Effect of Ayurvedic drug in Anemia
- Conditions
- Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,
- Registration Number
- CTRI/2021/12/038839
- Lead Sponsor
- KAHERS shri BMK ayurvedic mahavidyalaya
- Brief Summary
**EFFICACY OF VIDANGADI LOHA IN THE MANAGEMENT OFPANDU W S R IRON DEFICIENCY ANEMIA ARANDOMISED 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 Featuresof Pandu are similar to the disease Iron Deficiency Anaemia in the modernscience. Iron deficiency anemia (IDA) is a worldwide health problem and it isthe commonest form of nutritional deficiency3. According to WHOestimates, IDA affects 30% of the total world population4. India isone of the countries in the world that has highest prevalence of anaemia. It isassociated with increased morbidity and mortality in women and children, poorbirth outcomes, decreased work productivity in adults and impaired cognitiveand behavioural development in children5. Timely intervention in IDAraises productivity level by as much as 20%.
Ayurveda is one of the traditional health sciences which is activelyseeked in the management of common health issues including anaemia. Ayurveda advocates use of variousformulations in the management of Pandu but they remain to be validated. Fewstudies have been conducted showing benefical effect of *Dhatri avaleha6Trikatrayadi loha*7 in IDA in adults. However, these studies lackthe methodological rigor. According to many research studies Ayurveda herbomineral formulation, *Punarnava mandura*8 has proved to beeffective ayurveda drug in the management of Pandu.
*Vidangadi loha*9(VL)explainedin bhaishajya ratnavali is an Ayurveda iron based herbomineral formulation have*Lauha bhasma Vidanga Trikatu andTriphala*. These drugs when administered with lauha bhasma increases theabsorption, distribution, metabolism and excretion of iron.10 VLpossess Rasayana properties conferring the holistic approach of Ayurvedatowards healthcare. There is a requirement of new kind of formulation withbetter bioavailability absorption ofiron in the body for effective management of IDA.11 Hence thecurrent study is planned to evaluate the efficacy of *Vidangadi loha* inmanagement of IDA.
**REVIEW OF LITERATURE**
***Pandu***is a*pitta pradhana tridoshaja vyadhi*. Acharyas include *pandu* in rasapradoshaja vikara,so improper rasa dhatu further effecting the production ofrakta dhatu resulting in alpa rakta ( decreased blood cells) as one of the mainfeature along with panduta12.*Panduta* is the *pratyatmalakshana* 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 themost prevalent single nutrient deficiency condition characterised byinsufficient iron intake balance, ironstores, and the body s loss of iron14 for supporting erythropoiesisleading to fatigue reduced physical endurance decreased cognitive performanceand other unpleasant symptoms. IDA occurs when iron deficiency is suffientlysevere to reduce the production of haemoglobin.Contemporary medicine advises iron supplements in the form of haematinicsformulations like ferrous gluconate ferrous ascorbate ferrous succinate ferriccitrate ferrous sulphate15 to treat IDA as iron is anoncontroversial metal for therapeutic use since centuries16.Analysedsafety concerns of these conventional formulations includes gastro intestinalside effects like nausea constipation diarrhoea vomiting metallic taste dark stool17 and risk ofhypotension anaphylaxis infection hypophosphatemia oxidative stress.18In spite of the active national campaigns in India/National Health mission onIDA/Nutritional deficiency anaemia through interventions with ferrous sulphateferrous gluconate ferrous fumarate are given in IDA as oral iron and oral ironfor IDA found 40% noncompliance with most citing GI intolerance as a reason fordiscontinuation19.
**DRUG REVIEW**
*Punarnavmandura*20
| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
|Drug
Rasa
Guna
Veerya
Vipaka
Doshagnatha
Rogagnatha
|Punarnava mandoora
Madhura,
Tikta
Kashaya
Laghu
Rooksha
Ushna
Katu
kaphavatahara
Pandu
Kamala
**VIDANGADI LOHA21**
| | | | | |
| --- | --- | --- | --- | --- |
|**DRUG**
**LATIN NAME**
**PART**
**PROPORTION**
**Pharmacological activity**
|*Vidanga*
Embelia ribes Burm.f.
Beeja
1 part
Antioxidant,
Neuro protective,
|*Haritaki*
Terminalia chebula
Retz.
