A CLINICAL STUDY IN THE MANAGEMENT OF PANDU (IRON DEFICIENCY ANAEMIA) WITH AN INDIGENOUS COMPOUND

Dr. Adarsh P. Assistant Professor Department of Roga Nidana, K.J. Institute of Ayurveda and Research and Kashiba Ayurveda Hospital, Savli, Vadodara, Gujarat. ...................................................................................................................... Manuscript Info Abstract ......................... ........................................................................ Manuscript History Received: 07 April 2020 Final Accepted: 10 May 2020 Published: June 2020

The causes of Iron Deficiency Anaemia are insufficient dietary intake and improper absorption of iron which causes symptoms such as feeling of weakness, tiredness, shortness of breath, palpitations, koilonychia, glossitis, dysphagia and altered sensation of taste 8,9 . The modern management of Iron Deficiency Anaemia is to find out and treat the underlying cause and to give iron to correct the anaemia. The best preparation of oral iron is Ferrous Sulphate which is given at a dose of 100mg twice daily. But this has many adverse effects like nausea, diarrhoea, dyspepsia, constipation etc.
Ayurveda being holistic medicine advises that all diseases are due to malfunction of Agni (metabolism). If metabolism is good everything gets digested and assimilated, which is necessary for the sustaining the health. Both Ayurveda and contemporary science accepts the fact that derangement of Agni (metabolism) is the root cause of the disease. As a result of weakened Agni an intermediate product of metabolism called Ama is formed. This Ama causes diseases like Pandu.
Pandu being a SantarpanajanyaVikara, requires TeekshnaOushadies like Loha to break the Samprapthi 10 . Contemporary science also accepts the facts that disturbed absorption along with dietary insufficiency is the root cause for Iron Deficiency Anaemia. Even though Ayurveda and modern science utilizes iron in Pandu (Iron Deficiency Anaemia) but intentions are grossly different.
Here is a novel approach to manage Pandu (Iron Deficiency Anaemia) without using iron as a direct supplement. Selected compound consisting of ingredients Nimba, Daruharidra, Punarnava, Triphala, Trikatu, Hareetaki, Shilajith, Badara does not contain iron as an direct ingredient thus averting the adverse effect of oral iron therapy such as constipation, fatigue, loss of appetite, weakness etc 11,12 .

Aims and Objectives:-
The present study was taken up with following aims and objectives. Koppa along with its associated hospitals and MSDM Government hospital, Koppa were selected for the study. The study was conducted from December 2014 to August 2015. Subjects diagnosed with Pandu (Iron Deficiency Anaemia) were incidentally selected and randomly categorized into two groups, each consisting at least 20 subjects using simple randomization based on incidence. Complete details of the clinical trial and the rights of the participant were explained and informed consent was obtained from each participants or guardians of the participants. From the Institutional Ethical Committee clearance has been obtained for the study.

Criteria for selection of patients: Inclusion Criteria:
Patients diagnosed with Pandu (Iron deficiency Anaemia) from either sex within the age group of 20 -60 years and Hb% within the rangeof 7-12gm/dl in males and 7-11gm/dl in females was selected 13 .

Exclusion Criteria:
Patients with history of systemic diseases like diabetes mellitus and hypertension, pregnant and lactating women, subjects with abnormal hemopoiesis like megaloblastic anaemia, unusual haemolysis due to red cell membrane defects, hereditary spherocytosis, hereditary elliptocytosis, and malaria, auto immune haemolyticanaemia, unusual blood loss like gastro intestinal bleeding, physical trauma, haemoglobinopathies like sickle cell anaemia, leukemia, thalassaemia and patients with infectious diseases were excluded.

Laboratory investigations:
Following laboratory blood investigations was used in the study Hb%, MCH, MCV, PCV, MCHC for diagnosis and assessment of Iron Deficiency Anaemia.  HridayaSpandanadhikya Absent 0 Present only during some exercise that subsides itself on rest 1 Present during the normal routine activities that subsides itself on rest 2 Present during the normal routine activities but doesn't subside on rest 3 15 Gauravam Absent 0 Feeling Gauravam once or twice in a day without affecting the normal routine work 1 Feeling Gauravam throughout the day without affecting the normal routine work 2 Sample size: Out of 60 patients of Pandu (IDA) screened for eligibility, 47 were incorporated in to clinical trial. Among them, seven failed to follow-up hence declared as dropped out. None were withdrawn in the middle of the trial duration.

Statistical Methods:-
The data was statistically analysed using paired and unpaired Students, T test.

Observation and Results:-
In the study more than 60 patients diagnosed with Pandu (Iron Deficiency Anaemia) were screened for the eligibility and 47 were selected. Seven were dropped out for nonspecific reasons especially failure to follow up. 20 patients completed the study in each group. The observations were made on the basis of clinical findings.

Results:-
Following are the results obtained in the patients of Pandu Roga on administration of Capsule Indigenous Compound per the defined protocol. Parameters of assessment were scored at base line (BT) and after completion of the treatment. The data was processed for student's t test using Sigma stat 3.5. The results have been presented below.

Effect of therapy on Daurbalyam:
In the subjective parameter of Daurbalyam, Capsule Indigenous Compound drug exhibited 66.6% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 64.4% improvement.

Effect of therapy on ArohanaAayasa:
In the subjective parameter of ArohanaAayasa, Capsule Indigenous Compound drug exhibited 47.6% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 56% improvement

Effect of therapy on Bhrama:
In the subjective parameterBhrama, Capsule Indigenous Compound drug exhibited 64.5% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 70% improvement.

Effect of therapy on Hrudrava:
In the subjective parameterHrudrava, Capsule Indigenous Compound drug exhibited 61.5% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 59% improvement.

