A Clinical study to Evaluate the Efficacy of Shiva modakain the management of Malnutrition among School goingchildren

INTRODUCTION

Malnutrition is a mirror to the social status in which the people are living. It is a big challenge to the country. Malnutrition in growing children poses a major problem to the physical and mental development. Kuposhana/Bala Shosha is explained long back and many remedial measurements have been explained for the same in Ayurveda treatise. Shiva Modaka explained in Bhaishajya Ratnavali, BalaRoga Adhikara is selected for the present study Hence, present study has been done to bring out the best possible key to solve the malnutrition problem.

Materials & Methods

Materials

The ingredients of Shiva modaka were procured from genuine sources and the preparation was done at Dr. Krsna Muniyal life sciences Pvt ltd, Manipal.

Dosage: 5g single dose, empty stomach in the morning with milk

Duration of the study: 3 months during which BMI, anthropometric measurements, IQ level and subjective assessments were done on monthly basis. Hematological, Biochemical and Immunological investigations were done before and after the intervention.

Source of data: Patients fulfilling the diagnostic criteria of malnutrition were selected from government schools of Udupi district. A total of 60 students fulfilling the diagnostic criteria were selected for the study in a single group.

Inclusion criteria: The children between ages 5-10 years suffering from malnutrition were included in the present study on the basis of IAP criteria for diagnosis of PEM - Grade I: Patients with 71 – 80% of expected weight for age, Grade II: Patients with 61 – 70% of expected weight for age, Grade III: Patients with 51 – 60% of expected weight for age, Grade IV: Patients with < 50% of expected weight for age.¹

Exclusion Criteria: Cases with devitalizing diseases like Tuberculosis, Mal-absorption syndrome, Chronic diarrhoea, congenital heart disease, Mental retardation, Cerebral palsy, Mongolism, seizure and any sort of grave diseases.

Investigations: Haemoglobin percentage, lipid profile, serum protein, Immunoglobulin assay (Ig M and Ig A) were investigated Before and After Treatment.

Criteria for assessment of patients

The clinical evaluation of the patient was done by following particulars.

I. Objective assessment: The objective assessment was done on the basis of the

Investigation report of the patient, IQ level, BMI and the anthropometric measurements before and after the treatment.

II.Subjective assessment: The subjective assessment was made on the basis of signs and symptoms and divided in three groups as + Mild degree of sign and symptoms, ++ Moderate degree of sign and symptoms, +++ Severe degree of sign and symptoms.

Clinical Assessment of Result

The clinical study was analysed after the treatment as under.

Cure = 100% remission of sign and symptoms, Maximum improvement = 75-99% of remission of sign and symptoms, Moderate improvement = 50-74% of remission of sign and symptoms, Mild improvement = 25-49% of remission of sign and symptoms, No improvement = < 25% of remission of sign and symptoms.

Result

The Data collected from the study are grouped as under

Number of Subjects: 60

Mean Age of Subjects: 8.37 (yrs)

Mean of the values of various parameters are showed in the table which shows improvement in Hemoglobin percent, IQ, BMI, Height, Weight, Head circumference and Chest circumference. Total Protein, Lipid Profiles showed mixed results.

Discussion

Analysis of Data obtained by the clinical study shows that the individual data showed an Extreme Variation( Outline Values) in certain parameters such as Triglycerides, LDL cholesterol, VLDL Cholesterol, IgM and IgA. Though the intended Statistical tool initially suggested was Students’ Paired “T” Test, in case of Outline Values the calculated Mean is not all suitable. Hence, Wilcoxon’s Signed Rank Test was used for the above 5 parameters. The other parameters were analysed based on Paired “T” test.

Hemoglobin though showed some improvement after treatment, the Mean value Before treatment being 11.3162 and AT the Mean Hb being 12.0470 it was not statistically significant (P>0.05).

Total Cholesterol showed a borderline decrease in Mean values from 156.4 before treatment to 151.12 after treatment which was statistically significant (P<0.05).

Total Protein showed a slight reduction from mean value of 7.387 BT to 7.163 which was statistically significant (P<0.05).

IQ level showed a borderline increase from Mean 86.4 BT to 87 AT and the improvement was statistically significant (P<0.05).

Mean value of Body Mass Index (BMI) before treatment was 13.1168 which increased to 15.0320 and the improvement was statistically significant(P<0.05).

The Mean Height before treatment was 121.992 cm which increased to 123.217 cm and was statistically significant (P<0.05) The change in Weight from Mean Value of 19.418 before treatment to 22.383 after treatment was statistically significant (P<0.05).

Head circumference changed from the mean value of 50.4 before treatment to 50.683 after treatment which was statistically significant (P<0.05).

The Chest circumference improved slightly from a mean value 61.908 before treatment to 62.300 after treatment which was statistically significant (P<0.05).

The parameters such as Triglyceride, LDL, VLDL, IgM and IgA with Extreme (Outline) Values were subjected to Wilcoxon’s Signed Rank Test and 2-tailed test which showed that the results were significant and the variability of the values in these parameters reduced significantly after treatment.

Overall assessment of improvement in IAP scale and Symptoms suggested 80.5% of the subjects obtained significant relief of symptoms with treatment and about 19.5% obtained moderate relief.

Conclusion

The study concludes that the drug Shiva Modaka is very beneficial in the management of Malnutrition in the school going children of age 5-10 years. It significantly relieved the symptoms of Malnutrition and other associated symptoms and also helped to improve the immunological status and promoted the growth. Thereby the BalaRogaghna, Balya, Brimhana, Medhya effect stands proved justifying the selection of the drug here for this study.