| CTRI Number |
CTRI/2022/04/042118 [Registered on: 25/04/2022] Trial Registered Prospectively |
| Last Modified On: |
21/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effectiveness of Thirutharatchatha chooranam for the management of Pitha paandu |
|
Scientific Title of Study
|
Clinical evaluation of Siddha herbal formulation THIRUTHARATCHATHA CHOORANAM in the treatment of Pitha Paandu ( Iron deficiency anaemia). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr A Surya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of siddha |
| Address |
Room no 1 Department of Maruthuvam National institute of siddha Tambaram sanatorium chennai 47
Room no 1 Department of Maruthuvam National institute of siddha Tambaram sanatorium chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072897366 |
| Fax |
22381314 |
| Email |
suryaasaithambi1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H NALINI SOFIA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
National institute of siddha |
| Address |
ROOM NO 1 DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM KANCHEEPURAM CHENNAI
ROOM NO 1 DEPARTMENT OF MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM KANCHEEPURAM CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
22381314 |
| Email |
dr.h.nalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Surya |
| Designation |
PG Scholar |
| Affiliation |
National Institute of siddha |
| Address |
Room no 1 Department of Maruthuvam National institute of siddha Tambaram sanatorium chennai 47
Room no 1 Department of Maruthuvam National institute of siddha Tambaram sanatorium chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072897366 |
| Fax |
22381314 |
| Email |
suryaasaithambi1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Maruthuvam 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 chennai 600047 |
| 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 A Surya |
National Institute of Siddha |
AYOTHIDOSS PANDITHAR HOSPITAL NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 47
Kancheepuram
TAMIL NADU |
8072897366
22381314
suryaasaithambi1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
THIRUTHARATCHATHA CHOORANAM |
THIRUTHARATCHATHA CHOORANAM in the treatment of PITHA PAANDU VERUGADI ALAVU twice a day for 48 days with Honey |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Hb level less than normal range
For male 9-12 gms/dl(Normal 13 gms/dl)
For female 8-11 gms/dl(Normal 12 gms/dl)
Patient willing to undergo blood investigation Patients who are willing to participate in study and signing in informed consent form |
|
| ExclusionCriteria |
| Details |
Presence of any associated severe systematic illness(eg Cancer,AIDS),Chronic kidney disease, Endocrine disorder (Thyroid abnormality,Diabetes mellitus),Severe cardiac disease or IHD, Inherited defects (sickle cell anaemia,Thalassemia,Aplastic anaemia),Patients not willing to give blood sample |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Haemoglobin level of the study patients before and after treatment |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of clinical symptoms before and after treatment Assessment of the following RBC,PCV,MCV,MCH,MCHC,PLT,ESR,Total WBC,DC,Smear study before and after treatment Serum Ferritin test before and after treatment |
Fourty Ninth Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
08/05/2022 |
| 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="17" |
|
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
|
It is an interventional study in which 30 patients with the clinical symptoms of Pitha paandu such as Hb level less than normal range For male :9-12 gms/dl (Normal :13 gms /dl ) For female :8-11 gms/dl (Normal :12 gms/dl),patient willing to undergo blood investigation,patients who are willing to participate in study and signing in informed consent form will be selected based on inclusion and exclusion criteria.After enrolling patients in the study ,THIRUTHARATCHATHA CHOORANAM Verugadi alavu will be given twice a day for 48 days with honey.After 48 days patient will be asked to do blood investigations for any changes in it and absence of clinical signs and symptoms of pitha paandu. |