|CLINICAL STUDY: ORIGINAL ARTICLE
|Year : 2021 | Volume
| Issue : 3 | Page : 170-180
Study of pattern of morbidity in children under 5 years and effect of Swarnaprashan on morbidity status
Nitu Sinha1, Nisha Kumari Ojha2
1 Department of Kaumarbhritya, Shree Ram Ayurvedic Medical College and Hospital, Meerut, Uttar Pradesh, India
2 Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur, Rajasthan, India
|Date of Submission||16-Sep-2020|
|Date of Decision||19-Jan-2021|
|Date of Acceptance||19-Jan-2021|
|Date of Web Publication||25-Sep-2021|
Department of Kaumarbhritya, Shree Ram Ayurvedic Medical College and Hospital, Meerut, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: Infant and child mortality and morbidity remain a challenge especially in the developing world. More than half of the children (53.7%) are suffering from some form of illness. Recurrent respiratory infection, recurrent diarrhea, recurrent fever, etc. are the most common causes of morbidity in immune-compromised children. In India, 15% of death occurs during infancy and 1-5 years of age are due to respiratory infections. Diarrhea constitutes the most important cause of chronic morbidity followed by malnutrition. The objective of this research was to study the effect of swarnaprashan on morbidity status of the children under five years of age. Methods: A randomized, open-label study was conducted on 60 children of 06 months to 5 years of age and were randomly divided into two groups (30 in each). In Group A, trial drug (Swarnaprashan) was given and in Group B, there was regarded as 'No treatment concurrent control'. Results: In group A where trial drug (Swarnaprashan) was given, improvement in morbidity features were found whereas in group B which was 'No treatment concurrent control', 'not significant' results were obtained. Conclusion: Present research reveals that swarnaprashan works as an immune-modulator which decreased the morbidity rate and therefore can be a simple remedy to bring down the morbidity rate in children.
Keywords: Children morbidity, recurrent diarrhea, recurrent fever, recurrent respiratory infections, Swarnaprashan
|How to cite this article:|
Sinha N, Ojha NK. Study of pattern of morbidity in children under 5 years and effect of Swarnaprashan on morbidity status. J Ayurveda 2021;15:170-80
|How to cite this URL:|
Sinha N, Ojha NK. Study of pattern of morbidity in children under 5 years and effect of Swarnaprashan on morbidity status. J Ayurveda [serial online] 2021 [cited 2022 May 16];15:170-80. Available from: http://www.journayu.in/text.asp?2021/15/3/170/326703
| Introduction|| |
Infant and child mortality and morbidity remain a challenge, especially in the developing world. More than half of the children (53.7%) are suffering from some form of illness. Recurrent respiratory infection, recurrent diarrhea, recurrent fever, etc., are the most common causes of morbidity in immunocompromised children. In India, 15% of death that occurs during infancy and 1–5 years of age is due to respiratory infections. Diarrhea is the most important cause of chronic morbidity followed by malnutrition. Diarrheal disease is the second leading cause of death in children under 5 years of age.
These statistics show that children are more vulnerable to infection as their immune system is not fully developed. Hence, the health status of this vulnerable age group (under-5 children) is very much important as morbidities affect their health which influences on the overall health status of the country. Lehana (means intake of medicine by licking) is one such traditional special formulation, mentioned in Ayurveda classics that have been used to enhance growth and development by providing sufficient nutrition, promotion of health, complexion, and strength (immunity), protecting from various infections along with improving intellect and speech (delayed milestone).
Swarnaprashan is intended to boost memory, intelligence, and immunity in infants. It can be administered in children as an immunomodulatory in early ages as this period until 1 year is considered to be the most vulnerable time for infections, due to immature immune system. Swarnaprashan therapy is becoming widely popular and being administered on the Pushya Nakshatra of every month at Ayurveda centers across India.
