Journal of Ayurveda and Integrated Medical Sciences

2025 Volume 10 Number 6 JUNE
Publisherwww.maharshicharaka.in

A comparative clinical study to evaluate the efficacy of Amalakyavaleha and Devdali Churna in Pandu Roga w.s.r. to Iron Deficiency Anemia in Children

Shah B1*, Minakshi2, Sharma R3
DOI:10.21760/jaims.10.6.3

1* Bimal Shah, Post Graduate Scholar, PG Department of Kaumarbhritya, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Himachal Pradesh, India.

2 Minakshi, Professor, PG Department of Kaumarbhritya, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Himachal Pradesh, India.

3 Rakesh Sharma, Professor and Head, PG Department of Kaumarbhritya, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Himachal Pradesh, India.

Background: Pandu Roga is a condition characterizes by skin discoloration resembling Haridra or a greenish tinge, along with symptoms such as Hridayaspandanam, Roukshyam, Swedabhava, Shrama and related complications. It reflects various underlying conditions caused by a deficiency in Rakta Dhatu, such as reduced hemoglobin or RBCs. Iron Deficiency Anemia (IDA), a prevalent nutritional disorder globally, affects over 40% of children, especially in developing nations like India. IDA impairs cognitive and physical development, immunity, and overall health. While iron supplements are commonly used, their side effects often limit adherence, highlighting the need for safer, holistic treatments.

Aim and Objectives: To evaluate, compare the efficacy and clinical safety of Amalakyavaleha and Devdali Churna drugs in children.

Materials and Methods: A randomized, comparative clinical trial was conducted on 40 pediatric patients for 4 weeks diagnosed with IDA. The patients were divided into two groups: Group I received Amalakyavaleha, while Group II was treated with Devdali Churna. The clinical efficacy of both interventions was assessed based on subjective and objective criteria, symptomatic relief, and overall improvement in nutritional status.

Results: The study revealed that both groups significantly improved clinical symptoms and hematological markers. The comparative analysis demonstrated the potential of Amalakyavaleha in addressing the underlying causes of Pandu Roga and effectively managing IDA.

Conclusion: This study seeks to provide evidence for using safe and effective Ayurvedic alternatives in addressing anemia in children, offering a holistic approach that goes beyond symptom management to target the root cause.

Keywords: Pandu Roga, Rakta Dhatu, IDA, Amalakyavaleha, Devdali Churna

Corresponding Author How to Cite this Article To Browse
Bimal Shah, Post Graduate Scholar, PG Department of Kaumarbhritya, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Himachal Pradesh, India.
Email:
Shah B, Minakshi, Sharma R, A comparative clinical study to evaluate the efficacy of Amalakyavaleha and Devdali Churna in Pandu Roga w.s.r. to Iron Deficiency Anemia in Children. J Ayu Int Med Sci. 2025;10(6):13-21.
Available From
https://jaims.in/jaims/article/view/4191/

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2025-05-05 2025-05-23 2025-06-03 2025-06-13 2025-06-23
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None Nil Yes 11.36

© 2025 by Shah B, Minakshi, Sharma R and Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

Download PDFBack To ArticleIntroductionAims and ObjectivesMaterials and MethodsResultsDiscussionConclusionReferences

Introduction

In our classical texts, Pandu Roga is one among the diseases which occurs due to Dhatu Vaishamyata and the description is available in three forms; i.e. as a disease,[1] complication[2,3,4] and sign of certain diseases.[5,6] The disease condition in which the skin of the person is discolored like Haridra or greenish tinge and other peculiar signs and symptoms include Hridayaspandanam, Roukshyam, Swedabhava, Shrama and its consequences.[7] Considering Panduta (Pallor) as the predominant sign, the disease is termed as Pandu Roga. In Charaka Samhita, it is mentioned as Pitta Pradhan Vyadhi and the Dosha Pitta Pradhanastu mentioned as its basic cause and Rasa Pradoshaja Vyadhi.[8]

Anemia is derived from the Greek term ‘bloodlessness’. It is defined as decreased red blood cell (RBC) volume (reflected by RBC count and Hb concentration per RBC and Hematocrit) or reduced Hb concentration below age-appropriate normal values. WHO defines “as a condition in which the number of RBCs is insufficient to meet the body’s physiologic needs”. It is not a disease entity but a manifestation of different diseases in which there is pallor on the skin due to a deficiency of blood tissue (Rakta Dhatu) either in the form of hemoglobin or red blood cells (RBCs).[9]

