A CLINICAL STUDY TO STANDARDIZE THE PROCEDURE OF DHANYAMLA DHARA AND TO ASSESS ITS EFFICACY IN RHEUMATOID ARTHRITIS

In this era of globalization and standardization there is a dire need to arrive at a consensus in the approach to the treatment of the diseases in Ayurveda. It is an essential tool not only for proper understanding of the pathology, appropriate diagnosis, and treatment, but also for scientific documentation and generation evidence for global acceptance and appreciation among the scientific community. Classics clearly demarcate the effects of Sweda as an operative and as a pre-operative/post-operative (or both procedures). Considering the therapeutic importance of one such Swedana modality, study was attempted on standardization of the procedure of Dhanyamla dhara, a form of Parisheka sweda. Based on the references in the classics, the data collected through questionnaires and personal interviews a protocol was developed and it was clinically tested in the disease, Rheumatoid Arthritis. The study was carried out in the Department of Panchakarma, Government Ayurveda College, Tripunithura. Patients diagnosed of Rheumatoid Arthritis (As per American College of Rheumatology revised criteria 1987) under the age group of 16-60 years were selected according to the inclusion criteria and were admitted to the IP Unit. Assessment was done by using clinical parameters (objective and subjective) before treatment and after treatment. The results were statistically analyzed using the most appropriate statistical tests. Significant results were noted in all the clinical parameters such as joint pain, joint swelling, tenderness, general functional capacity signifying the effectiveness of Dhanyamla dhara in improving the clinical features and quality of patients life

PHYSICOCHEMICAL CHARACTERISTICS OF RASAMANIKYA-AN AYURVEDIC ARSENICAL FORMULATION

Objective: The objective of this study was standardization and Chemical characterization of rasamanikya prepared as per standard operating procedures (SOP) mentioned in the classical text. Methods: Rasamanikya was prepared by putting churnodaka shodhita haratala (Orpiment-As2S3) between two abhraka (white mica) sheets which are heated for a while to obtain a red colored finished product. The Ayurvedic specifications for the analysis of rasamanikya were performed through qualitative and quantitative analysis. Physicochemical analysis, assay of elements by atomic absorption spectrometer (AAS) and inductively coupled plasma-atomic emission spectrometry (ICP-AES) were carried out and some other tests such as x-ray diffraction (XRD), x-ray photoelectron spectroscopy (XPS) and energy dispersive x-ray analyzer (EDAX) were also performed to ensure the quality of the drug. Results: In the finished drug Arsenic and Sulphur are present in the form of As4S4, As2S3, As2S5. On the basis of XPS survey scans, scanning electron microscopy-energy dispersive x-ray analyzer (SEM-EDAX) and carbon, hydrogen, nitrogen, sulphur (CHNS) analysis the Arsenic to Sulphur (As to S) ratio is thus standardized as 39-47: 53-61. In addition to this powder, XRD shows a major conversion into an amorphous phase. Conclusion: The results could be used to lay down a new set of pharmacopoeial standards for the preparation of rasamanikya for getting optimal efficacy of medicine. Therefore, the information will help the Scientists and Researchers to build comprehensive standards, to screen the compounds responsible for different bioactivities, and to elucidate the molecular mechanism of action

THE MANAGEMENT OF PRIMARY DYSMENORRHOEA (KASHTARTAVA) - A PROSPECTIVE MULTICENTRIC OPEN OBSERVATIONAL STUDY

Objective: To evaluate the clinical usefulness of Rajahpravartini vati in the management of primary dysmenorrhoea (Kashtartava) and changes in the quality of life of the subjects. Study design: A multi-centric prospective single arm observational study. Setting and participants: 359 subjects aged between 16 - 35 years suffering from painful menstruation at least for three consecutive regular menstrual cycles were included in the study. Intervention: Rajahpravartini Vati a classical Ayurvedic formulation was administered 250 mg b.d. with lukewarm water for 90 days followed by subsequent 90 days without intervention. Outcome measures: The management of menstrual pain assessing by 10 points Visual Analogue Scale and improvement in the quality of life using SF-36 (RAND) questionnaire. Results: The mean VAS score of pain at baseline was 6.94±1.98, decreasing to 1.7±2.22 at 90th day which further decreased and maintained to 1.24±1.9 up to 180th day. Associated symptoms like nausea, vomiting, constipation, giddiness, breast tenderness, diarrhea, headache and fainting were completely relieved. The improvements of quality of life in 8 domains viz. pain, general health, physical functioning, social functioning, emotional wellbeing, energy/fatigue, limitation due to physical health and emotional problems at the end of 90th day of intervention was also significant (p<0.001) in comparison to baseline. No adverse event occurred during the treatment period. Conclusion: Rajahpravartini Vati has shown a positive role for the treatment of dysmenorrhoea and to improve the quality of life of the subjects

Chemical characterization of an Ayurvedic herbo-mineral formulation - Vasantakusumākara Rasa: A potential tool for quality assurance

Background: Herbo-mineral formulations of Ayurveda contain specified metals or minerals as composition, which have their beneficial effects on biological systems. These metals or minerals are transformed into non-toxic forms through meticulous procedures explained in Ayurveda. Though literature is available on quality aspects of such herbo-mineral formulations; contemporary science is raising concerns at regular intervals on such formulations. Thus, it becomes mandate to develop quality profiles of all formulations that contain metals or minerals in their composition. Considering this, it is planned to evaluate analytical profile of Vasantakusumākara Rasa. Objective: To prepare Vasantakusumākara Rasa as per Standard operating Procedures (SoP) mentioned in classical text and to characterize it chemically using modern analytical techniques. Materials and Methods: The drug (Vasantakusumākara Rasa) in three batches was prepared in GMP certified pharmacy. Physico-chemical analysis, Assay of elements and HPTLC were carried out as per API. XRD was conducted using Rigaku Ultima-IV X-ray diffractometer. Results: The analysis shown the presence of Mercury, Tin, Gold, Silver, Iron, Zinc and Calcium etc., and HPTLC revealed presence of organic constituents from plant material. The XRD indicated the presence of cinnabar (mercury sulphide from Rasa Sindhura), cassiterite (tin oxide from Vaṅga Bhasma), massicot (lead oxide from Nāga bhasma) and Magnetite (di-iron oxide from Loha bhasma). Conclusion: The physico chemical analysis reveals that VKR prepared by following classical guidelines is very effective in converting the macro elements into therapeutically effective medicines in micro form. Well prepared herbo-mineral drugs offer many advantages over plant medicines due to their longer shelf life, lesser doses, easy storing facilities, better palatability etc. The inferences and the standards laid down in this study certainly can be utilized as baseline data of standardization and QC