The specific benefits ascribed to Swarnaprashan are Medha-Agni-Bala-Vardhanam (improvement of intellect, digestion, metabolism, immunity, and physical strength), Ayushyam (promoting lifespan), Mangalam (auspicious), Punyam (righteous), Vrushyam (aphrodisiac), Varnyam (enhancement of color and complexion), and Grahapaham (protection from evil spirits and microorganisms). If administered for 1 month, the baby will become Parama Medhavi (highly intelligent) and Vyadhibhir Na Cha Ghrishyate (will not be affected by any disease). If administered for 6 months, the baby will become Shrutadhara (will be able to remember the things, which are just heard).
Aim and objectives of the study
The present research study has been planned to conduct with following main objectives.
- To observe the morbidity status in children with Swarnaprashan
- To study the immunomodulatory effect of Swarnaprashan.
Need and significance of the study
Though National Immunization Schedule is implemented, the child mortality rate in India is still high. From the 1st day of life vaccination schedule is started, but these all Vaccines provide specific immunity. These specific vaccines are not able to protect the children from all type of infections and also do not prevent from primary-secondary immunodeficiency syndromes. The vaccine takes almost few months for activation of immune system and production of specific immunoglobulin against that specific antigen. Hence there is the need of the country to make available a non-specific immune enhancing agent which boost up overall the immune system of body, helps to protect children from recurrent infections and it should be palatable to the child. Lehana can be administered in all children as it acts at the level of nutrition, metabolism, growth and development, physical strength, and immunity. Ancient Indians used different Lehana preparations for Swarnaprashan. Gold nanoparticles are capable of encapsulating active drugs and targeting. This proves the Yogavahi (bioavailability enhancing) property of Swarna. With the potential role of Swarnaprashan in boosting nonspecific immunity and overall growth and development, initiative needs to be taken to promote and incorporate Swarnaprashan as a Public Health Initiative by the Government of India. The department of AYUSH should include Swarnaprashan under mother and child healthcare scheme.
| Materials and Methods|| |
- Study type: Randomized controlled trial/conventional treatment
- Masking: Open label
- Control: No treatment concurrent control
- Timing: 4 weeks
- End point: Safety and efficacy
- Number of groups: Two
- Number of subjects to be completed in the clinical trial (sample size): 60.
- Total trial period: 4 weeks
- Follow-up period: Every 7 days and 4 weeks and 12 weeks (posttreatment).
Selection of cases
Children of 6 months to 5 years of age were selected for the study.
Grouping of patients
A total of 60 cases were divided into two groups (30 in each).
- Group A: Trial drug (Swarnaprashan) (30 cases)
- Group B: No treatment concurrent control (30 cases).
In Group B which was no treatment concurrent control, children with presenting complaint were given symptomatic treatment and called for follow-ups every 7 days during the trial therapy and after 4 weeks and 12 weeks after completion of trial. No any immunomodulatory treatment was given in the control group.
- Children aged between 6 months and 5 years of either sex
- Children with recurrent respiratory infections
- Children with recurrent gastrointestinal tract diseases
- Children with recurrent episodes of fever
- Children with other recurrent diseases (otitis media, tonsillitis, urinary tract infection [UTI]).
- Subjects suffering from major systemic illness necessitating long-term treatment
- Subjects with evidence of malignancy
- Subjects with concurrent serious hepatic dysfunction (defined as Aspartate transaminase (AST) and/or ALT >3 times of the upper normal limit) or renal dysfunction (defined as serum creatinine >1.2 mg/dl), uncontrolled pulmonary dysfunction (asthmatic and Chronic obstructive pulmonary disease (COPD) patients)
- Comorbidity such as tuberculosis and bleeding disorders
- History of hypersensitivity to any of the trial drug or their ingredients
- Subjects who have completed participation in any other clinical trial during the past 6 months.
The result of the clinical study was assessed based on the observations of clinical features and laboratory findings. Following parameters were adopted for assessing the patients before, during, and after treatment.
This included various manifestations of poor immune status in children such as recurrent respiratory infections, recurrent gastrointestinal infections, and recurrent skin infections.
