INTRODUCTION India is home to the largest number of children in the world1. The number of live births in the country is estimated to be 27 million2. Along with these India also contributes to more than 20 percent of the child deaths in the world, about 1.83 million children die annually before completing their 5th birthday3. Respiratory infections and diarrheal diseases together contribute to 36 percent of all deaths in children under 5 year of age4. Acute respiratory infections (ARI) contribute to major disease associated morbidity and mortality among children up to one year5. The latest data from Sample Registration System (SRS) Bulletin shows significant 8 percent decline in India’s infant mortality rate (IMR) from 37 per thousand live births in 2015 to 34 per thousand live births in 2016. Despite the substantial progress in reducing child mortality, child survival remains an urgent concern. Acute respiratory infections remain the leading cause of death in under 5 year children6. Even after many innovative combined efforts of Government of India, UNICEF and WHO, suboptimal immunization coverage and wide spread antibiotic coverage are the major factors responsible for higher incidence of Acute Respiratory Infections in infantile age group. These incidence of repeated infections particularly after weaning at 6 month age, lead to weight loss, growth retardation and slow development of the child. NEED OF THE STUDY Recurrence of respiratory infections during the first year of life has an impact on the broncho-alveolar as well as the vascular development of the lungs. This could lead to average and long term after-effects as development of Asthma and other chronic lung diseases. Chronic lung diseases could compromise the child’s growth and development (physical, mental and neurological development) i.e. failure to thrive, slow growth, poor learning ability and/or mental retardation in later life. Despite, major advancement in medical science including vaccinations, and antibiotics, recurrent respiratory infections remain a leading cause of infantile morbidity. Therefore, there is a need to find a way to improve/enhance the ability to fight with the infections and promote growth & natural development by reducing the incidences of infection in children. Ayurveda has explained such health promoting agents under the heading of Rasayana. Suvarn Prashana is such Rasayana mentioned in Ayurveda to promote immunity, it produces non specific immunity along with many beneficial effects. Administration of processed gold in children is a unique practise mentioned in Ayurveda as “Suvarna Prashana†by Acharya Kashyapa7, while describing the benefits of Suvarna Prashna, Acharya Kashyapa opines that after feeding gold for one month the child is not attacked by the disease, and also eliminates evil effect of grahas7. This implicates that ingestion of Suvarna (Gold) modulates the immune system so that the morbidity is reduced. There are various formulations of gold and even along with herbal drugs explained by different Acharyas for prolong usage in children. Keeping these facts in the discussion, the present clinical trial is planned to evaluate the efficacy of herbo mineral formulation (Suvarna Prashana Avaleham) in lowering the incidence of respiratory infections in infants. AIMS AND OBJECTIVES OF STUDY The present research study has been planned to conduct with following main objectives. 1. To evaluate the efficacy of Herbo-Mineral Formulation (Suvarn Prashan Avaleham) in reducing the respiratory infection in infants 2. To promote the normal growth and development of infant by lowering the incidence of infection. MATERIAL & METHODS The study will be conducted under a strict protocol to prevent bias and to reduce the source of error in the study. Following materials and methods will be adopted for conducting the present clinical trial. Study type : Randomized Controlled Trial Masking : Open label Control : Controlled Timing : 03 Months End point : Efficacy No. of groups : Two Timelines Total trial period : 03 Months Follow-Up Period : 01 Month Number of patients to be completed in the clinical trial (sample size) : 60 Selection of Cases Source of data: For the present clinical study, subjects attending the O.P.D. of Kaumarabhritya, Department of National Institute of Ayurveda, Jaipur and other healthcare setups (if required) will be screened for the present study. Age Group: Infants of 06 months to 12 Months of age will be selected for the study. (06 months to 09 months will be registered for the clinical trial) Sample size and Grouping of patients: Total 60 cases are planned to include in the clinical trial and will be randomly divided into two groups (30 in each) Group A: Trial drug Herbo-Mineral Formulation (Suvarn Prashan Avaleham) (30 cases) Group B: Control (No treatment concurrent control) (Sugar Drops) (30 cases) TRIAL DRUG HERBO-MINERAL FORMULATION (SUVARN PRASHAN AVALEHAM) |
| Name of Drug | Part used | Proportion | | 1. | Suvarna Bhasma | - | 0.1% | | 2. | Bacopa Monnieri (Aindri) | Whole Plant | 0.5% | | 3. | Centella Asiatica (Brahmi) | Whole Plant | 0.5% | | 4. | Convolvulus Pluricalis (Shankhpushpi) | Whole Plant | 0.5% | | 5. | Acorus Calamus (Vacha) | Root | 0.5% | | 6. | Cow Ghrit | - | 01% | | 7. | Honey | - | 96.90% |
