381314 |
| Email |
drmohan139@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR H NALINI SOFIA |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM kancheepuram TAMILNADU 600047 INDIA
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM kancheepuram TAMILNADU 600047 INDIA
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
044-22381314 |
| Email |
dr.h.nalinisofia@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OS SIDDHA CHENNAI TAMILNADU |
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
NATIONAL INSTITUTE OS SIDDHA
TAMBARAM SANATORIUM CHENNAI TAMILNADU |
| Type of Sponsor |
Research institution and hospital |
|
|
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 K RAJALAKSHMI |
Ayothidoss pandithar Hospital |
OPD no. 1 Dept. of Maruthuvam,
National Institute oF Siddha
Chennai -47
Kancheepuram
TAMIL NADU |
9003010579
drkrajalaxmibsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PITHA PANDU(IRON DEFICIENCY ANAEMIA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
VALLARAI NEI(INTERNAL) |
Before starting the treatment for PITHA PANDU,
purgation will be given with op medicine Meganatha kuligai 2pills (only one time)with ginger juice at early morning in empty stomach for one day.
Then the trial drug VALLARAI NEI at a dose of 4ml twice a day continuously for 48days. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Hemoglobin level less than normal range
For male 7 to 12gms/dl For female 7 to 11gms/dl
2)Patient blood smear shows Microcytic Hypochromic RBC
3)Patient willing to undergo blood investigation
4)Patient willing to sign the Informed consent stating that he/she will conscientiously stick to the treatment during 48days but can opt out of the trial of his/her own conscious discretion |
|
| ExclusionCriteria |
| Details |
1)Parasitic infection
2)Pregnancy and lactation
3)History of bronchial asthma
4)History of sinusitis
5)Presence of any severe illness(CA,RA)
6)Endocrine disorder( thyroid abnormality
diabetes mellitus)
7)History of cardiac disease
8)History of renal disease
9)Inherited defects like sickle cell anemia thalassemia aplastic anemia
10)Patient not willing to give blood sample
11)Epilepsy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by comparing the pre and post treatment Haemoglobin level of the trial patient |
Prestudy screening and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is assessed by comparing following parameters before and after treatment
1)Reduction of clinical symptoms
2)Changes in complete blood count
3)Changes in iron supply studies |
Prestudy screening and after treatment |
|
|
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)
|
30/07/2015 |
| 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="0"
Months="1"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single, non -randomized,open -label trial to determine the efficacy and safety of VALLARAI NEI(Prepared from 20 herbal constituents and cow ghee and rock sugar) in patients with Pitha pandu (IRON DEFICIENCY ANAEMIA).In this trial 40 patients will be recruited and before starting the treatment ,purgation will be given with OP medicine Meganatha kuligai 2 pills with ginger juice at early morning at empty stomach for one day.Then the trial drug VALLARAI NEI will be administrated 4ml twice a day after food for a period of 48 days.During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients. During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in OPD /IPD.The entire trial will be monitored by the research monitoring committee of NIS.During this trial all the safety and efficacy parameters will be recorded in the CRF.After completion of the trial all the study related data will be analysed statistically.The outcome of this trial will be published in Indian Journal of Medical Research. |