Morbidity score was calculated as:
Morbidity score = Incidence from the last 3 months × severity
Laboratory parameters (hematological and biochemical parameters)
Following parameters were adopted for the assessment of the patients under trial: IgG, Hb gm%, total leukocyte count (TLC), neutrophil count, lymphocyte count, eosinophil count, erythrocyte sedimentation rate (ESR).
- Any acute or severe illness
- Parents not willing to continue the treatment.
Trial drug: Swarnaprashan
The trial drug Swarnaprashan was prepared in the form of drops (mixture of Swarnabhasma, Brahmi Ghrita, and Madhu) to enhance its palatability and for easy administration in children [Table 1].
Presentation of trial drug
Trial drug was packed in 10 ml vial and administered in the form of drops.
Dose and duration
Shuddha Swarnabhasma was emulsified with Brahmi Ghrita and Madhu and administered in drop form per kg weight (0.1–0.2 mg/kg/day or 1 drop/kg/day) for 4 weeks (28 days), and follow-up was done weekly and posttreatment follow-up was done after 4 weeks and 8 weeks of trial therapy.
The clinical efficacy of the drug was analyzed statistically on all parameters mentioned in the assessment criteria. Scoring of morbidity features was done before, at follow-ups, after treatment, and 4 and 12 weeks after discontinuation of the drug. Thus, obtained results in each group were statistically analyzed by using “Student's paired test” for the variation and significance of effect seen in individual groups, and “Mann–Whitney test” was used for intergroup differences between all groups. All the parameters adopted, i.e., morbidity features, morbidity score, and laboratory values, were statistically analyzed, and after that, the results of every parameter are discussed.
The study was approved from institutional ethics committee, NIA with No. IEC/ACA/2017/95 on dated April 26, 2017.
The study was registered in CTRI with reference no. REF/2018/04/019548 and registration no. CTRI/2019/04/018759.
| Observation|| |
A total of 69 children with different morbidities were registered in the clinical study, out of which nine subjects discontinued the trial. The study was completed on 60 subjects and the subjects were randomly divided into two groups (30 in each).
It was observed that out of 60 enrolled subjects, maximum 46 (82.14%) subjects suffered from recurrent episodes of running nose, followed by 44 (78.57%) with recurrent cough, 42 (75%) with recurrent nasal obstruction, 36 (64.29%) with recurrent sore throat, 34 (60.71%) with dyspnea, 29 (51.79%) with enlarge tonsils, and 23 (41.07%) with recurrent fever, while minimum 8 (13.33%) subjects suffered from recurrent diarrhea. Group wise distribution of subjects with morbidity features are showed by diagram [Graph 1].
| Results and Discussion|| |
Acharya Chakrapani has elaborated the term Vyadhikshamatva as Vyadhi Bala Virodhitva and Vyadhyutpaada Pratibandhakatva. The Vyadhikshamatva mostly depends on Bala that opposes the disorder state of Doshas. Charaka describes that the maintenance of health depends entirely upon the Bala. This strength is attainable from three sources – Sahaja Bala (constitutional strength), Kalaja Bala (temporal strength), and Yuktikrita Bala (acquired strength). To increase the immunity of children, Ayurveda drugs having Rasayana, Balya, and Ojovardhaka property can be used to increase the Yuktikrita Bala. This concept of Ayurveda is used in the present study to enhance immunity in children.
In the current study, maximum numbers of subjects were in the age group of 4–5 years, i.e., 28% (30% in Group A and 26.67% in Group B). The males (66.67% from Group A and 73.33% from Group B) were found to be more susceptible than females. This may be due to different levels of immunoglobulin. It revealed that serum IgM levels of girls were generally higher and differed significantly from those of the boys. Most of the cases (Group A – 60% and Group B – 67%) enrolled in the study were belonging to nuclear families. Nuclear families have less time to take care of the diet and health condition of their children because in most of the families both parents are working. Maximum numbers of children were Hindus (Group A – 83% and Group B – 80%). Higher incidence of Hindu religion may be due to predominance of Hindu community in the study area. To draw any inference, further extensive study is needed in large population. The study showed that maximum numbers of subjects were from urban region (Group A – 63.33% and Group B – 73.33%). As the study area was situated in the urban region, maximum subjects from urban area justify the present finding. In the present study, maximum numbers of subjects were from middle (Group A – 56.67% and Group B – 66.67%) followed by lower class (Group A – 16.67% and Group B – 23.33%). This type of distribution was found because only middle- and lower-class families approach to government hospitals for cheaper treatment, and they are unaware of the importance of health and nutrition of their child. Socioeconomic status was measured with the help of Kuppuswamy Scale [Table 2].