WHO (2011) estimated that the worldwide prevalence of anemia was 42% in children, 38% in pregnant woman and 29% in non-pregnant woman. Globally, it is estimated that 40% of all children aged 6–59 months, 37% of pregnant women and 30% of women 15–49 years of age are affected.[10]

Iron deficiency was the fourth and twelfth leading cause of years lived with disability in women and men observed by the Global Burden of Diseases Study in 2017. The percentage of years lived with disease has decreased over the past three decades from 17.3 to 12% in India.[11] The prevalence is significantly higher in developing countries as compared with developed countries. As per National Family Health Survey - 4 prevalence is highest in preschool children (>60%) followed by adolescents and young adults (30%).[12] IDA is most common and widespread nutritional deficiency anemia[13] in which reduction of iron stores precedes and is more severe condition in which low level of iron are associated with presence of microcytic hypochromic red cells in circulation,

the relative number of which reflects the severity of the iron deficiency. Iron helps to move oxygen from the lungs to the rest of the body and helps muscles store and use oxygen. In older children, it is usually caused by dietary deficiency, insufficient iron intake, poor gastrointestinal absorption or occult blood loss, intercurrent infections such as Hookworm infestation, Malaria, Infectious diseases, Tuberculosis, etc.

Pica also increases the risks of lead poisoning and helminthic infestation. Weakness, fatigue, shortness of breath, difficulty in concentrating and poor work productivity are non-specific symptoms attributed to low delivery of oxygen to body tissues and decreased activity of iron-containing enzymes. It has been reported to decrease cognitive performance and delay mental and motor development in children. Prematurity, living in poverty, a diet low in iron and certain long-term illnesses are the high-risk factors causing IDA in children.

Various formulations have been described in our classical texts, which are very effective in the prevention and management of Pandu Raga. Considering this, the present study “A Comparative Clinical Study to Evaluate the Efficacy of Amalakyavaleha and Devdali Churna in Pandu Roga w.s.r to Iron Deficiency Anemia in Childrenhas been focused on treatment of Pandu Roga.

Aims and Objectives

1. To analyze the etiopathogenesis of Pandu Roga and Iron Deficiency Anemia from Ayurvedic and Modern texts/ journals.
2. To evaluate the efficacy of Amalakyavaleha and Devdali Churna.
3. To compare the effects of Amalakyavaleha and Devdali Churna.
4. To evaluate the clinical safety of Amalakyavaleha and Devdali Churna drugs in children.

Materials and Methods

Total 40 patients were registered from the Kaumarbhritya-Balroga OPD/IPD, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, randomly fulfilling the criteria of this study. A case proforma was filled with the data obtained by interrogation, physical examination, and collection of details of each child.


Inclusion Criteria

1. Patient between age group of 3-12 years.
2. Patient having Hb in between 7-10 gm%. (as per WHO classification)
3. Patients / Parents willing to participate in the trial.

Exclusion Criteria

1. Patients having age less than 3 years and above 12 years.
2. Patient having Hb levels below 7 gm% or above 10 gm%.
3. Patient suffering from the major systemic illness, Tuberculosis, Bleeding Disorders, etc.

Grouping of patients

In the present research work, a total of 40 patients were registered and studied under two groups.

Group I: In this group, 20 patients were managed with Amalakyavaleha.

  • Route of Administration: Oral
  • Dosage: 500mg/kg/day in two divided doses.
  • Anupana: Lukewarm Water.

Group II: 20 patients were managed with Devdali Churna in this group.

  • Route of Administration: Oral
  • Dosage: 80mg/kg/day in two divided doses.
  • Anupana: Lukewarm milk or water.

Duration of the trial: 4 weeks

Follow up: 2nd week and at the time of completion.

Criteria of Assessment of Results

The assessment of the effect of trial drugs was done based on the subjective and objective criteria. All the patients were examined before initiation and after completion of the trial.

The improvement was assessed based on relief in the severity of the symptoms and changes in the laboratory investigations were also taken into consideration.

Subjective Criteria

Grading and scoring system were adopted for assessing each sign and symptom before the commencement and after completion of trial.


