How to cite this article:
Rao CS, Sahu S, Gupta HK, Bhuyan GC, Sharma B S. Clinical Efficacy and Safety of Sarasvata Ghrita in the Management of Cognitive Deficit–A Prospective Open Label Study. J Res Ayurvedic Sci 2018; 2 (2):63-69.
Introduction: Cognitive deficit describes deficit in global intellectual performances. It is a condition which usually begins in childhood, and the patient shows significant limitations in their ability to learn and function. Its cause may be congenital or may occur due to environmental factors such as brain injuries, neurological disorders, or mental illness, etc. The cognitive deficit can be correlated with Budhimandyata in Ayurveda.
Objective: To evaluate the efficacy and safety of Sarasvata Ghrita in the patients suffering from cognitive deficit.
Materials and methods: A prospective, open-label study was carried out at Advanced Center for Ayurveda in Mental Health and Neurosciences, Bengaluru (ACAMH and NS). Fortyfive cognitive deficit children satisfying the selection criteria were selected from the out patient department (OPD) of ACAMH and NS, NIMHANS, Bangalore, were administered Sarasvata Ghrita (6 gms) twice daily before food with lukewarm water for three months. Assessment parameters Intelligent Quotient (IQ) by Binet Kamat test (BKT), mini mental state examination (MMSE), abnormal behavior check (ABC) and parental perception evaluation were assessed at the baseline, on the 60th day and on the 90th day. Paired sample t-test was used to compare mean change from baseline to the 84th day. A p- value of <0.05 was considered significant.
Results: At the end of the 90th Day, compared with baseline statistically, significant improvement was observed in BKT IQ score, MMMSE score, ABC list score and the parental perception score (p < 0.001). Hematological and biochemical laboratory parameters were also assessed before and after the trial (there was not any significant change in them).
Conclusion: Sarasvata Ghrita taken internally by cognitive deficit children is helpful in improving their IQ, MMSE and ABC scores. It was also found safe as it does not produce any
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Gupta H, Sudhakar D. Clinical Evaluation of Ashwagandha and Mandookaparni in the Management of Manodwega (Generalized Anxiety Disorder). J Res Ayurvedic Sci 2018; 2 (2):70-79.
Introduction: Generalized anxiety disorder (GAD) is a common clinical condition reported at psychiatric hospitals. Reasonable estimates for its one year prevalence range from 3 to 8%. It is characterized by excessive, uncontrollable and irrational worries about day to day events. Most of the features of GAD are similar with that of chittodwega in Ayurveda.
Materials and Methods: This study is a prospective randomized open clinical trial conducted in GAD patients. One hundred patients fulfilling the selection criteria were enrolled from the out patient department (OPD) of the institute. They were randomized into two groups of 50 patients each. First group patients ware administered with Ashwagandha Churna tablets 1.5 gms (Withania Somnifera Linn), and Mandookaparni churna tablets 1.5 gms (centella asiatica) twice daily after food for 12 weeks. In the second group along with the same oral medications Shirodhara with Ksheerabala Taila was performed for 30 minutes daily for the initial seven days only. Outcome measures were improvement in total and individual constituents of hamilton anxiety rating (HAR) scale which were assessed at baseline and at 28th day, 56th day and 84th day. Paired sample t-test was used to compare mean change in hamilton rating scale (HRS) values from baseline to the 84th day. A p-value of < 0.05 was considered as significant.
Results: A t t he e nd o f 1 2 w eeks c ompared w ith b aseline statistically significant improvement was observed in Hamliton rating scale score (p-value < 0.001) in both the groups. The treatment was found to be safe and effective as all the safety parameters were in the stipulated range. No adverse drug reaction or event was reported during the trial period.
Conclusion: Oral administration of Ashwagandha and Mandookaparni churna in tablet forms with or without combination of Shirodhara were found to be effective in the treatment of GAD patients.
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Sudhakar D, Bhuyan G, Dua PK. Clinical Evaluation of Brahmi Ghrita and Jyotishmati Taila in the Management of Cognitive Deficit in Children. J Res Ayurvedic Sci 2018; 2 (2):80-89.