Majority of cases were delivered as full-term gestation (Group A – 93.33% and Group B – 86.67%). Only 10% of cases were found to be delivered preterm, and no case was found to be delivered postterm. It is known that children who had assisted problem in delivery may develop problems in the future life, especially that related to growth and development. The uninterrupted growth and development are essential for being healthy including that related with immune system. In the present study, any such observation was not found.
Maximum subjects (Group A – 80% and Group B – 86.67%) had given history of breast feeding initiation immediate after birth and rest (Group A – 20% and Group B – 13.33%) after some days of delivery. Data reveal that mothers prefer breast feeding to other milk or may be that maximum birth 90% were full term and there is no problem for mother in production and secretion of breast milk for full-term baby. This is also evidenced that breast milk promotes adequate infant growth and development as it supplies the ideal mix, density, and physiological form of nutrients. It also reduces exposure of infants to enteropathogens by its antibacterial and antiviral properties. Breast milk may also have a similar influence on allergic, autoimmune, inflammatory bowel diseases, and certain tumors. It protects against diarrhea, respiratory tract infections, otitis media, bacteremia, bacterial meningitis, botulism, UTIs, and necrotizing enterocolitis and may improve overall vaccine response. The study also reveals that breast milk contains a wealth of immune factors, which are designed to nourish and protect the vulnerable newborns during the critical postpartum period.,
Out of 60 subjects, maximum (38.33%) subjects had duration of breast feeding for less than 4 months followed by 19 (31.67%) subjects having 4 months, 11 (18.33%) subjects have duration of breast feeding for 6 months, and 7 (11.67%) subjects received top feeding. The American Academy of Pediatrics further recommends exclusive breastfeeding for the first 6 months and breast feeding at least through the 1st year of life. Maternal factors such as stress, anxiety, and smoking can decrease milk production, but the quantitative and caloric value of breast milk does not change with dieting and exercise.,,,,, Majority of subjects (53.33%) were given complementary food during 6–12 months of age. However, in 20% of subjects, it was observed that weaning was done even before 6 months of age, and in 26.67% of subjects, weaning was done after completion of 1 year of age. It is shown that early, as well as late weaning, alters both child's nutritional and morbidity status. In the present study, data do not match with this theory. It revealed that as soon as breast feeding is no longer adequate as the main source of food, complementary feeding becomes imperative to avoid nutritional deficiency, particularly of iron. For children with normal birth weight born to a well-nourished mother, complementary feeding is required by age of 6 months. For children born to poorly nourished mothers, complementary feeding is required sooner, and low-birth-weight babies may need iron supplementation by as early as age 2 months or their susceptibility to infection will be increased.
Maximum cases were vegetarian (Group A – 80% and Group B – 80%). Rest 20% cases were found to have mixed pattern of diet. There is no direct relation of type of diet to recurrent infections or immunity because the quality of diet matters the nutrition of the individual, and if the nutrition is proper, then immune system will also prompt. According to Dashvidha Prikshya Bhava, maximum numbers of subjects were found Vata-Kapha Prakriti (Group A – 73.34% and Group B – 66.67%). There is predominance of Kaphaprakriti in Balyavastha so the chances of getting Kaphasthan (Uraha) GataVyadhi increase. Upper respiratory tract infection (URTI) is more common in children and low immunity may be due to Srotavarodh, Aparipakva Dhatu, leading to Alpa Ojas. In other classical reference, Vataprakriti children have AlpaBala so the chance of getting VatasthanGataVyadhi increase. Overall, it is concomitant that Vata-KaphaPrakriti is more vulnerable for higher morbidity in children. Maximum 53.33% (Group A – 53.33% and Group B – 50%) were found with Mandagni. Agni Dushti (Visham or Manda) is the main cause of Ama production, which is responsible for Vyadhikshamatva Hrasa. Mandagni and Vishmagni lead to improper digestion of food and thereby improper formation of Dhatu and Bala. [Table 2].
