The assessment of relationship between Agni and Arogya, its establishment of relationship on the interventional background and rule out any association with the modern lab parameters may have significant importance in individual’s physical, physiological, psychological and behavioral assessment with the associated factors of Agni, in both healthy and unhealthy persons which can be applied clinically in diagnosis, treatment (drug, dose duration) and prognosis of the disease according to status of Agni. To cater or fulfill this purpose, survey study has been planned to evaluate the role of Agni and its interrelationship with Arogya by a Cross-sectional approach in healthy and unhealthy subjects and a randomized clinical study on Vicharchika (Eczema) patients. Primary objectives (1) To assess the relationship between Agni and Arogya and validate the principle Balamaarogyamayushcha Pranaashchagnou Pratishthitah among adults. (2) To evaluate the role of Agni in treatment of diseases W.S.R. to Vicharchika (Eczema) of 20 to 60 yrs age for one month treatment duration. Secondary objectives (1) To explore and critically analyze the concept of Agni. (2) To analysis of any association of Agni with modern objective parameters (L.F.T. and B. Sugar test) among adults. The study will be carried out in following phases:- (A) Conceptual & fundamental study- (B) Survey study (C) Clinical Study (A) Conceptual & fundamental study- The conceptual part will be based on the thorough observations, compilation and critical analysis of the materials collected from the Vrittaryi, Laghutrayi, Ayurveda text books, Journals and articles etc. (B) Survey study 384 Volunteers fulfilling inclusion criteria will be further taken for assessment of prevalence of Agni. Inclusion criteria Age and Gender All subjects of age between 20 to 60 yrs will be selected without any bars of caste, religion, occupation and sex. Each volunteer will be screened through a health assessment questionnaire (Developed by CSIR AYURGENOMICS TRISUTRA project) to confirm them as apparently healthy and unhealthy individuals. Willing to participate in the study Exclusion criteria (1) Subjects having any other serious systemic disease like congestive cardiac failure, chronic renal failure, tuberculosis, carcinoma etc. forth last one year will be excluded. (2) Subjects having age below 20 and above 60 years (3) Not willing to participate in the study (4) Patients who have completed participation in any other clinical trial during the past six months. Investigation specifically related to project: To check any association between Agni and modern objective parameters out of 384 sample size in observational study sample of 100 would be selected systematically every 4th individual would be taken. RBS LFT Permission will be obtain to use copyrighted Questionnaire or proforma All India Institute of Ayurveda and New Delhi and Delhi NCR Region. Research Tool: Validated Questionnaires or Proforma will be used for the present observational study by adopting direct interview method. (A) Clinical Study The 74 clinically diagnosed patients of Vicharchika (Eczema) fulfilling inclusion criteria and attending AIIA OPD or IPD will be randomly allocated to into two groups using random number table. Study design: single centre, open label, interventional, randomized clinical trial Duration of treatment 1 month Permission will be obtain to use copyrighted Questionnaire or proforma Setting and Site All India Institute of Ayurveda, OPD and IPD Research Tool Validated Questionnaires or Proforma will be used for assessment of status of Agni by adopting direct interview method of patients. EASI score assessment will be done before and after treatment. Follow Up It will be done in every 15 day for 1 month after treatment. Dosages of drug Group 1 Control group (on skin specific treatment) The participants will be given Gandhaka Rasayan in the dose of 500 mg twice a day orally with normal water after meal for 30 days. Tuvaraka Taila will be advised for local application for 10 minutes twice a day for 30 days. Dose will be as par requirement depends on the extend of lesions. Group 2 group with add on drug (Agni treatment)- Patient will given Gandhaka Rasayana in the dose of 500 mg twice a day orally with normal water after meal plus Shunthi powder (Zingiber officinale) in the dose of 1.5 g twice a day orally with luke warm water between meal (Saman Vayu Kaal) for 30 days. Tuvaraka Taila will be advised for local application for 10 minutes twice a day for 30 days. Dose will be as par requirement depends on the extend of lesions. Drug will be procured from GMP certified source. participant may be withdrawn from the trial if a. He or She develops any serious condition or any serious adverse effect b. Patient himself or herself wants to withdraw from the trial. If the patient discontinues the trial drug more than 5 days at a time will be discontinued from the provision for ADR recording and reporting may be made. If there will arise any emergency, the study subjects will be referred to the casualty or to be treated under the supervision of the chief guide and co guides as per the AIIA guidelines. CRITERIA OF ASSESSMENT Cross sectional study data evaluation will be carried out and health assessment will be done through health assessment scale on the volunteers fulfilling inclusion criteria, and then specific validated questionnaire or proforma will be administered to the study participants through direct interview method for assessment of Agni from AIIA and New Delhi and Delhi NCR region. To evaluate role of Agni, in treatment of diseases secondly, randomized clinical trial will be carried out on diagnosed cases with Vicharchika (Eczema) from O.P.D. and I.P.D. of AIIA. Further they will be allocated in two groups i.e. one control group (37 subjects) and second group with add on drug (37 subjects) using random number table. Standard drug (skin specific treatment) will be given to first group. Add-on drug (Shunthi) for Agni treatment with standard drug will be given in second group. Comparison will be done between both groups in symptomatic relief, EASI score and Agni assessment. It will be analyzed for assessment of role of Agni in treatment of diseases. All the patients registered for present clinical trial will be asked for any changes in their clinical manifestations and growing feeling of well being, if any, produced after the course of treatment. After the completion of proforma, collected data will be analyzed by percentage analysis method and results will be interpreted in a scientific manner. METHOD OF DATA COLLECTION Selection of subjects Each and every apparently healthy volunteer and unhealthy volunteer will be screened through a health assessment questionnaire (Developed by CSIR AYURGENOMICS TRISUTRA project) to confirm them as healthy and unhealthy individuals respectively from New Delhi and NCR region. The subjects in clinical study will be selected from OPD or IPD of AIIA suffering with Vicharchika (Eczema). Vicharchika (Eczema) patients will be selected on the basis of classical symptoms described in Ayurveda and in modern science. Further randomized clinical trial will be done and comparison will be analyzed in perspective of symptomatic relief and well being in both groups. Written informed consent will be taken after offering sufficient explanations about the purpose and benefits of the study. All the subjects will be directly interviewed in their local language by a single person (Research Scholar). Detailed history to be taken based on the specially designed Proforma. Primary End point/outcome To Evaluate role of Agni on Arogya (health) and access their interrelationship among adults. Secondary End point/outcome Response to treatment and compare add on effect of Shunthi powder (Agni treatment) to the Gandhaka Rasayana and Tuvaraka Taila (skin specific treatment) in patients of Vicharchika (Eczema) of 20 to 60 yrs for one month of duration. To assess any association of Agni with modern parameters (L.F.T. and B.sugar) among adults.
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