The trial drug Herbo-Mineral Formulation (Suvarn Prashana Avaleham) will be arranged from the manufacturer by the scholar. Presentation of trial drug: The trial drug formulation is available in the form of drops in the vials of 15 ml capacity. Dose and Duration of the Trial: The proposed trial drug Herbo-Mineral Formulation (Suvarn Prashan Avaleham) will be prescribed in the dosages of 2 drops empty stomach in early morning for 03 months & follow-up will be done on every 15th day of starting the trial. CRITERIA FOR SELECTION OF CASES Inclusion Criteria 1. Infants aged from 06 months to 09 months of either Gender. 2. Parents’ willingness to let their children participate. Exclusion Criteria 1. Subjects suffering from major systemic illness necessitating long term treatment. 4. Co-morbidity like TB, UTI and bleeding disorders etc. 5. H/o hypersensitivity to any of the trial drug or their ingredients. Discontinuation Criteria 1. Any acute or severe illness those need hospitalization during the trial period. 2. Parents not willing to continue the treatment. PRIMARY OUTCOME MEASURES 1. To lower down the incidence of respiratory infection in infants with the use of trial drug. SECONDARY OUTCOME MEASURE 2. To promote the normal growth and development of infant with lowering the incidence of infection. ASSESSMENT CRITERIA The result of the clinical study will be assessed based on the observations of clinical features and laboratory findings. Following parameters shall be adopted for assessing the patients before, during and after treatment. Clinical profile: All the symptoms and signs of Respiratory Infection will be assessed on 4 grade scoring system before and after the trial. Symptoms are 1. Watery Running nose 2. Nasal Block 3. Fever 4. Cough 5. Dyspnoea Hematological Parameters Following parameter will be adopted for assessment of the patients under trial 1. Hb gm%, 2. TLC, 3. DLC. METHODS OF ASSESSMENT Prior to selection-(screening) Informed consent/assent Eligibility evaluation Laboratory investigations Hb, TLC, DLC. During selection-(baseline) General information (personal identification) Medical history, general physical and systemic examination Clinical assessment Issue of drugs Instructions to come on every15th day During trial i.e. on 15th, 30th, 45th, 60th, and 75th day Assessing drug compliance Physical examination Clinical assessment Issue of drugs Instructions to come on every15th day At the end of the trial i.e. at the end of 3 months (90 days): Assessing drug compliance Physical examination Clinical assessment Laboratory investigations – Hb, TLC, DLC. Instructions to come after four weeks ADVERSE DRUG REACTION (ADR) Any adverse event, if observed during treatment period or during follow up visits will be clearly documented and its appropriate and timely management will be done. The Principal Investigator will report same to the Ethics committee. DRUG COMPLIANCE If there is more than or equal to 80% compliance, the participant would be continued in the trial. The compliance need to be assessed at each visit during the follow-up (i.e. Day 15th, 30th, 45th, 60th, 75th, and 90th day) by counting the number of empty bottles returned by the patient. PATIENT INFORMATION AND CONSENT/ ASSENT FORM Prior to any trial related activity, the Principal Investigator will give the patient verbal and written information about the trial in the form; the participant/ Parents(s)/ Guardian(s) can read and understand. The investigator would ensure that the participant is fully informed about the aims, procedures, discomforts and expected benefits of the trial. It must be emphasized that the participation is voluntary and participants have the right to opt out of the trial at any time without any prejudice. A voluntary, signed witnessed informed consent/ assent will be obtained from the Participant/ parent(s)/ Guardian(s) prior to any clinical trial related procedure. CONCOMITANT MEDICATION A concomitant medication (con-med) is a drug for biological product, other than a study drug, taken by a subject during a clinical trial. Participants registered under the trial will be issued treatment cards with the entire treatment regimen written on it. They will be instructed to avoid the use of any other drug on their own for any ailment and will be clearly instructed to consult the treating investigating physician for any symptoms or complaints, or if they feel anything unusual. The investigating physician will record any medication(s) he/she may prescribe to alleviate their ailments. RESCUE MEDICATION To alleviate any emergency, the use of rescue medication is permitted as per the wisdom/discretion of the principal investigator. However, the same need to be documented in appropriate column in the case record form. DROPOUTS An attempt shall be made to record the reason for drop outs, if any during the clinical trial. DATA DOCUMENTATION AND ANALYSIS All information regarding clinical trial will be properly documented, carefully handled and meticulously stored in order to ensure its accurate interpretation and verification. Observation documented during the study will be analyzed and findings will be evaluated by using statistical methods (student’s t test) to establish the efficacy. Review of previous research works: Review Articles – 1. Rationality of Swarna Prashan in pediatric practice; Dr Arun, Dr Nisha, Dr Abhimanyu, International Journal of Ayurvedic Medicine 3;3(2013)1191:1200. 2. Suvarna Prashana therapy in children; Concept, Practice and Prospects, Chetali Samant et al. Journal of Ayurveda and Holistic Medicine (JAHM) ISSN;2312 1563. 3. A critical appraisal on Swarna prashana in children, K.B. Jyothy et al, AYU.2014, Oct.-Dec. 35(4);361-365. 4. Suvarna Prashana; An Ayurvedic approach towards child Immunization, V.S. Ingole et al. International Journal of Applied Ayurved Research, ISSN; 2347 6362. Clinical work – 1. Traditional use of Swarnamrita Prashana as a preventive measure; evidence based observational study in children; Rao N Prasanna et al. IJRAP 3(5), Sept-Oct. 2012. 2. A survey study on Suvarna Prashana; An Ayurvedic immunization, Sagar Bhinde et al. Journal of Vishwa Ayurveda Parishad, Year 10, Vol. 7-8, Aug. 2013, ISSN; 0976 8300. 3. Clinical effect of Suvarna Bindu Prashan, Aniket Patil et al. Journal of Ayurveda and Integrated Medical Sciences, ISSN; 2456 3110, Vol.2, No.3, (2017) May-June. 4. Role of Suvarna Prashan in children up to five years of age, Dr Jaybhay ikas et al. IAMJ, International Ayurvedic Medical Journal, ISSN; 2320 5091. PROPOSED DESIGN OF STUDY Present research will be presented in the form of a dissertation, which will include following contents- 1. Benediction 2. Abbreviation 3. Acknowledgement 4. Introduction 5. Literary Review I. Review of Modern Literature II. Review of Ayurveda Literature 6. Demographic Cross-sectional Study 7. Clinical Study 8. Discussion 9. Summary 10. Conclusion 11. Bibliography 12. Appendices
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