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
|
|
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
|
|
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. |