Introduction: Cognition refers to the perceptual and intellectual aspects of mental functioning. A deficit in intellectual performances results in lack of cognition process to cognition deficit. The present study is carried out to evaluate the efficacy of Brahmi gritha and Jyotishmathi taila in cognitive deficit.
Materials and Methods: Brahmi ghrita has given orally in a dose of 10 gms twice daily with warm water/milk before food and Jyotishmati taila given as Pratimarsha Nasya (2-2 drops) in each nostril twice daily for a period of 12 weeks to evaluate the effect on clinical symptoms of Cognitive deficit and changes in mini-mental state examination (MMSE). Seventy-six cognitive deficit children were selected from outpatient department (OPD) of this Institute.
Observations and Results: Clinical symptoms revealed encouraging results such as lack of curiosity 100 to 11.9%, poor attention from 95.55 to 13.4%, moderate responses in decreased learning ability from 100 to 59.7%, mild response in the symptoms like language skill from 65.7 to 59.7%, asking same questions repeatedly from 20.9 to 17.9% and inability to understand and follow the directions from 89.6 to 86.6%. No response was observed in the symptoms like meeting educational demands in school and getting lost in the neighborhood and inability to get home. It provided significant effect on all symptoms of MMSE except registration and sensory perception at the end of the 84th day of the study. At the follow-up study (at the end of 14th week) it provided an insignificant effect on attention and concentration and registration and sensory perception. Lab reports show that no significant changes occur in almost all hematological parameters.
Conclusion: It may be interpreted that these medicines are safe for administration and also effective to improve the clinical symptoms of the cognitive deficit children.
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Namburi US, B. Clinical Efficacy/Safety of Therapeutic Combination; Kshirbala Taila Matra Basti, Vatari Guggulu, Maharasnadi Kwatha and Narayan Taila in the Management of Osteoarthritis Knee (Sandhivata): A Prospective Open Label Study. J Res Ayurvedic Sci 2018; 2 (2):90-98.
Introduction: Osteoarthritis (OA) knee is the most frequent joint disease encountered in the clinical practice and a leading cause of disability in the elderly. It is a chronic degenerative disorder of multi-factorial etiology characterized by loss of articular cartilage, hypertrophy of bone at the margins, subchondral sclerosis and range of biochemical and morphological alterations of the synovial membrane and joint capsule. The clinical presentation of OA is similar to Sandhivata described under Vatavyadhi in Ayurveda.
Objectives: To evaluate the clinical efficacy and safety of Kshirbala Taila Matra Basti chikitsa along with Vatari Guggulu, Maharasnadi Kwatha internally and local application of Narayan Taila in the management of OA knee.
Materials and Methods: A prospective, interventional, openlabel study was carried out at the Regional Aryuveda Research Institute for Mother and Child Health (RARIMCH), Nagpur. Sixty patients in the age group 35-65 years with primary OA of knee joint fulfilling the diagnostic criteria were enrolled. A combination of Kshirbala Taila Matra Basti for 27 days in three courses (each of 9 days) along with Vatari Guggulu, Maharasnadi Kwatha orally and local application of Narayan Taila locally, was administered for 12 weeks. Subjects were followed every fortnightly during treatment and after 4 weeks of completion of treatment. Assessment was done at every two weeks on the basis of the change in pain, stiffness and physical function using the validated modified western ontario and McMster Universities osteoartharitis index (WOMAC) questionnaire, visual analog scale (VAS) scale and global Assessment of disease activity scale.
Observations and Results: A significant reduction in total WOMAC score (p-value < 0.001) was observed after the treatment of 12 weeks and also at the end of 16th week. The mean knee joint pain score assessed on VAS was 8.05 which reduced significantly to 5.52 on 84th day and 5.37 on follow-up (p < 0.001). The mean score of global assessment of disease activity at baseline was 80.17, which reduced to 51.17 on 84th day and 49.00 on follow up (p < 0.001). No adverse events were reported during the course of treatment.
Conclusion: The therapeutic regimen Kshirabala Taila, Matra Basti and Vatari Guggulu, Maharasnadi Kwatha along with topical application of Narayana Taila is safe and significantly effective (P < 0.001) in all the cardinal symptoms of OA of knee joint.