SNSymptomsGrade
1.Panduta - Twacha(1), Nakha(2), Netra(3), Jihwa(4), Hastapada(5)
Absent0
Present at one site1
Present at two sites2
Present at three or more sites3
2.Daurbalya (Weakness)
Not present0
After Moderate work, relieved soon and tolerable1
After moderate work, relieved later and tolerable2
After little work, relieved later and beyond tolerable3
3.Hridayaspandanam (Palpitation)
Not present0
On doing routine physical activity1
On doing strenuous physical activity2
4.Aruchi (Anorexia)
Absent0
Present1
5.Bhrama (Dizziness)
No0
Mild1
Moderate2
Severe3
6.Ayasaja Shwasa (Shortness of breath)
No0
Mild1
Moderate2
Severe3


7.Shirashoola (Headache)
No0
Mild1
Moderate2
Severe3
8.Pica
Not present0
Present1
9.Disturbed Sleep
Not present0
Present1
10.Pindikodweshtana (Calf Muscle Pain)
Not Present0
Present1

Objective Criteria

  • Hb gm%
  • Ferritin
  • Peripheral Blood Smear

Laboratory investigations

  • MCV, MCH, MCHC
  • TLC
  • ESR
  • RFT (Blood Urea, S. Creatinine)
  • LFT (SGOT, SGPT)

Statistical Analysis

Proposed research work was an open-label clinical trial. Data was statistically analysed by using appropriate tests “Student’s paired ‘t’ test” for individual group & “Unpaired ‘t’ test” for intergroup comparison were used for parametric data.

For non-parametric data “Wilcoxon signed rank sum test” was used for individual group and “Mann Whitney ‘U’ test” was used for intergroup comparison.

The obtained results were interpreted as follows

  • Highly significant p<0.001
  • Significant p<0.05
  • Insignificant p>0.05

Assessment of Results

Result is assessed based on overall effect of trial drug on subjective and objective parameters and categorized as

Marked Improvement>75% Relief
Moderate Improvement50%-74% Relief
Mild Improvement25%-49% Relief
No Improvement<25% Relief


Results

Assessment of the subjective parameters before and after treatment

Signs and symptomsGroupsMeand% ReliefSD±SE±W valueP value
BTAT
PandutaGroup I1.650.70.9557.57%0.6040.135-136<0.001
Group II1.70.750.9555.88%0.2230.05-190<0.001
DaurbalyaGroup I1.60.6162.50%0.4580.102-171<0.001
Group II1.650.61.0563.63%0.2230.05-210<0.001
Hridaya spandanamGroup I10.450.5555%0.6040.125-550.002
Group II0.750.40.3546.67%0.4890.109-280.016
AruchiGroup I0.950.10.8589.47%0.3660.081-153<0.001
Group II0.90.10.888.89%0.4100.091-136<0.001
BhramaGroup I1.050.40.6561.90%0.5870.131-78<0.001
Group II1.20.550.6554.17%0.5870.131-78<0.001
Ayasaja ShwasaGroup I0.850.40.4552.94%0.5100.114-450.004
Group II0.650.350.346.15%0.4700.105-210.031


ShirashoolaGroup I1.60.70.956.25%0.4470.1-153<0.001
Group II1.40.50.964.28%0.3070.068-171<0.001
PicaGroup I0.90.10.888.88%0.4100.091-136<0.001
Group II10.350.6565%0.4890.109-91<0.001
Disturbed sleepGroup I0.950.10.8589.47%0.3660.081-153<0.001
Group II0.60.250.3558.33%0.4890.109-280.016
PindikodweshtanaGroup I0.750.30.4560%0.5100.114-450.004
Group II0.60.150.4575%0.5100.114-450.004

Intergroup comparison of sign and symptoms

Signs and symptomsMean diff. (BT-AT)Diff. in % ReliefMann Whitney Rankp value
Group IGroup II
Panduta0.950.951.69%408.50.978
Daurbalya11.05-1.13%3920.634
Hridayaspandanam0.550.358.33%443.50.371
Aruchi0.850.80.58%4200.796
Bhrama0.650.657.73%4100.989
Ayasaja Shwasa0.450.36.79%4400.423
Shirashoola0.90.9-8.03%4090.989
Pica0.80.6523.88%4400.423
Disturbed sleep0.850.3531.14%5100.007
Pindikodweshtana0.450.45-15%4100.989

Effect of Therapy on Objective Criteria

InvestigationsGroupsMeand% changeSD±SE±‘t’ valuep value
BTAT
Hb gm%Group I9.4069.84-0.434-4.61%0.8520.191-2.2770.035
Group II9.4159.56-0.145-1.54%0.3680.082-1.7630.094
S. FerritinGroup I32.57434.335-1.761-5.41%2.6430.591-2.9800.008
Group II28.80129.631-0.831-2.88%2.9040.649-1.2800.216

Intergroup comparison of Objective criteria

InvestigationsMean diff (BT-AT)Diff. in % Relief‘t’valuep value
Group IGroup II
Hb gm%-0.434-0.145-3.07%-1.3920.172
S. Ferritin-1.761-0.831-2.53%-1.0590.296

