EFFICACY OF VIDANGADI LOHA IN THE MANAGEMENT OF PANDU W S R IRON DEFICIENCY ANEMIA  A RANDOMISED CONTROLLED CLINICAL TRIAL

NEED FOR STUDY

Pandu is considered as a Santarpanajanya and Rasapradoshaja vyadhi¹. It is a pitta dominant Tridoshaja vyadhi where vivarnata of twak is the main feature.² Features of Pandu are similar to the disease Iron Deficiency Anaemia in the modern science. Iron deficiency anemia (IDA) is a worldwide health problem and it is the commonest form of nutritional deficiency³. According to WHO estimates, IDA affects 30% of the total world population⁴. India is one of the countries in the world that has highest prevalence of anaemia. It is associated with increased morbidity and mortality in women and children, poor birth outcomes, decreased work productivity in adults and impaired cognitive and behavioural development in children⁵. Timely intervention in IDA raises productivity level by as much as 20%.

               Ayurveda is one of the traditional health sciences which is actively seeked in the management of common health issues including anaemia.  Ayurveda advocates use of various formulations in the management of Pandu but they remain to be validated. Few studies have been conducted showing benefical effect of Dhatri avaleha⁶ Trikatrayadi loha⁷ in IDA in adults. However, these studies lack the methodological rigor. According to many research studies Ayurveda herbo mineral formulation, Punarnava mandura⁸ has proved to be effective ayurveda drug in the management of Pandu.

Vidangadi loha⁹(VL) explained in bhaishajya ratnavali is an Ayurveda iron based herbomineral formulation have Lauha bhasma  Vidanga Trikatu and Triphala. These drugs when administered with lauha bhasma increases the absorption, distribution, metabolism and excretion of iron.¹⁰ VL possess Rasayana properties conferring the holistic approach of Ayurveda towards healthcare. There is a requirement of new kind of formulation with better bioavailability  absorption of iron in the body for effective management of IDA.¹¹ Hence the current study is planned to evaluate the efficacy of Vidangadi loha in management of IDA.

REVIEW OF LITERATURE

Pandu is a pitta pradhana tridoshaja vyadhi. Acharyas include pandu in rasa pradoshaja vikara,so improper rasa dhatu further effecting the production of rakta dhatu resulting in alpa rakta ( decreased blood cells) as one of the main feature along with panduta¹². Panduta is the pratyatma lakshana of all varieties of Pandu. Based on the causative factors, it is classified into five types viz Vataja Pittaja Kaphaja Sannipataja and Mrtbhakshanajanya. The symptoms of Pandu are panduta of twak  netra  nakha and anana shrama arohanaayasa daurbalya  pindikodwestana and aruchi.¹³ 

Iron Deficiency Anaemia the most prevalent single nutrient deficiency condition characterised by insufficient   iron intake balance, iron stores, and the body s loss of iron¹⁴ for supporting erythropoiesis leading to fatigue reduced physical endurance decreased cognitive performance and other unpleasant symptoms. IDA occurs when iron deficiency is suffiently severe to reduce the production of haemoglobin. Contemporary medicine advises iron supplements in the form of haematinics formulations like ferrous gluconate ferrous ascorbate ferrous succinate ferric citrate ferrous sulphate¹⁵ to treat IDA as iron is a noncontroversial metal for therapeutic use since centuries¹⁶.Analysed safety concerns of these conventional formulations includes gastro intestinal side effects like nausea constipation diarrhoea vomiting metallic taste  dark stool¹⁷ and risk of hypotension anaphylaxis infection hypophosphatemia oxidative stress.¹⁸ In spite of the active national campaigns in India/National Health mission on IDA/Nutritional deficiency anaemia through interventions with ferrous sulphate ferrous gluconate ferrous fumarate are given in IDA as oral iron and oral iron for IDA found 40% noncompliance with most citing GI intolerance as a reason for discontinuation¹⁹.

DRUG REVIEW

Punarnavmandura²⁰

VIDANGADI LOHA²¹

VIDANGADI LOHA RASAPANCHAKA

PREVIOUS WORK DONE

Dr Bhavya S (2014) conducted A single blind randomized comparative clinical study of Ayorajadi churna over loha bhasma in the management of Pandu roga w s r to iron deficiency anaemia. Dept of KC, Belagavi. Ayorajadi churna 500 mg TID after food and Loha bhasma 500 mg (100mg+400 mg starch) capsule TID for 45 days and concluded that subjective parameters like Panduta  Daurbalya Arohanayasa  Hrutspandana Shrama and objective parameters Hb percentage ESR Peripheral smear Serum iron gradually.

