|Year : 2021 | Volume
| Issue : 1 | Page : 34-41
Immunological, biochemical, and infant-toddler quality of life parameter-based study of Swarna Prashana (a herbo-mineral ayurveda preparation) in infants
Satyawati Rathia1, Lowkesh Chandravanshi1, Virendra Kumar Kori2, Kalpana Patel2, Prashant Kumar Gupta1
1 Department of Kaumarbhritya, Shri NPA Government Ayurveda College, Raipur, Chhattisgarh, India
2 Department of Kaumarbhritya, IPGT and RA, Jamnagar, Gujarat, India
|Date of Submission||15-Jul-2020|
|Date of Acceptance||23-Feb-2021|
|Date of Web Publication||27-Apr-2021|
Dr. Satyawati Rathia
Department of Kaumarbhritya, Shri NPA Government Ayurveda College, Raipur, Chhattisgarh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Increasing rate of emergence of newer infection, resistance to antibiotics, reoccurrence of infections, and malnutrition have created a space for an effective and safe solution of above issues to mankind. Swana Prashana is a unique concept of Indian system of medicine for improving the generalized immunity consequently helping the child to resist and fight against various infection and diseases. Aims: Study was planned to evaluate the efficacy of Swarna Prashana and Swarna Vacha Prashana in infants. Materials and Methods: A randomized, controlled, single-blind clinical study was planned in healthy infants to study the effect of Swarna Prashana in anthropometry, hematological, biochemical, immunological, and infant-toddler quality of life (ITQOL) parameters in 3 differently categorized groups namely Group A: (n = 39, Ghrita and Madhu). Group B: (n = 42, Swarna Bhasma, Ghrita and Madhu) Group C: (n = 38, Swarna Bhasma, Ghrita, Madhu and Vacha Churna). Results: The present clinical study showed statistically highly significant (P < 0.001) increase in all the anthropometrical measurements of infants all three groups. The drugs did not hamper normal growth of the infants and they did not have any additional effect on enhancing the anthropometrical values. Hematological and biological parameters did not show significant difference in comparison in all groups. The results of Renal function and liver function tests were in normal limits after completion of treatment and post treatment follow-up suggestive of safe to be administered in infants. Immunological parameters also did not show significant difference of comparison in all groups except in Group C where immunoglobulin G (IgG), IgM, albumin, globulin levels were increased. Group C significantly improved all the ITQOL parameters while on comparison significant difference was observed in improving the physical abilities only. Conclusion: Current study suggests Swarna Prashana as infants health promotive and morbidity preventive. Author advocates a large scale randomized double blind clinical trial for further validation of impact of Swarna Prashan as mass health-care initiative.
Keywords: Ayurveda, immunomodulation, Swarnaprashan, Vyadhi kshamatva
|How to cite this article:|
Rathia S, Chandravanshi L, Kori VK, Patel K, Gupta PK. Immunological, biochemical, and infant-toddler quality of life parameter-based study of Swarna Prashana (a herbo-mineral ayurveda preparation) in infants. Phcog Res 2021;13:34-41
|How to cite this URL:|
Rathia S, Chandravanshi L, Kori VK, Patel K, Gupta PK. Immunological, biochemical, and infant-toddler quality of life parameter-based study of Swarna Prashana (a herbo-mineral ayurveda preparation) in infants. Phcog Res [serial online] 2021 [cited 2021 May 14];13:34-41. Available from: http://www.phcogres.com/text.asp?2021/13/1/34/314804
- Swarna Prashana is safe and effective in maintenance of health of infants. It can potentially contribute to malnutrition management through public health initiative in India.