36 (60%) and 14 (23.33%) subjects were underweight and overweight followed by 10 (16.67%) subjects being average weight per age. Gain in body weight and height indicates normal progressive health status of an organism. Decrease in body weight is indicative of degenerative changes in the body or certain organs. This study also documented that Swarnaprashan was proven effective in gaining weight. Swarnaprashan maintained general health by increasing immunity level of the body. It also improves digestion and metabolism of the body which keeps the Tridoshas in balance state. Thus, the child is free from seasonal variances and shows effective growth in their physical parameters.
Majority of subjects, i.e., 85%, were completely immunized as per schedule. No and partial immunization were found in 0% and 15%, subjects, respectively. The reasons of no and partial immunization are unawareness, less advertising, and some myth regarding vaccination in low socioeconomic population. Statistics shows that the morbidity rate increases due to lack of immunization or partial immunization compared to fully immunization [Table 2].
Maximum 46 (76.67%) subjects were suffered from recurrent episodes of running nose, followed by 44 (73.33%) with recurrent cough, 42 (70%) with recurrent nasal obstruction, 36 (60%) with recurrent sore throat, 34 (56.67%) with dyspnea, 29 (48.33%) with enlarge tonsils, and 23 (38.33%) with recurrent fever, while minimum 8 (13.33%) were suffered from recurrent diarrhea [Table 2]. According to data from annual health surveys (AHS) 2012-13 and census of India 2011, Rajasthan have 55 infant mortality rate, 74 under-five mortality rate, 37 neonatal mortality rate, 18 postnatal mortality rate, 13.4 % of children suffering from diarrhea, 15.9 % of children suffering from Acute Respiratory infection and 20.3% children suffering from fever.
In group A where trial drug (Swarnaprashan) was given, improvement in some morbidity features were found extremely significant i.e. in running nose frequency, running nose consistency, nasal obstruction, dyspnoea and cough. In fever character, fever frequency, sore throat and diarrhea consistency, statistically very significant improvement was found. In enlarged tonsil and diarrhea frequency only significant relief was observed. In group B, statistically not significant results were observed in all morbidity symptoms [Table 3]. Percentage of overall improvement after treatment in various morbidity features of both group is shown by diagram [Graph 2]. In laboratory parameters, there was statistically extremely significant improvement in Hb%, eosinophil count, and ESR, statistically very significant reduction in TLC, significant reduction in neutrophil and lymphocyte count and increase in serum IgG level. These findings suggest the effectiveness of the drug [Table 4]. In group B which was no treatment concurrent control, 'statistically not significant' results in Hb%, eosinophil count, ESR, TLC, neutrophil and lymphocyte count and serum IgG level was obtained [Table 5]. Intergroup comparison revealed extremely significant gain in running nose (frequency and consistency) and cough (frequency and character), very significant gain in nasal obstruction, enlarged tonsils and fever character and significant advantage in dyspnea, fever character, sore throat and diarrhea in group A over group B [Table 6].
