|Year : 2021 | Volume
| Issue : 2 | Page : 114-119
Effectiveness of Saptamrita Loha on Panduroga (iron deficiency anemia) in children an open-label prospective clinical trial
Virupaxayya Hiremath1, Reena Kulkarni2
1 Department of Kaumarabhritya, Ashwini Ayurveda Medical College and Hospital, Davanagere, Karnataka, India
2 Department of Kaumarabhritya, SDM Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu Post, Bangalore, Karnataka, India
|Date of Submission||13-Nov-2020|
|Date of Decision||18-Mar-2021|
|Date of Acceptance||08-May-2021|
|Date of Web Publication||28-Jun-2021|
Dr. Reena Kulkarni
Department of Kaumarabhritya, SDM Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu Post, Bangalore 560074, Karnataka.
Source of Support: None, Conflict of Interest: None
Introduction: Panduroga is a systemic disorder that presents with pallor; it is correlated to anemia. Iron deficiency is the most common nutritional deficiency on the globe that contributes to the highest incidences of anemia. Oral iron therapy is the treatment in iron deficiency anemia (IDA), which is associated with adverse reactions such as gastrointestinal irritations on long-term usage. Saptamritaloha is a frequently prescribed herbo-mineral drug from Ayurveda pharmacopeia in the context of eye disorders and it is also used to treat Panduroga. Hence, Saptamritaloha was subjected to a safety and efficacy trial. The aim of the trial was to evaluate the effectiveness of Saptamritalohavati in children with Panduroga (IDA). Materials and Methods: An open-label, controlled, prospective clinical trial in children aged 12–16 years was conducted over a period of two months. Assessment was done based on changes in clinical features and complete blood count analysis before and after therapy. The changes were assessed using paired and unpaired t test, Friedman test, and Wilcoxon sign-rank test. Results: A total of 43 children (22 in the study group and 21 in the control group) were registered in the trial, out of whom 20 in each trial and the control group completed the study. The present study shows that Saptamritaloha is effective in improving the clinical features and hematological parameters significantly and the results were comparable with the standard control used, namely Dhatriloha. The mean improvement in hemoglobin (Hb) was 1.17 g% in the trial group during the course of treatment (P < 0.001). No adverse drug reactions were noted in the study. Discussion: Saptamritaloha vati increases Hb and red blood corpuscles (RBC), packed cell volume (PCV), and mean corpuscular hemoglobin concentration (MCHC) by virtue of its ingredients. The herbal ingredients in the formulation, namely Triphala (group of three drugs, namely Haritaki [Terminalia chebula Retz.], Bibitaka [Terminalia bellirica (Gaertn.)Roxb], Amalaki [Phyllanthus emblica L], Yashtimadhu [Glycyrrhiza glabra L], Madhu [Honey], and Ghrita [Ghee]), possess Tridoshashamana, Anulomana, and Rasayana property, which aids in better bioavailability, drug absorption and also minimizes the gut irritation after oral iron usage. Conclusion: Saptamritaloha is effective in the management of Panduroga in children.
Keywords: Ayurveda, children, complete blood count, hemoglobin, iron deficiency anemia, Panduroga
|How to cite this article:|
Hiremath V, Kulkarni R. Effectiveness of Saptamrita Loha on Panduroga (iron deficiency anemia) in children an open-label prospective clinical trial. J Indian Sys Medicine 2021;9:114-9
|How to cite this URL:|
Hiremath V, Kulkarni R. Effectiveness of Saptamrita Loha on Panduroga (iron deficiency anemia) in children an open-label prospective clinical trial. J Indian Sys Medicine [serial online] 2021 [cited 2022 Jan 23];9:114-9. Available from: https://www.joinsysmed.com/text.asp?2021/9/2/114/319458
| Introduction|| |
Panduroga presents with clinical pallor, which serves as a diagnostic sign. The specific sites where pallor manifests include the eye, nail, and face. It has been described with various symptom complexes in the classical texts of Ayurveda. It is correlated to anemia of modern medicine. Anemia is a global health concern that affects both developing and developed countries, with iron deficiency being the major contributor. The IDA is one among this spectrum, with its etiology being mostly nutritional deficiency related. Anemia is a major public health problem in India. As per the 2005–2006 National Family Health Survey (NFHS-3), a household survey aimed at having national and state representative data on population health and nutrition; the prevalence of anemia was 70% in children aged 6–59 months, 55% in females aged 15–49 years, and 24% in males aged 15–49 years. Although the prevalence of anemia was higher in rural areas, there may be a paucity of data on its epidemiology in rural settings. Iron deficiency is a preventable cause. A lot of efforts are undertaken by the government of India to prevent and treat the IDA, especially in women and children, through oral iron therapy and food fortification. Due to confounding factors, the efforts are not really converted into health indices. Further, there are several reports on drug intolerance to oral iron therapy.
