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CTRI Number  CTRI/2025/01/079620 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy and safety of Siddha medicine vs. iron folic acid for iron deficiency anemia in women of reproductive age 
Scientific Title of Study   Efficacy and safety of Siddha regimen for management of mild to moderate iron deficiency anaemia amongst reproductive age-group women as compared to iron folic acid supplements: An open labelled, multicentric randomized controlled trial 
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 P Shanmugapriya 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room No.26, Department of Nanju Maruthuvam, Siddha Division, National Institute of Siddha, Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  09962513101  
Fax    
Email  sppriyaathamu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrPShanmugapriya 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room No.26, Department of Nanju Maruthuvam, Siddha Division, National Institute of Siddha Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  09962513101  
Fax    
Email  sppriyaathamu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrPShanmugapriya 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Room no.26, Department of Nanju Maruthuvam, Siddha Division, National Institute of Siddha Tambaram Sanatorium

Chennai
TAMIL NADU
600047
India 
Phone  09962513101  
Fax    
Email  sppriyaathamu@gmail.com  
 
Source of Monetary or Material Support  
ICMR-National Institute of Traditional Medicine, Nehru Nagar, Belagavi, Karnataka, India. Pincode 590 010 
National Institute of Siddha, Tambaram Sanatorium, Chennai, TamilNadu, India. Pincode 600 047 
 
Primary Sponsor  
Name  National Institue of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium, Chennai, TamilNadu, India. Pincode 600 047 
Type of Sponsor  Other [Autonomous body, National Institute of Siddha] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manish Barvaliya  ICMR-National Institute of Traditional Medicine  Room No.3, Siddha Clinic, Integrative Clinic, Department of Health System Research
Belgaum
KARNATAKA 
9726901845

drmanishbarvaliya@gmail.com 
P Shanmugapriya  National Institute of Siddha  Room no.26, Department of Nanju Maruthuvam, Siddha Division
Chennai
TAMIL NADU 
9962513101

sppriyaathamu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Siddha  Approved 
Institutional Human Ethics Committee ICMR-National Institute of Traditional Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E611||Iron deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Allopathic regimen  Albendazole 400 mg OD – Once at baseline visit Ferrous Sulphate 200 mg + Folic Acid 0.5 mg BD orally for 3 months  
Intervention  Siddha Regimen  1. ArakkuThailam- 50 ml 2. Naakku Poochi Kudineer -30 ml HS 3. Bavana Kadukkai- 2-tab B.D 4. Aya Bringaraja Paanitham 15 ml B.D  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Women of reproductive age group from 18 to 49 years with mild to moderate iron deficiency anemia
Serum ferritin lesser than 30 mcg per dL
Should consent to receive any type of intervention before randomization
Not participating in any other research study
 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Women planning for pregnancy in the next 3 months at the time of screening
Known case of anaemia due to other causes including thyroid dysfunction and anaemia of chronic diseases
Known diabetics on anti-diabetic drugs
Those who have HbA1C greater than 7
Those who are already consuming IFA more than 14 days
Known allergy to iron and ingredients of Siddha regimen
Patient with known chronic kidney and liver disease
Any other condition in advice of treating doctor that is putting participant on risk due to study participation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The average change in Hb level at timepoint one two and 3 months as compared to baseline
Average change in Serum iron Total Iron binding capacity Ferritin Transferrin saturation levels at baseline and 3 months
Average RBC MCV MCH and MCHC levels at timepoint 1 2 and 3 months as compared to baseline
Association of Mukkutram categories at baseline with Hb improvement
 
Baseline 15th day end of one two and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Proportions of treatment emergent adverse events   Baseline, 15days, 30days, 60days, 90days 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   10/02/2025 
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="2"
Months="6"
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  

Anemia/Paandu is one of the important illnesses, which cause a severe disease burden among Indians. The World Health Organization (WHO) has estimated that globally, 1.62 billion people are anemic and it was especially prevalent among rural areas of India. According to WHO global statistics, 40% of pregnant women, and 42% of children under the age of five are anaemic. It alters immune mechanisms and also associated with increased morbidity rates. The economic and social growth of a nation is impacted by anaemia, as it is attributed to delayed cognitive and motor development in children and reduced work capacity in adults (WHO, 2022).The WHO has recognised iron deficiency anaemia (IDA) as the most common nutritional deficiency in the world, with 30% of the population being affected with this condition. Although the most common causes of IDA are gastrointestinal bleeding and menstruation in women, decreased dietary iron and decreased iron absorption are also culpable causes. Patients with IDA should be treated with the aim of replenishing iron stores and returning the haemoglobin to a normal level.

In India, seven out of every 10 children from 6 to 59 months are anaemic. Anemia is a major public health concern in India. According to National Health Family Survey 5 (2019-21), 57.2% women of reproductive age group (15 to 49 years) suffer from anemia in India . To reduce the burden of anemia in the country, the Government of India launched Anemia Mukt Bharat Programme in 2018 with the objective of reducing the prevalence of anemia by 3 percentage points per year among children, adolescents, and women in the reproductive age group (15–49 years), between the year 2018 and 2022 . A targeted prevalence reduction of anemia in women of the reproductive age group was set from 57% (2016) to 35% (2022) under this programme [4]. However, the prevalence of anemia has been found to be almost the same. The major issue with IFA supplements is poor compliance due to forgetfulness and intolerable GI side effects Iron deficiency and iron load both can cause oxidative stress which in turn causes intestinal mucosal damage due to inflammation. Thus, iron absorption is affected in most of the anaemic patients which may reduce the effect of oral iron supplements and may cause gastrointestinal problems . The addition of Vitamin C to IFA is helpful in enhancing the absorption of iron by keeping it in a reduced ferrous form. However, it does not address the issue of gastrointestinal side effects. Although the conventional treatment for iron deficiency anaemia involves taking iron supplements like ferrous sulphate or elemental iron, adherence to the medicine is challenging due to variety of adverse side effects like metallic taste, epigastric discomfort, nausea, diarrhoea, constipation, etc. The adverse effects of iron supplements can be reduced by taking medications with food. However, doing so might decrease the absorption of iron. Therefore, there is a need to search for innovative drugs that have better therapeutic value and lesser side effects (Nguyen and Tadi, 2022).

In Siddha system of medicine anaemia condition may be compared with the word Paandu literally means pallor. In this clinicalcondition the conjunctiva, tongue, nail bed turns into pallor and it is having been named as Paandu Noi. Syn:Velluppu Noi, Venmai Noi. There are many herbo mineral medicines which are found effective in alleviating iron deficiency anaemia which contains Punica granataVitis vinifera, Nigella Sativa, Smilax china, processed elemental iron. This study  aims to compare the efficacy of Siddha regimen containing traditional oleation by medicated oil Arakkuthylam[9], deworming by NaakkupoochiKudineer followed byBavana Kadukkai ,Aya BhringarajaPaanitham, constituted for anaemia with Standard of Care. Likewise Aya bhringarajaPaanitham contains iron in its elemental iron in combination with herbal medicines which is indicated for Paandu Noi as per Siddha literature, this is also an effective haematinic which can be used as first line of treatment for anaemia even in pediatric population, this drug has undergone repeated dose 28 day oral toxicity studies and revealed no observed adverse effect level (NOAEL) in animals as per Vijaya Kumar et al. Thus the safety of the drug in human usage was ensured.

Need for a trial

Despite of wide promotion of IFA amongst beneficiaries, the burden of anemia remains the same which suggests the need for additional measures to improve nutrition, compliance, and/or additional use of alternative systems of medicine that can address the issue of assimilation of iron and its GI side effects.

 
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