| CTRI Number |
CTRI/2023/08/056606 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
13/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Aswathy Chooranam in the management of Pitha Paandu (Iron Deficiency Anaemia) |
|
Scientific Title of Study
|
Clinical evaluation of siddha herbal formulation Aswathy Chooranam in the treatment of Pitha Paandu (Iron Deficiency Anaemia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N A Bharathi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072549689 |
| Fax |
|
| Email |
cadbury156@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Vetha Merlin Kumari |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
|
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N A Bharathi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8072549689 |
| Fax |
|
| Email |
cadbury156@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram Sanatorium
Chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room no :7/8
Department of Maruthuvam
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 N A Bharathi |
Ayothidoss Pandithar Hospital |
Room no:7/8
National Institute of Siddha
Tambaram Sanatorium
Chennai 600047
Kancheepuram
TAMIL NADU |
8072549689
cadbury156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aswathy chooranam
|
Verugadialavu (1.5g) two times a day (after food) for 90 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Hb level less than normal range, (According to WHO criteria)
For male: 9-11gms/d1 ( normal: 13 gms/d1]
For female: 8-10gms /dl (normal: 12 gms/d1]
2.Patient willing to undergo blood investigation.
3.Patients who are willing to participate in study and signing in informed consent form |
|
| ExclusionCriteria |
| Details |
1.K/C/O Malignancy
2.K/C/O Chronic Kidney Disease
3.K/C/O Severe Cardiac Disease (or) IHD .
4.Severe systemic illness
5.K/H/O Tuberculosis
6.Patients not willing to give blood sample.
7.Pregnant / Lactating mother
8.K/C/O Inherited blood disorders ( Sickle cell anaemia, Thalassemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of the efficacy of Aswathy chooranam through the change in the Haemoglobin
level of the study patients before & after treatment |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduction of clinical symptoms before & after treatment
2.Assessment of the clinical laboratory parameters like Total RBC, PCV, MCV, MCH, MCHC
before & after treatment
3.Smear study and Serum ferritin levels,TIBC before and after treatment |
18 MONTHS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
24/08/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND: Anaemia refers to the state in which the level of haemoglobin in blood is below the normal range appropriate for the age and sex . Iron is an essential mineral needed to form haemoglobin , an oxygen carrying protein inside red blood cells .Iron deficiency anaemia is characterised by deficiency of haemoglobin in RBC ( low MCH and MCHC ) with low colour index and in many cases the RBC’s are smaller than normal.According to Siddha there are 7 important constituents namely saaram , seneer , oon ,kozhupu , enbu , majjai , sukkilam / suronitham also known as sapthathaathu in which anemia occurs due to the deficiency of the rakthadhatu in the body. According to Yugi Vaithiyasinthamani 800, the symptoms of Pitha paandu coorelates with symptoms of iron deficiency anaemia. This is an open clinical trial that evaluates the effectiveness of Siddha formulation Aswathy chooranam in the treatment of Pitha Paandu (Iron Deficiency Anaemia). OBJECTIVE: PRIMARY OBJECTIVE : Evaluation of Siddha formulation Aswathy chooranam in the treatment of Pitha Paandu (Iron Deficiency Anaemia) through improvement in Haemoglobin level of the study patients before and after the treatment. SECONDARY OBJECTIVE : 1.To evaluate the clinical lab parameters including CBC as per outcome before and after treatment 2.To study the cofactors related to the disease (i.e., age, sex, socio economic status, family history, occupation, habits) etc., and to study the siddha basic principles like Envagaithervu, neerkuri and Neikuri, Udalthathukal, Uyirthathukal, Kaalam, Nilam(Thinai) etc., in PithaPaandu patients. 3.Smear study and Serum ferritin levels, TIBC before and after treatment METHODOLOGY: A total of 30 diagnosed patients of Pitha Paandu (Iron Deficiency Anaemia) within the age limit of 18 to 60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria. Known case of Malignancy, Chronic Kidney Disease, Severe Cardiac Disease (or) IHD, Severe systemic illness, Tuberculosis, Inherited blood disorders ( Sickle cell anaemia, Thalassemia), Patients not willing to give blood sample, Pregnant / Lactating mother will be excluded. OUTCOME: PRIMARY OUTCOME: Evaluation of the efficacy of Aswathy chooranam through the change in the Haemoglobin level of the study patients before and after treatment SECONDARY OUTCOME: 1.Reduction of clinical symptoms before and after treatment 2. Assessment of the clinical laboratory parameters like Total RBC, PCV, MCV, MCH, MCHC before and after treatment 3.Smear study and Serum ferritin levels, TIBC before and after treatment RESULTS AND DISCUSSION : The result will be statistically analysed KEYWORDS: Aswathy chooranam, Pitha Paandu, Iron Deficiency Anaemia |