| CTRI Number |
CTRI/2020/01/022603 [Registered on: 03/01/2020] Trial Registered Prospectively |
| Last Modified On: |
13/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Thiratchai Chooranam for the treatment of Vatha Paandu(Megaloblastic Anemia) |
|
Scientific Title of Study
|
Clinical evaluation of Siddha formulation Thiratchai Chooranam in the treatment of Vatha Paandu(Megaloblastic Anemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charumathi V |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:1, Department of Maruthuvam,National Institute of Siddha, Tambaram Sanatorium.
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
9952092086 |
| Fax |
22381314 |
| Email |
charusaravanan94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Kantham T |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:1, Department of Maruthuvam,National Institute of Siddha, Tambaram Sanatorium.
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
9025575185 |
| Fax |
22381314 |
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charumathi V |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:1, Department of Maruthuvam,National Institute of Siddha, Tambaram Sanatorium.
Kancheepuram
TAMIL NADU
600 047
India |
| Phone |
9952092086 |
| Fax |
22381314 |
| Email |
charusaravanan94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium,Chennai-47 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram sanatorium. |
| 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 Charumathi V |
Ayothidoss Pandithar Hospital |
Room no:1, Department of Maruthuvam,National Institute of Siddha, Kancheepuram
Kancheepuram
TAMIL NADU |
9952092086
charusaravanan94@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: D519||Vitamin B12 deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Thiratchai Chooranam |
Thiratchai Chooranam in the treatment of Megaloblastic anemia
Dosage:1.5 gram,twice a day with ghee
Duration:45 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Hemoglobin level:
for male:7-12g/dl
for female:7-11g/dl
serum cobalamin level:100-300pg/ml
serum folic acid level:2-5ng/ml
mean corpuscular volume>100fl |
|
| ExclusionCriteria |
| Details |
pregnant women and lactating mother
patient receiving anti tuberculosis drug
patient underwent gastrectomy
renal disease
cardiac disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It will be assessed by comparing the pre and post treatment cobalamin,folic acid and hemoglobin levels of the patient. |
fourty eighth day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It will be assessed by comparing the reduction of clinical symptoms, changes in blood count before and after treatment |
fourty eighth day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
04/01/2020 |
| 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="3"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an interventional study in which 20 subjects will be recruited based on inclusion and exclusion criteria. After recruitment subjects will be given Thiratchai Chooranam - 1.5 grams,twice a day with ghee for 45 days. After completion blood investigations will be taken for subjects. |