Intergroup Comparison for Peripheral Blood Smear

PBFBTATPercentage
Mild Microcytic HypochromicPoikilocytosis and AnisocytosisNormocytic Normochromic
No. of Pt.No. of Pt.No. of Pt.
Group I1821680.00%
Group II2001365.00%

Effect of Therapy on Laboratory parameters

InvestigationsGroupsMeand% changeSD±SE±‘t’ valuep value
BTAT
TLCGroup I7.1586.1630.99513.90%1.5560.3482.8590.010
Group II5.975.8160.1542.58%0.7280.1630.9490.355
MCVGroup I77.0780.35-3.3-4.28%2.4730.5535.968<0.001
Group II75.6577.5-1.85-2.45%1.3090.293-6.321<0.001
MCHGroup I22.723.1-0.4-1.76%0.9950.222-1.7980.088
Group II22.8523.05-0.2-0.88%0.5230.117-1.7100.104
MCHCGroup I28.429.05-0.65-2.29%0.5870.131-4.951<0.001
Group II28.4528.95-0.5-1.76%0.5130.115-4.359<0.001
ESRGroup I14.2512.451.812.63%5.4731.2241.4710.158
Group II15.6514.451.27.67%5.1771.1581.0370.313


SGOTGroup I26.25251.254.76%5.0561.1311.1060.283
Group II29.528.051.454.92%5.961.3331.0880.290
SGPTGroup I19.119.7-0.6-3.14%6.2861.406-0.4270.674
Group II23.522.051.456.17%7.031.5720.9220.368
S. CreatinineGroup I0.7050.6050.114.18%0.1650.0372.7030.014
Group II0.660.5850.07511.36%0.1680.03761.9940.061
B. UreaGroup I24.321.352.9512.14%6.7781.5161.9460.067
Group II25.322.852.459.68%6.5491.4641.6730.111

Intergroup comparison of laboratory investigations

InvestigationsMean diff (BT-AT)Diff. in % Relief‘t’ valuep value
Group IGroup II
TLC0.9950.15411.32%2.1880.035
MCV-3.3-1.851.83%-2.3180.026
MCH-0.4-0.2-0.88%-0.7960.431
MCHC-0.65-0.5-0.53%-0.8600.395
ESR1.81.24.96%0.3560.724
SGOT1.251.45-0.16%-0.01140.909
SGPT-0.61.45-9.31%-0.9720.337
S. Creatinine0.10.0752.82%0.4740.638
B. Urea2.952.452.46%0.2370.814

Discussion

Subjective parameters

  • The study revealed excellent results in Group I, where patients showed relief in symptoms such as Panduta, Daurbalya, Aruchi, Bhrama, Shirashoola, Pica and Disturbed sleep with highly significant statistical results (p<0.001). There were also significant improvements in Hridayaspandanam, Ayasaja Shwasa and Pindikodweshtana (p<0.05).
  • Group II also showed satisfactory outcomes, with significant improvement in Hridayaspandanam, Ayasaja Shwasa, Disturbed sleep and Pindikodweshtana. However, highly significant relief was observed in symptoms of Panduta, Daurbalya, Aruchi, Bhrama, Shirashoola and Pica.
  • When comparing the two groups, Group I exhibited superior improvement across all subjective assessment parameters.

Objective parameters

  • The differences in mean values of the objective parameters like Hb, MCH, MCHC, ESR, SGOT, SGPT, S. Creatinine, B. Urea, S. Ferritin before and after treatment were not statistically significant, suggesting the possibility of chance occurrence. However, TLC and MCV showed statistically significant mean differences.

Probable Mode of Action of the Trial Drugs.

1. Amalakyavaleha

Pharmacological Actions

IngredientsKarmaAction based on pharmacological studies
AmalakiRaktavikara, Paittikavikara, Daurbalya, Rasayana, DeepanaAntioxidant, Anti-inflammatory Immunomodulator, Hepatoprotective, Intestinal disorders, Antibacterial, Cytoprotective
PippaliPandughna, Daurbalya, Aruchi, Deepana, Raktavardhaka, RasayanaAntioxidant, Antibacterial, Antimicrobial and Anti-amoebic, Anthelmintic, Antiplatelet
YashtimadhuVatapittashamaka, Raktavikara, Raktalpata, Rasayana, BalyaAntioxidant, Anti-inflammatory, Anti-microbial, Immunostimulatory, Hepatoprotective
DrakshaPandughna, Hrida Daurbalya, Anulomana, RaktaprasadanAntioxidant, Antimicrobial and Anti-viral, Hepatoprotective, Cardioprotective
ShringaberaHridya, Deepana, Pachana, Vatanulomana, Daurbalya, RaktavardhakaAntioxidant, Neuroprotective & cognitive-enhancing effects, Hepatic & renal-protective effect
VamshalochanRaktavikara, Raktasthambhaka, BalyaAntioxidant, Anti-inflammatory, Anthelmintic, Antibacterial
SharkaraPittashamaka, Raktavardhaka, Balya, Daha Prashamana, Balya, DeepanaAnti-inflammatory, Antipyretic, Digestive Aid
MadhuAgni Deepaka, Balya, Lekhaniya, Shodhana, Krimivishaprashamana, TridoshaprashamanaAnti-bacterial, Antioxidant property, source of Dietary fiber, Vit C, Vit.B6

