A Study on Aswathy Chooranam in the management of Pitha Paandu (Iron Deficiency Anaemia)

Phase 2

Not yet recruiting

• Conditions: Iron deficiency anemia, unspecified,

• Registration Number: CTRI/2023/08/056606
• Lead Sponsor: National Institute of Siddha

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-13
• Study Start: 2023-08-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of Aswathy chooranam through the change in the Haemoglobin	18 MONTHS
level of the study patients before & after treatment	18 MONTHS

Secondary Outcome Measures

Name	Time	Method
1.Reduction of clinical symptoms before & after treatment	2.Assessment of the clinical laboratory parameters like Total RBC, PCV, MCV, MCH, MCHC

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr N A Bharathi

Principal investigator

8072549689

cadbury156@gmail.com