Abbreviations Used: ITQOL - Infant-toddler Quality of Life: IgG - Immunoglobulin G; IgM - Immunoglobulin M; SGPT: Serum Glutamic Pyruvic Transaminase; SGOT: Serum Glutamic Oxaloacetic Transaminase; Hb: Hemoglobin; TLC: Total Leukocyte Count; TRBC: Total Red Blood Cell count; PLT count: Platelet Count; AIDS: Acquired Immune Deficiency Syndrome.
| Introduction|| |
Swarna Prashana is a combination of two words – “Swarna” and “Prashana”. Swarna refers to the noble metal Gold (Au). Prashana is act of eating/consuming/ingesting. Swarna Prashana refers to the act of consuming or ingesting gold in the prescribed dose and quantity in the suggested manner, sometimes referred as Swarna Bindu Prashana. Swarna Prashana is a cultural practice in India and has included in JatakarmaSamskara which is one of the 16 essential Samskars described in Indian tradition. Raw gold is rubbed on a stone with water while facing towards east chanting holy Mantras and is administered with honey and ghrita to a newborn just after birth (Jaatmatra). With the time, raw gold has replaced by Swarna Bhasma while some drugs like Vacha Churna (Acorus calamus) and Brahmi (Bacopa monnieri) are now added as ingredient of Swarna Prashana. The word Prashana is also having a synonym as Lehana and Lehya (lickable) indicates unctuous, sticky and semisolid variety of food/medicinal preparation. Oral administration by Lehana is considered to be convenient and safe way in pediatric age group. It enhances Medha (Intelligence), Agni (digestive power), Bala (strength), and Ayu (age). It is Varnya (complexion), Pavitra (pious), and Mangalkaraka (good will). Therapeutically used in Grahabadha and is Vrishya. If it is administered daily for a month, the child will become Medhavi (intelligent). If its administration continued for 6 months, the child will become Smritivan (increase memory), and Shrutadhara (remember everything which is heard).
In Kashyapa Samhita, while describing the benefits of Swarna Lehana, Acharya Kashyapa opines that, by feeding the gold for 1 month, the child is not attacked by any disease. This classical description implicates that ingestion of Swarna modulates immune mechanism, so that morbidity is reduced. Swarna Bhasma has immunomodulatory,, free radical scavenging, analgesic, and anti-stress effect. In vitro, in vivo and Clinical Studies done on Swarna Prashan/Swarna Bindu Prashan have suggested that it has a good immunomodulation, growth promoter,,, antitussive and may support quality of life in cancer patients during anti-cancer treatment.
Randomized clinical trial study is the essence of any research work. It reveals the promises and pitfalls of any hypothesis and improves its practical applicability. The concept of Swarna Prashan is an experience based-documented practice of disease prevention in the field of childcare since many decades. At this juncture, it becomes an essential to revalidate the hypothesis and observations according to the norms and practices of the present day clinical research. Hence, a systematic clinical study was planned to evaluate the immunomodulatory and growth promoting efficacy of Swarna Prashana given in healthy pediatric age group subjects.
| Materials and Methods|| |
A written informed consent was obtained from the parents of infants (attained weight > 2.5 kg) approached before participation in the study from Out Patient Department and In Patient Department of Kaumarbhritya, IPGT and RA Jamnagar. Vaccination schedule was not interrupted during the study. The study protocol was approved from the ethical committee of IPGT and RA Jamnagar, India wide letter No. PGT/7-A/Ethics/2011-2012/2796 and the Research work has been registered in Clinical Trial Registry of India (CTRI)-CTRI/2012/03/002505 dated March 20, 2012.
- Full term newborn and healthy infants (age between 0 and 12 months) of either sex
- Birth weight >2.5 kg (newborn).
- Children more than 12 months
- Congenital anomalies and hereditary diseases
- Sick infants with infectious diseases, metabolic disorders.
This study is stage II clinical trial, in which the experimental study drug (Swarna Prashana) is given to a larger group (>100) to see the effective and safety purpose. A randomized, controlled, single-blind clinical study was planned and randomized sampling was followed to divide the patients in three different groups. Random sampling (Computer generated Random number table) was followed.
- Group A-Madhu–Ghrita (Unequal-quantity)
- Group B– Swarna-Madhu–Ghrita (Unequal quantity)
- Group C– Swarna-Vacha-Madhu-Ghrita (Unequal quantity)
Complete physical examination and detailed evaluation of the infants with respect to growth and development were done and documented the findings in a specially prepared proforma namely anthropometric changes such as length, head circumference, chest circumference, developmental milestones, gross motor, fine motor. The assessment of total effect of therapy was considered by the improvement in infant-toddler quality of life parameters (ITQOL). Routine investigation (hematological parameters) for monitoring changes were Hb gm%, total red blood cell count, total leucocyte count, differential leukocyte count, erythrocyte sedimentation rate, platelet counts, renal function test, liver function test, total serum protein, and serum immunoglobulin G (IgG) and IgM levels were carried out at the time of registration and subsequent follow ups.