DR subir kumar khan 2012 conducted study on Efficacy of Trikatrayadi Lauha in Panduroga with reference to Iron Deficiency Anemia.And concluded that Trikatrayadi lauha given 250 mg QID for 2 months and concluded that both groups shown significant effect on the signs and symptoms of shrama shwasa daurbalya  pandu varna hridspandana  hatanala bhrama aruchi  arohanaayasa  shiroruja shotha  and Hb serum iron.

AIM AND OBJECTIVES

AIM

 To study the efficacy of Vidangadi Loha in Anemia

OBJECTIVES

                 To evaluate the efficacy of Vidangadi Loha in the management of IDA.

                 To compare the efficacy of Vidangadi Loha and Punarnava Mandura in IDA

HYPOTHESIS

H0

         Effect of vidangadi loha and punarnava mandura on IDA are comparable

H1

          Effect of vidangadi loha and punarnava mandura on IDA are not comparable

RESEARCH QUESTION

           Whether Vidangadi Loha administration in the dose of 250mg BD for 60 days will be effective in the management of IDA

MATERIALS

Literary source

The source of the data for the present study will be taken from classical texts modern books research articles journals and internet.

Sample source

         Patients having Hb percentage in the range of 7 to 12 will be selected from OPD/IPD of KLEs ayurvedic hospital and MRC  Belagavi.

 Drug source

Punarnava mandura will be procured from GMP certified Ayurveda pharmacy

Vidangadi loha is prepared in GMP certified KLE Ayurveda pharmacy khasbhag Belagavi.

METHODOLOGY

RESEARCH DRUG

Collection

    Authentication and quality assessed raw materials of vidangadi loha will be collected from GMP certified KLE Ayurveda pharmacy khasbhag Belagavi.

Authentication

   ASU certified Authentication of raw drugs will be obtained from Central Research Facility AYUSH approved drug testing laboratory for ASU drugs  KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya &Post Graduate studies Research centre  BELGAVI

Preperation

 All the ingredients will be taken in required quantity and preparation will be done as per SOPs

Procurement of ingredients of vidangadi loha from GMP certified KLE Ayurveda pharmacy  khasbhag  Belagavi and Preparation of vidangadi loha will be carried out at GMP certified KLE Ayurveda pharmacy khasbhag Belagavi.

      Procurement of punarnava mandura from GMP Certified Ayurveda pharmacy will be done.

Analysis

                   Final product will be analysed at AYUSH approved drug testing laboratory for ASU drugs Govt of India KAHERs Shri B M Kankanwadi Ayurveda mahavidyalaya & Research centre BELGAVI

Packaging and Storing

                  The trail drug will be packaged in GMP certified KLE ayurvedic pharmacy, and stored in MRC KLE hospital Belagavi

MAIN STUDY

CLINICAL STUDY

After approval from institutional ethical committee the study will be initiated

STUDY TYPE

Interventional

STUDY DESIGN

Randomised control trial

MASKING

open label

CONTROL

Standard control

END POINT

Efficacy of vidangadi loha and comparability to punarnava mandura in the management of Iron Deficiency Anaemia

GROUPS 2

GROUP A :20

GROUP B: 20

SAMPLE SIZE

40

GROUPS  INTERVENTION

DIAGNOSTIC CRITERIA:

Presence of signs and symptoms of pandu roga like panduta daurbalya aarohanaayasya and laboratory investigations like Hb  peripheral smear  serum iron study

INCLUSION  EXCLUSION CRITERIA

Inclusion Criteria

Age group of 20-60 yrs of both sex

Patients presenting with clinical symptoms of pandu roga that include panduta daurbalya  shrama.

Patients with Hb concentration of 7 –12²² gm  of either gender

Exclusion Criteria

Post haemorrhagic anaemia  sideroblastic anaemia sickle cell anaemia  thalassemia leukaemia

Pregnancy and lactating women

Systemic infective disorders like TB

Bleeding disorders like menorrhagia metrorrhagia DUB bleeding piles

Metabolic and endocrinal disorders hepatic and splenic disorders.

  WITHDRAWAL CRITERIA

Any serious adverse events requiring major interventions.

Any time during the study continuation of study drug could lead to harmful affect.

Subjects failure to follow the instructions of the principal investigator.

Other administrative reasons.

RESCUE MEDICATION

Patients developing aggravation worsening of present clinical condition would be referred to appropriate specialist centre and will be administered rescue medications. Such patients will be excluded from the study.