There are several studies on Ayurveda medicines, such as Dhatriloha,Punarnavamandura,Navayasaloha,Vidangaloha, and Trayatrikadiloha, on anemia in adults. In most of the studies cited earlier, Dhatriloha is used as the standard control drug. There is a paucity of published data on the management of Panduroga in children with Ayurveda medicine. Among the published articles on anemia referred to, two, namely Trayatrikadiloha suspension and Dhatriloha, dealt with children. Further, the research drug selected, Saptamritaloha is another herbo-mineral preparation of Ayurveda that is commonly used to treat Pandu and refractive errors. Saptamritaloha is described in the context of Shula (abdominal pain), as explained in Bhaisajya ratnavali. The most common coexisting clinical conditions in children along with pallor are abdominal pain and vision disturbances. The prevalence of pediatric functional abdominal pain is 13.5%.
Considering these facts, this study aims at validating the oral administration of Saptamrita Loha, a well-known time tested herbo-mineral preparation of Ayurveda containing iron oxide on IDA in children.
| Materials and Methods|| |
An open-label, nonrandomized controlled, prospective clinical trial was conducted in children suffering from features of Panduroga (IDA).
The study was carried out in Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital (SDMCA and H), Hassan, Karnataka, South India.
Children of either sex aged between 12 and 16 years with an Hb level ranging from 8 to 11g/dL were included in the study.
Children with severe anemia (Hb less than 8g/dL), those with concurrent serious hepatic dysfunction and renal dysfunction and uncontrolled pulmonary dysfunction, and those with sensitivity to oral iron therapy were excluded. Children with any other type of anemia except IDA were also excluded from the study.
The decrease of Hb level to less than 8 g/dl during the course of treatment, acute illnesses warranting stoppage of oral iron therapy served as withdrawal criteria. Children with adverse drug reactions, and those not willing to continue the treatment were allowed to withdraw from the trial.
Duration of study: 60 days
The trial was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki for biomedical research and ICMR ethical guidelines human participants (2006), that are consistent with Indian/ICH Good Clinical Practice (GCP) guidelines.
Ethical clearance was obtained from the institutional ethics committee (IEC), SDM College of Ayurveda and Hospital, Hassan, Karnataka (IEC No. SDMCAH/IEC/71/13–14). Informed consent was obtained from head of the school, children and their parents.
Contents of the study drug Saptamrita Loha are summarized in [Table 1].
Method of Preparation
An equal quantity of powders of the earlier mentioned ingredient, except honey and ghee, were taken in a porcelain mortar and pestle; mixed thoroughly; and triturated with honey and ghee to obtain a fine consistency. The paste was put into a tablet cutting machine to obtain a uniform-sized drug heap, which was later rolled into pills of weight 500 mg after drying as recorded on a digital weighing scale.
Dhatriloha was prepared as per reference in Bhaishajya Ratnavali, Shula Roga Chikitsa verse 149-150 at SDM pharmacy, Kuthpady, Udupi was used as control medicine at a dose of 500 mg twice daily after food for a period of 60 days. The ingredients of Dhatriloha are Dhatri (Emblica officinalis Gaertn), Lohabhasma (Ferrosoferric oxide), Yashtimadhu (Glycyrrhiza glabra Linn.), and Guduchi (Tinospora cordifolia [Wild miers]).
Analytical Study of the Trial Drug
Analytical standardization of the trial drug was performed as per AYUSH testing protocol for Vati (Analysis report 591/15032301 dated March 23, 2015), and the results are summarized in [Table 2].
Microbial contamination tests, heavy metal residues, and pesticide residues were within the normal limits.