Krishna K Pandey,
Gyanendra D Shukla,
Arun K Tripathi
Introduction: In most musculoskeletal disorders, primary medicine seeking symptom is a pain, but due to “time taking the line of treatment” of Ayurveda in chronic conditions common mass adopts non-sectorial anti-inflamatory drug (NSAIDs) and other analgesics even if undesirable. This study is an attempt to provide an alternative to NSAIDs for pain management by Ayurvedic means.
Materials and Methods: Eighteen patients suffering from painful musculoskeletal disorders of varied etiology, i.e., osteoarthritis (OA)/rheumatoid arthristis (RA)/low back pain (LBA)/ Gout, primarily having knee joint pain, were randomly divided in three groups with six patients in each group, These patients were unable to perform their routine activity without NSAIDs. Group A patients were given Etoricoxib. Group B patients were given three sittings of Leech therapy (Jalaukavacharana) within 3 days. While Group C patients were given sugar-coated tablets. The assessment was done on 1st day, 9th day and 15th day based on changes in subjective criterias and outcome was statistically analyzed.
Results: Pain was significantly reduced in the patients treated with Leech therapy, and the relief consistency was better than NSAID treated group. However, the results obtained in Group C patient were not significant.
Conclusion: In this pilot study, Leech therapy has shown promising results in pain management and can be used as a substitute for modern analgesics. However, more studies with large sample sizes are required to justify this clinical outcome so that Leech therapy can be implemented as a pain management module instead of NSAIDs in painful musculoskeletal conditions.
Surendra K Sharma,
Om R Sharma,
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Srinivas P, Subhose V, Sharma SK, Srinivas P, Babu G, Sharma OR, Narayanam S. Clinical Evaluation of Nisha Katakadi Kashaya and Yashada Bhasma in the Management of Type-2 Diabetes Mellitus (Madhumeha) : A Multicentre, Open Label Prospective Study. J Res Ayurvedic Sci 2018; 2 (2):108-121.
Introduction: Diabetes mellitus (DM) is a metabolic disorder characterized by abnormal carbohydrate, fat, and protein metabolism, which is clinically diagnosed based on hyperglycemia. Ayurveda has explained Avyayama (lack of exercise) as the first and foremost cause for diabetes.
Objectives: The main aim of the study was to assess the safety and clinical efficacy of Nisha Katakadi Kashaya and Yashada Bhasma (single as well as in combination) in the management of Type 2 Diabetes Mellitus.
Materials and Methods: This study was an interventional, randomized, openlabel multi-center clinical study. Total 193 subjects were treated with Nisha Katakadi Kashaya, 15 ml, Capsule Yashada Bhasma 125 mg individually in 1st and 2nd groups and Nisha Katakadi Kashaya, 15 ml and capsule. Yashada bhasma, 125 mg as a combination in the 3rd group. The duration of treatment was 12 weeks (84 days) in all the groups and the effect of the drug was assessed up to 14th week. Results: The effect of treatment was observed statistically highly significant (< 0.001) in relieving subjective parameters diabetes symptoms questionnaire (DSQ) score) and improving the quality of life of the subjects assessed by SF-36 (RAND) health survey score. But there is no change observed in parameters, i.e. HbA1c and Blood sugar levels.
Conclusion: Ayurveda treats Madhumeha in a broad concept which does not include just the hyperglycemia; the study provides good evidence in support of the efficacy and safety of the trial drugs individually and in combination in response to subjective parameters. It is also observed that, all the safety parameters like liver function test (LFT), kidney function test (KFT) and renal parameters also remain within normal limits.
Bhagwan S Sharma,
Vanmala B Wakode
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Sharma B S, Srinivas P, Venkateswarlu G, Marlewar S, Das B, Ravte R, Wakode VB. Clinical Safety of Selected Ayurvedic Formulations as Rasayana in Apparently Healthy Elderly Persons: A Pharmacoepidemiological Perspective. J Res Ayurvedic Sci 2018; 2 (2):122-131.