STUDY SITE

         KLE AYURVEDA HOSPITAL  MEDICAL RESEARCH CENTRE BELAGAVI.

STUDY PERIOD

18 months

ASSESSMENT CRITERIA

SUBJECTIVE PARAMETERS suitable gradings of

panduta

Daurbalyata

Hrudspandanam

Shrama

Arohanayasa

LABORATORY PARAMETERS

Hb%

Peripheral smear

Serum iron

 FREQUENCY OF ASSESSMENT

Subjective parameters will be assessed on baseline 30^th 45^th and 60^th day.

Objective parameters will be assessed on baseline and 60^th day.

STATISTICAL METHODS TO ANALYSE THE DATA

Assessment of Quantitative parameters will be assessed in Within Group  by Paired T test and   Between Groups will be assessed by Independent sample T test. Assessment of Qualitative parameters will be assessed in Within groups  by Wilcoxon sign test and  between group will be assessed with Mann Whitney Test. Level of significance will be p is less than 0.05                                                                                               

EXPECTED OUTCOME

 Vidangadi loha may help in the improvement of symptoms like panduta daurbalyata etc of IDA.  

Does the study require any investigation or intervention conducted on animals, patients or human

 Yes.

ETHICAL CLEARANCE  yet to obtained

CTRI NUMBER yet to be registered

BIBLIOGRAPHIC REFERENCES

Agnivesha charaka samhitha edited by Yadavjitrikamji acharya with ayurvedadika commentary by chakrapanidatta chaukamba prakashan Varanasi 2009 sutra 23 of 5 p 122

 Khan SK Vyas SN Chandola HM  Efficacy of Trikatrayadi Lauha in Panduroga with reference to Iron Deficiency Anemia Ayu  2012 33 1 62 67  doi 10 4103 0974 8520 100313

 Das SN  Devi A  Mohanta BB  Choudhury A Swain A Thatoi PK  Oral versus intravenous iron therapy in iron deficiency anemia  An observational study  J Family Med Prim Care 2020 9 7 3619 3622  Published 2020 Jul 30  doi 10 4103 jfmpc jfmpc 559 20

Li N  Zhao G  Wu W  et al The Efficacy and Safety of Vitamin C for Iron Supplementation in Adult Patients With Iron Deficiency Anemia  A Randomized Clinical Trial. JAMA Netw Open. 2020;3(11):e2023644. Published 2020 Nov 2. doi:10.1001/jamanetworkopen.2020.23644

 Ning S, Zeller MP. Management of iron deficiency. Hematology Am Soc Hematol Educ Program. 2019;2019(1):315-322. doi:10.1182/hematology.2019000034

 Rupapara AV, Donga SB, Dei L. A comparative study on the effect of Pandughnivati and Dhatrilauhavati in the management of Garbhinipandu (Iron Deficiency Anemia). Ayu. 2013 Jul;34(3):276-80. doi: 10.4103/0974-8520.123120. PMID: 24501523

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 Pandya MG, Dave AR. A clinical study of Punarnava Mandura in the management of Pandu Roga in old age (geriatric anemia). Ayu. 2014 Jul-Sep;35(3):252-60. doi: 10.4103/0974-8520.153735. PMID: 26664234.

 lalchandraji p,shri haridattashastri p,edition 8,baishajya ratnavali of govindadasvirachitha,panduroga chapter 10, verse 24.varanasi,2016,pg 225

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  Kulkarni S, Mohanty N, Kadam NN, Swain N, Thakur M. Green Synthesis to Develop Iron-Nano Formulations and Its Toxicity Assays. J Pharmacopuncture. 2020;23(3):165-172. doi:10.3831/KPI.2020.23.3.165

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 Ning S, Zeller MP. Management of iron deficiency. Hematology Am Soc Hematol Educ Program. 2019;2019(1):315-322. doi:10.1182/hematology.2019000034

 Gupta KL, Pallavi G, Patgiri BJ, Galib, Prajapati PK. Critical review on the pharmaceutical vistas of Lauha Kalpas (Iron formulations). J Ayurveda Integr Med. 2012;3(1):21-28. doi:10.4103/0975-9476.93944

 Gupta KL, Pallavi G, Patgiri BJ, Galib, Prajapati PK. Critical review on the pharmaceutical vistas of Lauha Kalpas (Iron formulations). J Ayurveda Integr Med. 2012;3(1):21-28. doi:10.4103/0975-9476.93944

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