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CTRI Number  CTRI/2025/04/085315 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study to know the effect of Siddha medicine Thiripalathy Legium with Ayakantha Chenduram in treating Iron Deficiency Anaemia 
Scientific Title of Study   A Clinical evaluation for the effectiveness of Thiripalathy Legium with adjuvant Ayakantha Chenduram in the treatment of Paandu Noi (Iron Deficiency Anaemia) among out-patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha. 
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 L Lohapriya 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room No.7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai - 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  9600159204  
Fax    
Email  drlohapriyalakshmipathy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Nalini Sofia 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room No.7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai - 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  dr.h.nalinisofia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H Nalini Sofia 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room No.7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai - 600047

Kancheepuram
TAMIL NADU
600047
India 
Phone  8939899363  
Fax    
Email  dr.h.nalinisofia@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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr L Lohapriya  Ayothidoss Pandithar Hospital  Room No.7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai - 600047
Kancheepuram
TAMIL NADU 
9600159204

drlohapriyalakshmipathy@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Thiripalathy Legium with adjuvant Ayakantha Chenduram  A compound herbal drug to treat Iron Deficiency Anaemia with internal medicine Thiripalathy Legium at dose of 6g twice a day with adjuvant Ayakantha Chenduram at a dose of 65mg for a period of 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Hb level ranging from seven to nine point nine gram per deciliter According to WHO criteria normal range for adult men is greater than or equal to thirteen gram per deciliter and for adult women is greater than or equal to twelve gram per deciliter
2.Patient willing to undergo blood investigation 
 
ExclusionCriteria 
Details  1.Patient with Renal diseases
2.Patient with Diabetes Mellitus
3.Patient with any malignancy
4.Patient with Tuberculosis
5.Patient with Inherited Blood Disorders
6.Patient with occult blood positive
7.Lactating and pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Haemoglobin level, Red Blood Cell Indices and Peripheral Blood Smear
from the baseline and increase in these haematological parameters will be considered as improvement. 
90 days 
 
Secondary Outcome  
Outcome  TimePoints 
The clinical lab parameters including Serum ferritin and Total iron binding capacity will be assessed.  90 days 
 
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)   05/06/2025 
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 Yet Recruiting 
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

Siddha medicine is one of the holistic healing system of medicine in southern India. According to derangement of three humours (Vali, Azhal & Aiyam) diseases are classified as 4448 in number. Paandu Noi is one among them and been classified into 5 types in Yugi Vaidhya Chinthamani.

According to WHO, Anaemia is defined as a condition with haemoglobin level less than 7.7 mmol/l (13g/dl) in men and 7.4 mmol/l (12g/dl) in women which has a wide variety of causes. Iron deficiency is considered to be the most common cause of anaemia.

PRIMARY OBJECTIVE

To evaluate the effectiveness of Siddha formulation Thiripalathy Legium with adjuvant Ayakantha Chenduram in the treatment of Paandu Noi (Iron Deficiency Anaemia) through haematological investigation of Haemoglobin in Hb gm%, Red Blood Cell Indices and Peripheral Blood Smear before and after treatment.

SECONDARY OBJECTIVE

Assessment of improvement through other clinical laboratory blood parameters including Serum Ferritin level and Total Iron Binding Capacity (TIBC).

TREATMENT PLAN

Day 1: Arakku Thailam is advised for oil Bath.

Day 2: Agasthiyar Kuzhambu a gentle laxative is advised.

Day 3: Patient is advised to take rest.

Day 4: Thiriphalathy legium will be given as interventional medicine for 90 days.

INTERVENTIONAL DRUG

Internal medicine : THIRIPALATHY LEGIUM

Dosage : Arai Thola (6g), Twice a day

Adjuvant : Aya kantha Chenduram, 65mg

Duration : Orumandalam (90 days)

 PRIMARY OUTCOME

Assessment of Haemoglobin level, Red Blood Cell Indices and Peripheral Blood Smear from the baseline and increase in these haematological parameters will be considered as improvement.

SECONDARY OUTCOME

The clinical lab parameters including Serum ferritin and Total iron binding capacity will be assessed.

 
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