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Clinical Trials/CTRI/2024/08/072834
CTRI/2024/08/072834Not yet recruitingPhase 2/3

Effect of Mandukaparni ( Centella asciatica Linn) churna in Pandu w.s.r Iron deficiency Anemia- A Randomized Controlled Clinical Trail

Dr Shivaleela Prabhuswamimath1 site in 1 country30 target enrollmentStarted: January 12, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
a) Complete blood count

Study Overview

Brief Summary

In Ayurveda, Aahara, Nidra and Brahmacharya are said to be the three sub-pillars of health. Among them, Aahara is said to be crucial for maintaining both a healthy body and mind.

Anemia is characterized by diminished levels of Red blood cells / haemoglobin in the bloodstream , it is significant Health concern globally in India and it is particularly prevalent with one of the highest rates reported worldwide. Iron deficiency is identified as the primary cause of Anemia, leading to condition similar to Pandu, which is Santarpanajanya &Rasa-pradoshaja Vyadhi

Iron Deficiency Anemia (IDA) is very common in India and the commonest nutritional deficiency all over the world, but its Prevalence is higher in developing countries like India. In India the Prevalence of Anemia is 52%, WHO estimates that nearly 1/3rd of world’s Population is suffering from Anemia.

The nearest correlation of IDA can be made with Pandu Roga in Ayurveda. Pandu Roga is a disease entity described in Ayurveda which bears great resemblance to the clinical picture of Anemia. In modern era, changing lifestyle via Aahara and Vihara has a significant impact on development of many ailments; Pandu Roga is one of them. It is developed due to impaired formation of Rasa-Dhatu from Aahara Rasa, which in turn leads to depletion in Rakta-dhatu. Rasavaha and Raktavaha srotas are most important in the Patho-physiology of Pandu roga.

Systematic monographs of single drugs can be very useful for clinical application.

Mandukaparni(Centella asiatica Linn) is a small, fast-growing perennial herb found throughout India. It is economically beneficial and abundantly available and is one of the most commonly used green leafy vegetable in some countries due to its high amount of medically important triterpenoids & beneficial carotenoids. It is also known to contain Vit-B, Vit-C, proteins, important minerals and some other phytonutrients such as flavonoids, volatile oils and polyphenol available. In Ayurveda, Dwadasha Ahara Varga is mentioned and among them Shaaka Varga, many vegetables are explained and mentioned in managing conditions similar to Pandu, among them Mandukaparni(Centella asiatica Linn) is one of the potential vegetable.  Properties of Mandukaparni includes Tikta and Kashaya rasa, Laghu guna, Sheeta veerya, Tridosha-shamaka property and Panduhara action these suggest potential efficacy in preventive & managing Anemia.

The best preparation used in modern science is Ferrous Sulphate 100 mg twice a day, but this has adverse effect related to Gastro intestine, hence a novel approach for the management of Pandu roga without using Iron in any form is taken in this particular research study. Mandukaparni in Churna form can be used as a substitute for iron tablets in people suffering from Iron Deficiency Anemia. Keeping all these issues in the mind, present study has been planned to popularize and promote the Mandukaparni in daily intake and to assess the effectiveness of Mandukaparni Churna in adult anemic population.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient not on any Iron supplement medication.
  • Where Hemoglobin concentration value is moderate 8 g/dl – 10 g/dl Individuals of either sex between the age group of 20 to 60 years, irrespective of caste and religion and fulfilling diagnostic criteria of moderate Anemia.
  • Peripheral Smear: Microcytic and hypochromic & normocytic and hypochromic anemia Patients will be selected.

Exclusion Criteria

  • Patient on Iron supplement medication.
  • Hemoglobin concentration more than 10g/dl and less than 8 g/dl Subjects with bleeding disorders and hypotensive.
  • Patients with alcohol dependency or drug dependency.
  • Pregnant or lactating women.
  • Patients suffering from major systemic illness.

Outcomes

Primary Outcomes

a) Complete blood count

Time Frame: baseline, day 60

b) Haemoglobin concentration

Time Frame: baseline, day 60

c) Peripheral smear

Time Frame: baseline, day 60

d) Serum iron

Time Frame: baseline, day 60

Secondary Outcomes

  • Pandutva (Pallor)

Investigators

Sponsor
Dr Shivaleela Prabhuswamimath
Sponsor Class
Other [Self ]
Responsible Party
Principal Investigator
Principal Investigator

Dr Shivaleela Prabhuswamimath

KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya

Study Sites (1)

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