Effect of therapy on Karnakshweda:
In the subjective parameterKarnakshweda ,Capsule Indigenous Compound drug exhibited 52% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug also showed 52% improvement.

Effect of therapy on Aruchi:
In the subjective parameterAruchi ,Capsule Indigenous Compound drug exhibited 94% improvement after 60 days of treatment which is statistically highly significant with p value <0.001.Control drug also showed 94% improvement.

Effect of therapy on Agnimandya:
In the subjective parameterAgnimandya, Capsule Indigenous Compound drug exhibited 71% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 57% improvement.

Effect of therapy onHrudayaspandanadhikya:
In the subjective parameter HrudayaSpandanadhikya, Capsule Indigenous Compound drug exhibited 50% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 55% improvement.

Effect of therapy onPCV:
In the subjective parameter PCV, Capsule Indigenous Compound drug exhibited 16% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 11% improvement.

Effect of therapy onMCV:
In the subjective parameter MCV, Capsule Indigenous Compound drug exhibited 12% improvement after 60 days of treatment which is statistically highly significant with p value <0.001. Control drug showed 8% improvement.

Discussions:-
Forty-Seven patients were eligible for the study in which 7 were dropped in between. The study was conducted on 40 patients, 20 patients were put on trial group rest 20 patients in control group selected from the OPD & IPD of A.L.N. Rao Memorial Ayurvedic Medical College and hospital, Koppa along with its associated OPDs. For the optimum dose fixation patients within the age group of 20 to 60 were selected because the dosage varies for Bala and Vruddha. The range of haemoglobin for the selected patients was between 7-12g/dl in males and 7-11g/dl in females because haemoglobin below 7gm/dl needs emergency intervention 13 . Maximum numbers of patients in the study were observed between the ages 20 to 40. It might be due to heavy work and low food intake and menstruation in females and constant hard work and mental tension in males 14 . 95% of patients in the trial group and 90% in control group were women this might be due to fewer intakes of iron, menstrual bleeding, mental tension and malnutrition 14 . 50% of the patients were graduates in both groups and remaining 50% belong to illiterate, primary school and high school. This might be due to less awareness regarding health and disease 14 . 55% of subjects from trial group and 60% from control group were vegetarians followed by mixed diet. Vegetarians are prone to iron deficiency anaemia because iron salts in vegetables are less absorbed in GIT 15 . Majority of patients were from poor class 50% of subjects in trial and 60% in control group were from poor class. This might be due to the unavailability of nutritious food and unhygienic conditions 14 . 50% of patients in trial group and 60% in control group were addicted to tea, 35% and 25% of patients respectively in etc group were addicted to coffee. Rests of the patients were addicted to smoking and alcohol. The phenols in tea reduce the absorption of iron from GIT 16 . Smoking and alcohol affect the digestive process leading to less absorption of iron from GIT. The trial drug as well as control drug yielded statistically highly significant results in Dourbalya, Srama, Aarohanaayasa, Panduta,Bhrama, Hrudrava, Karnakshweda, Aruchi, Agnimandya, Shunkshikutashotha, Sirnalomata, Pindikodweshtanam, Tamaha-darsana, Hridayaspandanadhikya, and Gouravawith p<0.001 with 95% confidence interval. Both yielded statistically highly significant results with p value <0.001 in objective parameters like Hb %, PCV, MCV, MCH, and MCHC also. In objective parameters trial drug percentage wise showed marginally better improvement than control drug.  19 . Fruits of Badara are very rich in vitamin C, antioxidants, iron, vitamin B12 and it is stated that a single fruit contains enough vitamins advised by WHO for an adult. It has also got hepatoprotective, immunomodulation and cardiotonic action 20 . Punarnava contains iron; it has also got hepatoprotective immunomodulation and cardiotonic action 21 .
Pipali is rich in vitamin C and it has hepatoprotective immunomodulation and cardiotonic action 22 . Pipali also enhances absorption in small intestine. Maricha enhances the absorption of iron in small intestine and is rich in vitamin C and B complex 23 . Shunti is rich in vitamin B complex, vitamin C and has got hepatoprotective immunomodulation and cardio tonic action. Minimum quantity of Shunti in diet has increased absorption in GIT and relieved constipation 24 . Amalakiis very rich source of vitamin C, and iron. It has got hepatoprotective and cardioprotective action 25 . Research works showed that Haritaki has enhanced absorption in small intestine 26 . Vibheetaki is having antioxidants, vitamin C, B complex and iron. It also showed hepatoprotective action 27 . Shilajit contains vitamin C, B complex, iron and other metals in trace quantities. Moreover, it is found that if Shilajit is given along with vitamin C or any minerals it enhances the bioavailability of that minerals.
Liver plays an important role in iron metabolism. Iron is stored in the liver as ferritin and hemosiderin which is utilized for the synthesis of new haemoglobin. Bile is a necessary factor for the absorption of iron from the small intestine. Gastric juices convert ferrous iron to ferric iron which is transported by a protein called ferroportin. This ferric iron combines with globin and it is released into the blood. This cycle is governed by liver enzyme called apotransferin released through bile. If we analyse the drugs in the Cap Indigenous Compound most of the drugs are hepatoprotective, hepato-stimulant in action which might have enhanced bile secretion and the absorption of iron from GIT.
Drugs like Nimba, Punarnava, Vibheetaki, AmalakiandShilajit has iron in good quantity and drugs like Hariaki, Pipali, Maricha and Shunti has enhanced intestinal absorption and motility, relieving constipation. Vitamin C present in the drugs might have enhanced iron absorption and might have prevented the formation of insoluble iron compounds and reduction of ferric iron to ferrous iron. Presence of Silajith might have increased the bio availability of iron and vitamins in this combination, which might have enhanced the action of the drug.