Phala
1 part
Antioxidant,
Immunomodulator
|*Bibitaki*
Terminalia belerica
Roxb.
phala/phala majja
1 part
Rejuvenative,
Hepatoprotective
|*Amalaki*
*Emblica officinalis*
*Gaertn.*
*Phala*
1 part
Anti oxidant
immunomodulator
|*Sunti*
Zinziber
Officinalis
Kanda
1 part
Anti-oxidant
|*Maricha*
Piper nigrum Linn.
Phala
1 part
Neuroprotective
Digestion
|*Pippali*
Piper
longum Linn
Phala
1 part
Immunomodulatory
Anti oxidant
hepatoprotective
|*Lohabhasma*
Ferrum
7 parts
Hematinics
Absorption
**VIDANGADI LOHA RASAPANCHAKA**
| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
|**Drug**
**Rasa**
**Guna**
**Veerya**
**Vipaka**
**Doshakarma**
**Rogagnata**
|*Vidanga*
Katu
Laghu
ruksha,tikshna
ushna
Katu
kapha-vata shamaka
Sula,krimiroga
Aadhmana,udara roga,vibandha hara
|*Haritaki*
Pancha rasayukta lavana rahitha
Laghu
Ruksha
ushna
madhura
Tridoshahara
aadhmana,
vishamajwara
gulma
|*Bibitaki*
Kashaya
Ruksha
Laghu
ushna
madhura
tridoshahara kapha shamaka
Trushna
Krimi
jwara
|*Amalaka*
amla rasa
Laghu
ruksha
vyavayi
vikasi
shita
madhura
Tridoshaghna
Raktasravaarodhaka
Raktapitta
pradara
|*Sunti*
Katu
Guru
ruksha
tikshna
ushna
Katu
kapha-vataghna
Shula
Gulma
Anaha
|*Maricha*
Katu
Laghu
Tikshna
ushna
Katu
kapha vata
shamaka
Krimi
Shula
kasa
|*Pippali*
Katu
Laghu
snigdha
tikshna
ushna
madhura
kapha-vata shamaka
Plehashula
Gulma
Udara roga
|*Loha*
*Bhasma*
madhura,amla,
tikta,Kashaya
ruksha,guru
madhura
Shita
kapha pitta shamaka
Pandu
**PREVIOUS WORK DONE**
Dr BhavyaS (2014) conducted A single blind randomized comparative clinical study of *Ayorajadichurna* over *loha bhasma* in the management of Pandu roga w s r toiron deficiency anaemia. Dept of KC, Belagavi. Ayorajadi churna 500 mg TIDafter food and Loha bhasma 500 mg (100mg+400 mg starch) capsule TID for 45 daysand concluded that subjective parameters like Panduta Daurbalya Arohanayasa Hrutspandana Shrama and objective parametersHb percentage ESR Peripheral smear Serum iron gradually.
DR subir kumar khan 2012 conductedstudy on Efficacy of Trikatrayadi Lauha in Panduroga with reference to IronDeficiency Anemia.And concluded that Trikatrayadi lauha given 250 mg QID for 2months and concluded that both groups shown significant effect on the signs andsymptoms of shrama shwasa daurbalya pandu varna hridspandana hatanala bhrama aruchi arohanaayasa shiroruja shotha and Hb serum iron.
**AIM AND OBJECTIVES**
**AIM**
To study the efficacyof *Vidangadi Loha* in *Anemia*
**OBJECTIVES**
To evaluate the efficacy of *VidangadiLoha* in the management of *IDA.*
To compare the efficacy of *VidangadiLoha* and Punarnava *Mandura* in IDA
**HYPOTHESIS**
**H0**
Effect of *vidangadi loha* and *punarnavamandura* on IDA are comparable
**H1**
Effect of *vidangadi loha* and *punarnavamandura* on IDA are not comparable
**RESEARCHQUESTION**
Whether *Vidangadi Loha* administration in the dose of 250mg BD for60 days will be effective in the management of IDA
**MATERIALS**
**Literary source**
The source of the data for the present study willbe 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 selectedfrom OPD/IPD of KLEs ayurvedic hospital and MRC Belagavi**.**
**Drug source**
*Punarnava mandura* will be procured from GMPcertified Ayurveda pharmacy
*Vidangadi loha* is prepared in GMP certifiedKLE Ayurveda pharmacy khasbhag Belagavi**.**
**METHODOLOGY**
**RESEARCH DRUG**
**Collection**
Authentication and quality assessed raw materials of *vidangadi loha*will be collected from GMP certified KLE Ayurvedapharmacy khasbhag Belagavi**.**
**Authentication**
ASU certified Authentication ofraw drugs will be obtained from Central Research Facility AYUSH approved drugtesting laboratory for ASU drugs KAHERsShri B M Kankanwadi Ayurveda Mahavidyalaya &Post Graduate studies Researchcentre BELGAVI
**Preperation**
All the ingredients will be taken in requiredquantity and preparation will be done as per SOPs
Procurement of ingredients of vidangadi loha from GMP certified KLEAyurveda pharmacy khasbhag Belagavi and Preparation of *vidangadi loha*will be carried out at GMP certified KLE Ayurvedapharmacy khasbhag Belagavi.
