Effectiveness of herbal drug Terminalia Arjuna in chronic venous insufficiency - A prospective observational study.

INTRODUCTION: Chronic venous insufficiency (CVI) manifests in various clinical presentations ranging from asymptomatic but cosmetic problems to severe symptoms, such as lower limb edema, skin trophic changes, and ulceration. CVI substantially affects the quality of life and work productivity of the patients. Ayurveda, an ancient traditional medicine in India, evaluates the various pathological stages of CVI with a wide range of pathological conditions such as Siragranthi (venous abnormalities), Raktavaritavata (disorders of vata occluded by rakta ∼ blood), ApanaVaigunya (vitiated apanavayu), Arsha (hemorrhoids), VataRakta (rheumatism due to rakta), Kushtha (integumentary disease) and Dushta Vrana (putrefied wound) depending upon the presentations of the patient. Ayurvedic texts mention Terminalia arjuna as a potential herb for treating various conditions related to the circulatory system. The drug is an effective anti-inflammatory, anti-oxidant, and anti-hypertensive and has a definite role in improving cardiovascular hemodynamics and wound healing. These attributes suggest that the potential of Terminalia arjuna needs to be explored as a promising venoactive drug. METHODS: This prospective observational study included 25 patients (31 limbs) with CVI who were treated with Tab Terminalia arjuna (Bark extract of Terminalia arjuna in a dose of 500 mg, given twice a day) and were observed on two visits on day 30 and day 90. Follow-up was carried out for three months to evaluate post-treatment complications or adverse effects. The clinical outcome assessment was done using Venous Clinical Severity Score (VCSS), and clinical grading was performed using clinical classification (C0 - C6) of CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification. RESULTS: The median VCSS score (of both limbs) during the third visit was comparatively lower than the first, with a statistically significant improvement at 0.05 level. Further, there was a substantial positive improvement in the clinical classification of CEAP among the patients in pre and post treatment phase. CONCLUSION: The prospective observational study shows that Tab Terminalia arjuna is safe and effective in CVI, reducing the symptoms like pain, edema, inflammation, pigmentation, induration and also expediting ulcer healing.

Baghel Prakash Prognosis Scoring System - Conceptual framework and preliminary psychometric validation.

BACKGROUND: The assessment of prognosis in a patient using a rigorous methodology is documented in old Ayurveda texts. But in present times, practitioners employ varied clinical assessment methods, which results in low inter-observer agreement. OBJECTIVES: This study proposes a conceptual framework for developing a prognosis scoring system, which we refer to as the "Baghel Prakash prognosis scoring system" (BPPSS), and presents its preliminary psychometric validation. MATERIALS AND METHODS: Classics of Ayurveda were extensively reviewed for item generation. Thirty-nine items were pooled initially. The Content Validity Index for Items (I-CVI), Scale-level Content Validity Index (S-CVI), and Content Validity Ratio (CVR) were calculated. The final framework contained 30 items. The scoring system was pilot-tested in a sample of 30 patients with various disease conditions. The reliability checks were done to evaluate internal consistency. Inter-item correlations, item-total correlations, and Cronbach's alpha (if an item is deleted) were used to conduct item analysis for the instrument. RESULTS: The framework developed includes a set of early clinical warning signs and a prognosis scoring system of 30 items with a provision for clinical adjustment of scores for selected items. Internal consistency of the scoring system during the initial psychometric validation revealed a value of .761 for Cronbach's alpha (based on standardized items), and item analysis revealed that most of the items had acceptable correlation coefficients between .3 and .7. CONCLUSION: Based on this preliminary validation study, we found that this prognosis framework, based on the principles of Ayurveda, may be used in varied clinical situations. The preliminary psychometric validation experiments yielded satisfactory results. The framework also has potential in clinical research, such as selecting patients with similar prognostic scores for comparability in case and control groups of clinical trials. This tool can be utilized as a reliable outcome measure after conducting enough validation studies.

Swasthya Assessment Scale (SAS)-Ayurveda based health assessment tool-insights on its development and validation.

Introduction: Ayurveda has a unique way of understanding the body, health, and diseases. Various determinants, including biological, ecological, medical, psychological, sociocultural, spiritual, and metaphysical factors, which depend on each other, have their role in determining health in Ayurveda. Currently, no validated health assessment scale, based on the principles of Ayurveda is available. This article, for the first time, reports the development, validation, and reliability testing of the Swasthya assessment scale - a health assessment tool developed in Ayurveda. Materials and methods: A thorough literature search and expert consultations were done to draft the items encompassing the concept of health in Ayurveda. A group of experts assessed the content validity of the drafted items. Cognitive de-briefing and pretesting were performed to modify the language and the content again. Reliability testing was done with an inter-observer agreement in a sample of 183 individuals. Results: The content validity index for items and the scale-level content validity index (S-CVI) were calculated. S-CVI for scale was excellent, with 85% agreement. The S-CVI/universal agreement was 0.45, and S-CVI/Average was 0.95. In inter-rater reliability, the percentage agreement was 73.7%. Pearson correlation coefficient was 0.808 showing a strong correlation. Conclusion: Following appropriate validation, the scale can be widely used in clinical practice to assess the patient's health status, guide the treatment plans, and monitor the progress of the health. It can also be used as a sensitive tool in the research of Ayurveda to assess the changes in patients brought about by Ayurveda interventions.