Technique of Data Collection
Overall, 250 children attending the outpatient department of Kaumarabhritya and also the school children health checkup camps, at SDM College of Ayurveda, Hassan presenting with pallor were screened; those fulfilling the inclusion criteria were recruited for the study. The data on baseline information, history, general physical examination, and systemic examination were obtained by the researcher through direct interrogation and clinical examination. Details of Hb and complete blood count were obtained by laboratory tests. The sample size was decided based on the community prevalence of IDA in school children, in general 37.7%, and in Hassan district, 22.59%, using the formula 4 pq/d2, where p = community prevalence, q = 1 − p, and d = degree of freedom. The data obtained were recorded in the structured clinical proforma.
Schedule of Treatment
The children fulfilling the diagnostic and inclusion criteria were registered and alternatively allocated into study and control groups. The children in both the groups were administered with a single dose of standard deworming drug (Albendazole 400 mg) before initiating the trial medication. Children in the interventional group were administered with Saptamritalohavati (500 mg) after food with water twice daily for a period of 60 days. Children in the control group received Dhatrilohavati (500 mg) in a similar way. The children were reviewed on the 15th day, 30th day, and 45th day, 60th day during treatment, and on the 90th day after follow-up. During the course of treatment, they were advised a normal diet.
Clinical assessment was done before, at an interval of 15 days during treatment, after the completion of the trial (60th day), and after 30 days of the follow-up period (90th day).
The laboratory investigations for complete blood count were done at the start and end of the clinical trial at the laboratory of the SDM College of Ayurveda, Hassan.
The total effect of therapy was assessed in terms of marked response, moderate response, mild response, and unchanged response.
Adverse Effect Evaluation
Adverse effect evaluation criteria: Evaluation and reporting of adverse effect was done as per the guidelines of the national pharmaco-vigilance program for Ayurveda, Siddha, and Unani (ASU) drugs at every two weeks of follow-up.
Analysis of Data
Statistical evaluation was done using software SPSS version 16 by comparing means and standard deviation. Subjective parameters were assessed using Friedman test. Periodic assessment was done using Wilcoxon sign-rank test. Paired t test was used to assess objective parameters of hematology.
| Results and Observations|| |
A controlled clinical trial was conducted to evaluate the effectiveness of Saptamritaloha on Panduroga (IDA), with Dhatriloha as a standard control. The physicochemical characteristics of Saptamritaloha are summarized in [Table 2].
A total of 43 children (22 in the study group and 21 in the control group) were registered in the trial. Three children dropped out during the initial phase of the trial (two in the study group and one in the control group). The remaining 20 subjects in each group were analyzed at the end of the trial. There was equal distribution seen with regards to gender. Among them, 29 (72.5%) belonged to the 12–14 year group and 11 (27.5%) were aged 15–16 years. The majority of them were Hindu (90%), followed by Muslim (1.5%) and Jain (0.5%). Five children were of upper socioeconomic status, 14 upper middle, seven lower middle, one upper lower, and 13 children were of lower socioeconomic status based on Kuppuswamy scale for socioeconomic status. Overall, 24 of the subjects were from urban areas and 16 were from rural areas. Sixteen children were vegetarians, whereas 24 had a mixed diet. In six children (15%), the incidence of PICA was noted. On Prakriti analysis, the majority 20 (50%) were Vatapittajaprakriti as compared with Vatakaphaja (28%) and Pittakaphaja (22%). Incidence of general weakness and pallor was found in 100% of the cases; however, leg cramps (97.5%), exertional dyspnea (94%), loss of appetite (92.5%), lack of concentration (82.5%), dislike for food (50%), hair loss (32.5%), head ache (25%), and palpitations (10%) were seen in the other cases. The clinical features were assessed using Friedman test (Bonferroni correction = 0.0083) for end point analysis. Wilcoxon sign-rank test was done to assess the periodic change on every visit. On analysis, both the groups showed significant improvement in majority of the features of Pandu. The onset of changes in both the groups was observed at around 30 days after the initiation of the therapy (on Wilcoxon sign-rank test), and the improvements were sustained throughout the course of the trial and follow-up. There was significant improvement in the body weight after therapy. The results were statistically significant for parameters such as Hb%, PCV, mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and MCHC concentrations on a complete blood picture. The changes were not statistically significant with regards to palpitations, head ache, irritability, and hair loss. The results are summarized in [Table 3][Table 4][Table 5].