Post treatment follow-up showed sustained effect of the trial drug [Table 7].
|Table 7: Statistical presentation of all morbidity features after treatment and after follow-up (12 weeks) (posttreatment follow-up)|
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A pharmaco-clinical study Madhu-Ghrita-Swarna-Vacha combination on neonates also showed a significant effect of humoral immunity which was evident by triggering the response of immunological system by a rise in the total proteins and serum IgG levels. The Swarnaprashan contains gold as the main ingredient. It is made into Swarnabhasma through a special process because gold cannot be consumed in its metallic form. Gold is known to boost immunity as well as enhance memory. Pharmacological reviews of Swarnabhasma reveal that it possess immunomodulatory, and nootropic properties. Swarnabhasma is used as a chief ingredient in Swarnaprashan for neonates and children. It acts by free radical scavenging effect. Swarnabhasma inhibits the numerous cell-mediated immune response to various mitogen and antigen. Gold compound has immunomodulatory function. It enhances the memory; hence, when it is administered in very low dose for a particular time, it is known to potentiate the memory power along with immunity. Animal researches conducted on pure ash of gold showed the use of Swarnabhasma in dose of 12.5–50 mg/kg of body weight on mice had a stimulatory effect on peritoneal macrophages that might be helpful to fight against infection. It is believed that macrophages achieved stimulation due to presentation of the metal to cells in fine emulsified forms. Conventional gold preparations are credited with rejuvenating and antioxidant properties. Swarnabhasma, the principal ingredient of Swarnaprashan, enhances immunity through phagocytosis and is found to be effective in motor neuron diseases in small dose. Swarnabhasma have been incorporated both in Ayurveda and medical science for rejuvenation and immunomodulation in many chronic diseases.
Morbidity features such as running nose, nasal obstruction, sore throat, enlarged tonsil, dyspnea, and cough are considered as Urdhajatrugatavikara in Ayurveda. Dosha responsible in occurrence of Urdhajatrugatavikara is vitiated Vata and Kapha. Swarna and shankhapushpi have TridoshaShamaka, properties and Brahmi and Vacha, have kapha-vatashamaka, properties. So wit
h the help of these properties, the trial drug clears the channels. Swarna, Vacha, Brahmi, and Kushtha have anti-inflammatory properties. Swarna has antiasthmatic properties, and honey has property of reducing frequency of cough. Hence, all the morbidity features related to Urdhajatrugata improved by these properties of drugs.
Cough in URTI is mainly due to postnasal dripping and infection in throat and respiratory tract. Anti-inflammatory,, and antibacterial activity,,, of ingredients such as Swarna, Vacha, Kushtha, Shankhapushpi, Brahmi, and Madhu are responsible for relief in cough.
Maximum ingredients of trial drug such as Swarna, Vacha, Brahmi, and Kushtha, were having immunomodulatory activity by means of which trial drug showed significant role in improvement in URTI symptoms. Immunomodulatory effect reduces the morbidities by means of immune enhancing effect and provides long-term sustained effect.
Ingredient such as Vacha having antipyretic activity showed improvement in fever. Efficacy of trial drug in reducing the diarrheal episode is because of antidiarrheal activity,, of ingredients such as Vacha, Brahmi, and Kushtha.
Brahmi, Vacha, Kushtha, Shankhapushpi, and Madhu showed antibacterial or antimicrobial activities.,,,, By virtue of these properties of contents of trial drug, the morbidity features like enlarged tonsil, sore throat, URTI, fever and diarrhea were improved.
| Conclusion|| |
Present research reveals that Swarnaprashan works as an immunomodulator which decreased the morbidity rate in both frequency and severity and therefore can be a simple remedy to bring down the morbidity rate in children. No adverse effects of the trial drug were observed during the study. In Group A where trial drug (Swarnaprashan) was given, statistically extremely significant and very significant improvement in most of the morbidity features were found. However, in Group B, which was no treatment concurrent control, statistically not significant results were obtained. The trial drug (Swarnaprashan), increased Hb%, decreased eosinophil, decreased ESR level in children at a statistical extremely significant, decreased TLC in children at a statistical very significant, decreased neutrophil, decreased lymphocyte, and increased IgG in children at a statistical significant level, suggesting the effectiveness of the drug. Intergroup comparison showed that extremely significant advantage in running nose and cough followed by very significant gain in nasal obstruction, enlarged tonsil, and fever frequency and significant gain were found in dyspnea, fever character, sore throat, and diarrhea in Group A over Group B. Posttreatment follow-up showed sustained effect of the trial drug.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]