Need of the study:
The role of dietary regimen in the form of Pathya kalpana for management & prevention of diseases is one of the peculiarities of Ayurveda. Different Acharyas have mentioned various Pathya Kalpana like Manda, Peya, Vilepi, Yusha etc. Yusha (soup) being one of them, indicated as a wholesome diet for a healthy or a person under Ayurvedic medication or during and after purification procedures. Since ancient time Yusha has been suggested as pathya for both healthy and diseased person. There are so many medicines and Pathya Pahar mentioned in ayurvedic text for kasa , In todays era of hectic schedule people prefer immediate remedy In this busy schedule all are preferred to ready to drink dietary product, No nutraceutical ready to drink dietary product is available in market for kasa. It is anticipated that this product will provide a convenient and effective alternative to traditional medicines and dietary recommendations for Kaphaja Kasa, ultimately resulting in improved cough symptoms and better adherence among patients As Pranavaha Strotas conveys Prana, any disease affecting this Strotas has to be treated with priority. Kaphaja Kasa may not be life threatening but increasingly annoying and irritating to the individual in his routine activity.
PREVALENCE :
According to National center for health statistics, 62 million cases of common cold and cough occurs each year. Cough is the fifth most common symptom for which patients seeks medical care. According to estimates from national interviews taken by the national center for health statistics approximately 9.5 million people or 4% of the population were diagnosed with Chronic Bronchitis.
RESEARCH QUESTION: What will be the efficacy of Nutraceutical Ready to drink navanga yusha in management of Kaphaja Kasa as compared to talishadi churna when administered for a period of 15 days in individuals aged 20-40 years? NULL HYPOTHESIS: The administration of Nutraceutical Navanga Yusha is not effective in management of kaphaja kasa as compared to talishadi churna when administered for a period of 15 days in individuals aged 20-40 years.
ALTERNATIVE HYPOTHESIS: The administration of Nutraceutical Navanga Yusha is more effective in management of kaphaja kasa as compared to talishadi churna when administered for a period of 15 days in individuals aged 20-40 years
Need of the study The role of dietary regimen in the form of Pathya kalpana for management & prevention of diseases is one of the peculiarities of Ayurveda. Different Acharyas have mentioned various Pathya Kalpana like Manda, Peya, Vilepi, Yusha etc. Yusha (soup) being one of them, indicated as a wholesome diet for a healthy or a person under Ayurvedic medication or during and after purification procedures. Since ancient time Yusha has been suggested as pathya for both healthy and diseased person. There are so many medicines and Pathya Pahar mentioned in ayurvedic text for kasa , In todays era of hectic schedule people prefer immediate remedy In this busy schedule all are preferred to ready to drink dietary product, No nutraceutical ready to drink dietary product is available in market for kasa. It is anticipated that this product will provide a convenient and effective alternative to traditional medicines and dietary recommendations for Kaphaja Kasa, ultimately resulting in improved cough symptoms and better adherence among patients As Pranavaha Strotas conveys Prana, any disease affecting this Strotas has to be treated with priority. Kaphaja Kasa may not be life threatening but increasingly annoying and irritating to the individual in his routine activity.
Primary objective: 1. Development of Nutraceutical ready to drink NAVANGA YUSHA 2. Evaluation of proximate composition, dosage and packaging of nutraceutical drink. Secondary objective: 1. To evaluate the efficacy of developed nutraceutical ready to drink Navanga yusha in management of kaphaja kasa.
METHODOLOGY: The study will be conducted in two Steps: Step -1: Development of nutraceutical ready to drink Navanga Yusha. Step -2: Study to see the efficacy of developed Navanga Yusha in kaphaja kasa.
Methodology regarding the development of RTD ï¶ Procurement of Raw materials. ï¶ Preliminary physico-chemical testing of the raw materials before and after processing. ï¶ Development of the nutraceutical RTD optimizing its stability, shelf dosage and packaging. ï¶ Evaluation of proximate composition and stability of the developed nutraceutical RTD ï¶ SOP will be finalized after consulting with the experts at NIFTEM.
Study Type: Exploratory Study ï‚· Research Design : Interventional ï‚· Masking: Open-label ï‚· Control: Controlled ï‚· Timing: Prospective ï‚· End point: Efficacy ï‚· No. of groups: Two groups ï‚· Allocation: Block randomization. ï‚· Study Area: AIIA (OPD) ï‚· Study Setting: Patients attending the OPD, AIIA and fulfilling the inclusion criteria will be included in the study. ï‚· Period of Study: 30 days .{ (Intervention period- 15 days, follow up- 15 days}
Inclusion criteria ICD-10-CM Diagnosis Code R05.9 e. Patients between the age group of 20-40 years. f. Patients having kasa continuously not more then 15 days g. Seasonal allergic cough included, Drug induced cough, h. Patients of both genders.
Exclusion criteria: ï‚· Patients of Kasa with any other pathology other than bronchitis. ï‚· Patients with any other acute or chronic disease will be excluded from this study. (Broncial Asthma, Cough with fever, those on long term medications ï‚· Tuberculosis, cancer of bronchus, pleurisy , DM etc.) ï‚· Pregnant and lactating mothers.
Criteria for assessment: Clinical results will be assessed on the basis of improvement in subjective and objective parameters of Kaphaja Kasa. Efficacy of treatment will be assessed on the basis of relief produced by drugs on cardinal sign and symptoms of the disease before and after treatment. Scoring system will be adopted to assess the disease.
METHOD OF DATA COLLECTION: ï± The data of the selected patients (those who comply with the inclusion criteria and willing to take part in the trial) will be collected. ï± The selected patient shall undergo the series of events before the treatment which include informed consent about the study, their demographic details. ï± A detailed history will be taken subjected to clinical and biochemical analysis by filling up the details of the clinical report form (CRF) as per the requirements of the study.
Sample Size: As this is an Exploratory study so the sample sample size will be limited to 20 patients in each group.
OUTCOME: PRIMARY OUTCOME Development of Nutraceutical Ready to drink Navanga Yusha SECONDARY OUTCOMEReduction in clinical features of kaphaja kasa.
CONFIDENTIALITY • The information that we collect from this research project will be kept confidential. • Information on your health and mental status (as the case may be) that will be collected during conducting the research will be kept confidential and no-one but the researchers will be able to find it. All the information about you will be coded. • Only the All India Institute of Ayurveda Ethics Committee and other regulatory bodies under Government of India law would have access to these records
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