Therapeutic Indication

SNTherapeutic indicationDrug ingredientsImprovement in Clinical Features
1.PandughnaDraksha, Pippali, AmalakiPaleness, Headache
2.DaurbalyaAmalaki, Pippali, ShringaberaFatigue, Weakness, Shortness of Breath, Dizziness
3.Deepana-PachanaAmalaki, Pippali, Sharkara, Madhu,Anorexia, Disturbed Sleep
4.RaktvardhakaAmalaki, Pippali, Yashtimadhu, Draksha, Shringabera, SharkaraWeakness, Palpitations, Calf muscle pain, Disturbed Sleep, Anorexia, Pica, Headache
5.Hrida DaurbalyaAmalaki, Draksha, Pippali, ShringaberaPalpitations, Shortness of breath, Dizziness
6.VatanulomanaDraksha, ShringaberaCalf muscle pain, Headache, Disturbed Sleep
7.PittashamakaAmalaki, Yashtimadhu, Shringabera, Sharkara, MadhuAnorexia, Palpitations, Dizziness
8.BalyaYashtimadhu, Vamshalochana, Sharkara, MadhuWeakness, Calf muscle pain, Dizziness
9.KrimivishaprashamanaPippali, MadhuPica, Anorexia
10.AruchiAmalaki, Pippali, Shringabera, MadhuAnorexia, Weakness

jaims_4191_01.JPG
Flow chart 1: Samprapti Vighatana of Pandu Roga by Amalakyavaleha

2. Devdali Churna

Pharmacological Actions

IngredientsKarmaAction based on pharmacological studies
DevdaliRaktavikara, Paittikavikara, Daurbalya, Rasayana, DeepanaAntioxidant, Anti-inflammatory Immunomodulator, Hepatoprotective Intestinal disorders, Antibacterial Cytoprotective

Therapeutic Indication

SNTherapeutic indicationDrug ingredientImprovement in Clinical Features
1. Raktavikara, Paittikavikara, Daurbalya, Rasayana, DeepanaDevdaliPica, Disturbed Sleep, Anorexia, Headache, Dizziness

jaims_4191_02.JPG
Flow chart 2: Samprapti Vighatana of Pandu Roga by Devdali Churna


  • The selected formulations for the study i.e., Amalakyavaleha and Devdali Churna possess excellent Pandughna Karma with Amla, Madhura, Katu, Tikta Rasa, Laghu, Ruksha, Snigdha Guna, Sheeta and Ushna Virya with Madhura and Katu Vipaka
  • The constituent herbs of both the formulations are collectively known to have Antioxidant, Anti-inflammatory, Anti-microbial, Immunomodulatory, Hepatoprotective, Antibacterial, Antimicrobial and Anti-amoebic, Anthelmintic, Antiplatelet, Cytoprotective, source of Dietary fiber, Vit C, Vit.B6, Digestive Aid effects based on pharmacological evidence-based studies, play a crucial role in Disrupting the pathogenesis of the disease.

Conclusion

Pandu Roga is a widespread nutritional disorder in children characterized by Fatigue, Paleness and General weakness. These symptoms can significantly hinder a child’s growth and daily activities, presenting a challenge for parents who must balance their child’s nutritional needs with frequent medical care, often leading to emotional stress.

Ayurvedic remedies have proven effective in reducing the severity of Pandu Roga in children. Whether it comes to alleviating the symptoms like Panduta, Hridayaspandanam, Bhrama, Pica, Pindikodweshtana as well as associated features like Weakness, Anorexia, Headache and Disturbed Sleep.


The study indicates that the Amalakyavaleha formulation administered in Group I had more satisfactory and significant results compared to the drug used for Group II. No adverse effects were reported during the trial, confirming the safety of both treatments.

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