Procurement of *punarnavamandura* from GMP Certified Ayurveda pharmacy will be done.
**Analysis**
Final productwill be analysed at AYUSH approved drug testing laboratory for ASU drugs Govtof IndiaKAHERs Shri B M Kankanwadi Ayurvedamahavidyalaya & Research centre BELGAVI
**Packaging and Storing**
The trail drugwill be packaged in GMP certified KLE ayurvedic pharmacy, and stored in MRC KLEhospital Belagavi
**MAIN STUDY**
**CLINICAL STUDY**
After approval frominstitutional 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 comparabilityto *punarnava mandura* in the management of Iron Deficiency Anaemia
**GROUPS 2**
GROUP A :20
GROUP B: 20
**SAMPLE SIZE**
40
**GROUPS INTERVENTION**
| | | | | |
| --- | --- | --- | --- | --- |
|GROUP
SAMPLE SIZE
INTERVENTION
Anupana
DURATION
|Group A
Control
20
*Punarnava*
*Mandura* 250mg
Twice a day after food
Takra
60 days
|Group B
Trial
20
*Vidangadi loha* 250 mg twice a day
Guda
60 days
**DIAGNOSTIC CRITERIA:**
Presence of signs and symptoms of *pandu roga* like *pandutadaurbalya* *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* thatinclude *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 majorinterventions.
Any time during the study continuation of studydrug could lead to harmful affect.
Subjects failure to follow the instructions of theprincipal investigator.
Other administrative reasons.
**RESCUEMEDICATION**
Patients developing aggravation worsening ofpresent clinical condition would be referred to appropriate specialist centreand will be administered rescue medications. Such patients will be excludedfrom the study.
**STUDY SITE**
KLE AYURVEDA HOSPITAL MEDICAL RESEARCH CENTRE BELAGAVI.
**STUDY PERIOD**
18 months
**ASSESSMENT CRITERIA**
**SUBJECTIVEPARAMETERS** 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 30th 45thand 60th day.
Objective parameters will be assessed on baselineand 60th day.
**STATISTICAL METHODS TO ANALYSETHE DATA**
Assessment of Quantitativeparameters will be assessed in Within Group by Paired T test and BetweenGroups will be assessed by Independent sample T test. Assessment of Qualitativeparameters will be assessed in Within groups by Wilcoxon sign test and betweengroup will be assessed with Mann Whitney Test. Level of significance will be pis less than 0.05
**EXPECTED OUTCOME**
*Vidangadi loha* mayhelp in the improvement of symptoms like panduta daurbalyata etc of IDA.
**Does the study require anyinvestigation or intervention conducted on animals, patients or human**
Yes.
**ETHICAL CLEARANCE**yet to obtained
**CTRI NUMBER**yet to be registered
**BIBLIOGRAPHICREFERENCES**
Agnivesha charaka samhithaedited by Yadavjitrikamji acharya with ayurvedadika commentary bychakrapanidatta chaukamba prakashan Varanasi 2009 sutra 23 of 5 p 122
Khan SKVyas SN Chandola HM Efficacy of TrikatrayadiLauha 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 irondeficiency 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 etal The Efficacy and Safety of Vitamin C for Iron Supplementation in AdultPatients With Iron Deficiency Anemia ARandomized Clinical Trial. *JAMA Netw Open*. 2020;3(11):e2023644.Published 2020 Nov 2. doi:10.1001/jamanetworkopen.2020.23644
NingS, Zeller MP. Management of iron deficiency. *Hematology Am Soc HematolEduc Program*. 2019;2019(1):315-322. doi:10.1182/hematology.2019000034
Rupapara AV, Donga SB, Dei L. Acomparative study on the effect of Pandughnivati and Dhatrilauhavati in themanagement of Garbhinipandu (Iron Deficiency Anemia). Ayu. 2013Jul;34(3):276-80. doi: 10.4103/0974-8520.123120. PMID: 24501523
Khan SK, Vyas SN, Chandola HM. Efficacy of Trikatrayadi Lauha in Pandurogawith reference to Iron Deficiency Anemia. Ayu. 2012 Jan;33(1):62-7. doi:10.4103/0974-8520.100313. PMID: 23049186.