Two milliliters blood of each patient was collected through the sterile syringe from a peripheral vein at first visit and on the subsequent follow-ups. All the samples were collected in between 10 and 12 AM to reduce diurnal variation.
Selection of drug
The selection of Swarna Bhasma was based on the textual indication. The drug Swarna Bhasma was provided by Rasshastra and Bhaishjya Kalpana Department, IPGT and RA, Jamnagar. The drug was prepared according to method as described in Ayurvedic formulary of India; 1976.
Madhu (Honey) and Grita
Honey and Grita for the purpose of clinical study was taken from Khadi Gramoudhyog, Supermarket, Jamnagar. Ghrita was manufactured by Schreiber Dynamix Dairies Ltd., Maharastra and Honey was processed and marketed by Azad Kutir Udhyoga Sansthan, Uttar Pradesh. Patient's attendants were advised neither fridge nor to heat it.
Vacha was procured from Ayurvedic pharmacy, IPGT and RA, Jamnagar.
As both ghee and honey were adjuvant drugs, only dosage of Swarna Bhasma was fixed according to the age of infants in months by following Fried's Rule. Swarna Prashna drops were administered orally once day in the morning for 4 weeks. Details of doses of Vacha and Gold according to age are shown in [Table 1].
There were three follow-up to every registered patient-first on completion of 4th week and second and third post treatment follow-up on 8th week (post-treatment 4th week) second on 12th week (post treatment 8th week). The clinical and anthropometric parameter response of the treatment of each case was observed and recorded on follow-up on a prior designed pro forma for the study.
t-test and one way ANOVA followed by Dunn's Method.
| Results and Discussion|| |
A randomized, controlled, single-blind clinical study was conducted to assess and compare the efficacy of (Swarna PrashanaYoga) with and without Vacha and combination of Madhu and Ghrita in infants aged 0–12 months.
In the present study, a total of 119 children were registered based on inclusion criteria; 39 in Group A, 42 in Group B and 38 in Group C, details of enrolled, completed and dropout subject are given in [Table 2].
Total of 119 children were registered based on inclusion criteria; 39 in group A, 42 in group B and 38 in Group C, out of which 31in Group A, 34 in group B and 32in group C completed the treatment whereas 8 children in Group A, 8 in Group B, and 6 in Group C discontinued the treatment shown in [Chart 1].
One hundred and eighteen (99.15%) mothers had underwent regular antenatal checkup and only 1 (0.85%) had irregular checkup while 117 (98.31%) of the mothers were vaccinated during pregnancy and 2 (1.68%) mothers were not vaccinated during pregnancy.
Total 4 (3.361%) subjects were preterm, 112 (94.11%) were term while 3 (2.52%) subjects were postterm. One hundred and nine (91.59%) subjects were cried soon after birth and 10 (8.41%) were did not cry soon after birth and only 1 (0.85%) subject had a history of neonatal intensive care unit admission. Exclusively breast fed were given to 39 (100%) Group A, 41 (97.62%) Group B and 36 (94.74%) in Group C. Total 16 (8.84%) subjects were suffered from illness in past time.
All the three groups showed statistically highly significant (P < 0.001) increase in all the anthropometrical measurements of infants aged 0–1 month and 1–12 months. On comparison there was no statistically significant difference between all the groups. Drugs did not hamper normal growth of the infants, while maintaining the health of the infants. Details parameters of anthropometry and their means, standard deviation, intergroup comparison, and statistical significance are shown in [Table 3] and [Table 4].