|Table 5: Comparative efficacy of Saptamritaloha on Dhatriloha on body weight and complete blood count|
Click here to view
| Discussion|| |
Anemia is invariably a public health problem all over the world and no age is barred from suffering from it, more so in third-world countries. India is the largest contributor for anemia, especially with regards to women and children. Adolescence, being one among the critical periods of development, gives room to anemia, especially in girls who also attain menarche during this stage of life. More so, anemia is a result of nutritional deficiency in children from middle- and low-income families, who cannot afford quality food. Loss of appetite and worm infestations also worsen the scenario. Children with Pitta dominant Prakriti followed by Vata had more incidence of Pandu. This may be because Pandu is a Pitta Vikara and undernutrition is mostly Vatika, secondary to erratic digestive capacity. Thus, in this study also, Pandu is more prevalent in Pitta Vata dominant Prakriti. Incidentally, Mandagni (anorexia) was associated with the majority of children with pandu. Significant changes in the clinical features of Pandu were noted in children in both the groups at around four weeks of initiation with the drug therapy (P < 0.001), indicating similarity in both trial and control drug. Comparable results were obtained in both the groups with regards to Hb (mean difference: −0.2250), MCV (mean difference: 0.035), and MCH (mean difference: 0.0900). Significant changes were noticed in RBC volume (mean difference: −0.2250, P < 0.035), PCV (mean difference: 0.31500, P < 0.005), and MCHC (mean difference: 0.17000, P < 0.018), indicating better potential of Saptamritaloha in increasing blood parameters. This could further be because of the additional effects of ingredients such as HareetakiMadhu and Ghrita in the study drug that aid better tissue absorption and improve blood parameters. Amalaki, Yashtimadhu, and Guduchi stimulate better tissue absorption, RBC production and improve immunity by virtue of their Rasayana (rejuvenating), Vayasthapana (longevity promoting), and Raktaprasadana (blood purifying) properties.Triphala in the formulation aids in relieving the constipative effects of the iron compound due to its Anulomana (carminative) property. Since Saptamritaloha is the formulation containing loha, there is a preference to administer it after food. Further, it acts as Rasayana to enhance the qualities of the Rasa and Rakta Dhatu.
The herbal ingredients in the study drug are a source of ascorbic acid, sugars, aminoacids, and organic acids, which help in better absorption of non-heme iron. The iron complexes with glucose and fructose sugars in honey and fatty acids from ghee, which enables easy absorption. Improvement in the weight could be attributed to the improved status of digestion and absorption through the gut. This study revealed more or less comparable results with both the formulations in Panduroga (IDA) in children. On evaluating the effect size, the magnitude of the effect was medium (cohen d is 0.508). The ingredients in both the formulations have almost similar Doshaharatva (Dosha alleviating property) and Dhatuvardhana Karma (tissue-promoting activity), and they are better accepted in the tablet form. Throughout the study, no adverse reactions were recorded on oral administration of both the formulations owing to Mriduveerya (mild potency) and Tridoshashamana (alleviating Tridosha) nature of the herbal ingredients used. On assessment of overall effect, it was found that both the formulations could increase Hb percentage above 1 g within the stipulated two months, indicating moderate response to the therapy. This is comparable with the standard oral iron therapy. Since IDA is a chronic disorder, long-term iron therapy is required to achieve a normal physiological level. However, long-term oral iron therapy is associated with adverse effects such as gastric irritation, pain abdomen, constipation etc, which could be minimized here by virtue of the herbal ingredients of the formulations.
Previous experimental studies on Lohasava and Navayasa Loha, containing similar ingredients to the trial drugs cited earlier, were proven safe, hematenic, cytoprotective, and nontoxic to the tissues. Lack of estimation of peripheral smear, serum ferritin, and iron-binding capacity were the designated gold standard assessment parameters for anemia, and these were considered the limitations in this study. As participants were selected from the school health checkup conducted at the study setting, many children were of the same school and also some belonged to the same class. This resulted in conducting an open-label trial rather than a blind one. A similar multicentric trial on a large sample with an extended blood parameter analysis would aid in collecting specified precise data on the drugs cited earlier.
| Conclusion|| |
Saptamritaloha is a herbo-mineral formulation from Ayurveda pharmacopeia containing iron in the form of Lohabhasama along with Triphala, Yashtimadhu, ghee, and honey. The plant medicines in the formulation aid in enhancing the bioavailability of the drug and lead to a reduction in the proposed side effects of oral iron therapy. The results were at par with the standard comparative drug Dhatriloha. This indicates that Saptamritaloha was found to be safe and effective in treating Panduroga (IDA) in children.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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