Pandya MG, Dave AR. A clinical studyof Punarnava Mandura in the management of Pandu Roga in old age (geriatricanemia). Ayu. 2014 Jul-Sep;35(3):252-60. doi: 10.4103/0974-8520.153735. PMID:26664234.
lalchandrajip,shri haridattashastri p,edition 8,baishajya ratnavali ofgovindadasvirachitha,panduroga chapter 10, verse 24.varanasi,2016,pg 225
Gupta KL, Pallavi G,Patgiri BJ, Galib, Prajapati PK. Critical review on the pharmaceutical vistasof Lauha Kalpas (Iron formulations). *J Ayurveda Integr Med*.2012;3(1):21-28. doi:10.4103/0975-9476.93944
KulkarniS, Mohanty N, Kadam NN, Swain N, Thakur M. Green Synthesis to Develop Iron-NanoFormulations and Its Toxicity Assays. *J Pharmacopuncture*.2020;23(3):165-172. doi:10.3831/KPI.2020.23.3.165
Rai S, KarAC. A review on role of psychological factors in the etiopathogenesis of *PanduRoga* with reference to iron deficiency anemia. *Ayu*.2016;37(1):18-21. doi:10.4103/ayu.AYU\_186\_13
Agnivesha,charaka samhithaedited by yadavjitrikamji acharya with ayurvedadipika commentary bychakrapanidatta, Charaka Chikitsasthana,chaukamba prakashan Varanasi2009,chapter 16,verse 3,4,13-1
Miller JL. Iron deficiency anemia: a common and curable disease. ColdSpring Harb Perspect Med. 2013 Jul 1;3(7):a011866. doi:10.1101/cshperspect.a011866. PMID: 23613366
NingS, Zeller MP. Management of iron deficiency. *Hematology Am Soc HematolEduc 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 (Ironformulations). *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
Muñoz M,Gómez-RamÃrez S, Bhandari S. The safety of available treatment options foriron-deficiency anemia. Expert Opin Drug Saf. 2018 Feb;17(2):149-159. doi:10.1080/14740338.2018.1400009. Epub 2017 Nov 20. PMID: 29103332.
Ning S, Zeller MP. Management of irondeficiency. *Hematology Am Soc Hematol Educ Program*.2019;2019(1):315-322. doi:10.1182/hematology.2019000034
Vidyadhar Shukla.Tripathi RaviDutt edited by Vaidyamanorama commentary,chaukamba Sanskrit pratishthan,charakasamhitha ,vol 2.pg407
P.V.Sharma,Dravya gunavignana,chaukambha Bharati academy,Delhi, 2006,part 2,Page. 693-728
Khan SK,Vyas SN, Chandola HM. Efficacy of Trikatrayadi Lauha in Panduroga withreference to Iron Deficiency Anemia. *Ayu*. 2012;33(1):62-67.doi:10.4103/0974-8520.100313
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
Patients presenting with clinical symptoms of pandu roga that include panduta daurbalya shrama Patients with Hb concentration of 7 –12 gm percentage of either gender.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SUBJECTIVE PARAMETERS suitable gradings of subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day panduta subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day Daurbalyata subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day Hrudspandanam subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day Shrama subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day Arohanayasa subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day LABORATORY PARAMETERS subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day Hb percentage subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day Peripheral smear subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day Serum iron subjective parameters will be assessed on baseline 30th day 45th day 60th day | objective parameters will be assessed on baseline and 60th day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
KAHERS shri BMK ayurvedic mahavidyalaya
🇮🇳Belgaum, KARNATAKA, India
KAHERS shri BMK ayurvedic mahavidyalaya🇮🇳Belgaum, KARNATAKA, IndiaDr N v sree chandanaPrincipal investigator9100468288sreechandana.kle21@gmail.com