Group A showed statistically significant (P < 0.001) decrease in hemoglobin and significantly (P < 0.05) increase in lymphocyte counts. Group B showed statistically significant (P < 0.05) decrease in hemoglobin, neutrophil count, and increase platelets and lymphocyte counts. Group C showed statistically highly significant (P < 0.001) decrease in hemoglobin, neutrophil, statistically significant (P < 0.05) decrease in Total Red Blood Cell Count (TRBC), and statistically highly significant (P < 0.001) increase in lymphocyte counts. Hemoglobin, neutrophil, and TRBC decrease according to age of infants while lymphocytes increase respectively. All the above-mentioned changes were within normal limits showing that drugs did not interfere to the normal physiology of hematological parameters [Table 5].
On comparison all three groups, drug did not show statistically significant difference on hematological parameters of infants aged 1–12 months. Detailed hematological parameters and their means, standard deviation, intergroup comparison, and statistical significance are shown in [Table 6].
Group A and Group B did not show any statistically significant difference on Biochemical parameters. Group C showed statistically significant (P < 0.05) decrease in Sr. Creatinine. The decreased Sr. Creatinine value was within the normal limits and so it might have occurred by chance. Some of these normal ranges change markedly when age drops below 2 years and especially below 1 year [Table 7]. On comparison all three groups, drug did not show any statistically significant difference on biochemical parameters of infants aged 1–12 months. Detailed biochemical parameters and their means, standard deviation, intergroup comparison, and statistical significance are shown in [Table 8].
All three groups did not show any statistically significant difference on Immunological parameters. IgG volume marked increase after t/t in Group B and marked increases IgG, IgM, Globulin volume in Group C, but it was not statistically significant. These values should be decreased up to 1yr. Increased IgG mean a long-term (chronic) infection, such as AIDS, multiple myeloma, long-term hepatitis, and multiple sclerosis. Detailed immunological parameter and their means, standard deviation, intergroup comparison and statistical significance are shown in [Table 9] and [Table 10].
Infant-toddler quality of life parameters
Group A showed statistically highly significant (P < 0.001) improvement on physical abilities, temperament and mood, general health, parent impact and statistically significant (P < 0.05) improvement on growth and development.
Group B showed statistically highly significant (P < 0.001) improvement on physical abilities, temperament and mood, general health, parent impact (Time), and statistically significant (P < 0.05) improvement on Growth and development and bodily pain/discomfort. Group C showed statistically highly significant (P < 0.001) improvement on bodily pain/discomfort, temperament and mood, general health, parent impact (Time) and statistically significant (P < 0.05) improvement on physical abilities, growth and development and parent impact (emotional), thus significant effect on all ITQOL parameters [Table 11].
On comparison all three groups, statistically highly significant (P < 0.001) improvement by bodily pain/discomfort, and statistically significant (P < 0.05) effect by general health and parent impact (Time), but did show statistically significant difference on rest of the parameters. ITQOL is an important subjective parameter, where improvement can be observed both by mothers and noted by the physicians. This shows that the drugs did not hamper the quality of life of Infants, of course increased it. Detailed ITQOL parameters and their means, standard deviation, intergroup comparison, and statistical significance are shown in [Table 12].
|Table 12: Comparison of effect on Infant-Toddler Quality of life parameters|
Click here to view
| Conclusion|| |
The present clinical study showed statistically highly significant (P < 0.001) increase in all the anthropometrical measurements of infants all three groups. The drugs did not hamper normal growth of the infants and they did not have any additional effect on enhancing the anthropometrical values. Hematological and biological parameters did not show significant difference in comparison in all groups, but were in normal limits. The results of Renal function and liver function tests were in normal limits even after completion of treatment which suggests that the drug was safe to be administered in infants. Immunological parameters also did not show significant difference of comparison in all groups except in Group C IgG, IgM, Albumin, Globulin levels were increased.
Group C significantly improved all the ITQOL parameters. But on comparison, it showed significant difference, only in improving the physical abilities. On the rest of the parameters there was no difference between three groups. Hence it could be concluded that Swarna Prashana can be safely administered for infant for a supportive care for attaining a normal growth and development. Author advocates a large scale randomized double blind clinical trial for further validation of impact of Swarna Prashan as mass health-care initiative.
We would like to acknowledge Prof. P K Prajapati, Department of Rasashastra and Bhaishajaya Kalpana, IPGT and RA, Jamnagar, India, for his support in drug development and expert opinion.
Financial support and sponsorship
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], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12]