Introduction: Rasayana drugs are a g roup of medicinal preparations having Balya (improving physical strength), Agnivardhaka (stimulating digestive activity), Medhya(improving intellect), Ojovardhaka (enhancing immunity) and Vayasthapana(delaying ageing) properties. Rasayana therapy (Rejuvenating group of medicines) aims specially at the promotion of strength and vitality by replenishing rasa and other dhatus. Objective: Critical analysis and presentation of clinical safety and efficacy outcomes of classical Ayurvedic formulations, viz. Ashwagandhadi leha, Brahma Rasayana and Chyavanaprasha in apparently healthy elderly persons, generated through multicentre open label studies conducted at different CCRAS centres.
Materials and Methods: Analysis of data collected from three different clinical studies that had been completed in peripheral institutes of Central Council for Research in Ayurvedic Sciences (CCRAS), were critically evaluated to assay the safety profile of three formulations, namely Ashwagandhadi leha, Brahma Rasayana and Chyavanaprasha. Clinical safety assessments were done through analyzing liver function tests (LFT) and renal function tests (RFT) before and after the administration of rasayana. Parameters like hamilton depression rating scale, PGI memory scale and world health organization quality of life instrument-abbrivated version (WHO QOL-BREF)scale were also assessed before and after administration of Rasayana. Paired t-test was used to compare mean change from baseline to end of the trial period. Drug compliance and adverse events (AE)/adverse drug reaction (ADR)s, if any were also noted.
Conclusion: The findings in the three different clinical studies clearly reveal that Ashwagandhadi leha, Brahma Rasayana and Chyavanaprasha are clinically safe, tolerable and effective in apparently healthy elderly persons.
The destruction/break/rupture/discontinuity of body tissue/ part of body is called Vrana. Vrana is the most important part of Shalya Tantra and our text have emphasized a lot of wound care due to trauma or a result of vitiated dosha. Here we reported a new case of the traumatic wound, presented with pain and discharge on anterior aspect of little finger for 3 months. A male patient of 35 years old consulted to out patient department (OPD), Shree Gulabkunverba Ayurveda Hospital, Jamnagar, with above complaint. This case was managed with a local application of Madhukadi Yoga and Phaltrikadi Kwatha. Wound was almost healed within 35 days of wound care. This case concluded that regular local application of Madhukadi Yoga helpful in non-healing wound.
Buduru S Prasad,
Veerappa A Kothivale,
Bhagwan S Sharma,
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Prasad BS, Kothivale VA, Patil R, Nandigoudar S, Sharma B S, Hoti S, Nesari M. Clinical Efficacy of an Ayurvedic Formulation in the Management of Dengue: A Short Report. J Res Ayurvedic Sci 2018; 2 (2):136-139.
Introduction: Dengue is potentially a fatal illness prevalent in the tropical regions of the world, and an outbreak of this lead to serious complications like dengue shock syndrome and dengue hemorrhagic syndrome. Development of a precise solution/ formulation for dengue is highly essential and is the need of the hour. In this endeavor, a polyherbal ayurvedic formulation was identified and used as an adjuvant to the existing treatment protocol by World Health Organization (WHO) (standard care) for dengue. The objective of this study was to observe the platelet trends and prevention of complications in dengue patients and also to evaluate the improvement in clinical signs and symptoms with minimum recovery days.
Materials and Methods: An observational retrospective cohort design was adopted. Thirty-five patients of either sex, of age between 16 and 60 years, were selected from Shri BMK Ayurveda Mahavidyalaya, JN Medical College and Dr. Prabhakar Kore Hospital and Medical Research Centre of KLE Higher Education and Research Centre, Belagavi. The case records belonging to dengue patients who were confirmed by positive NS-1 antigen or IgM test with thrombocytopenia, and classical features of dengue who were treated with standard care suggested by WHO along with Polyherbal Ayurvedic formulation decoction in the dose of 40 ml twice a day for ten days and were followed up further for atleast four days.
Results: Platelet count has increased in all patients. Significant progressive increase in platelet count was observed from 1st to 5th day which was statistically significant when value of 3rd day was compared to that of 5th day. Early improvement in clinical features of dengue was observed, and no case of complications was noticed.
Conclusion: The polyherbal Ayurvedic formulation decoction and WHO prescribed standard care is seen as a good adjuvant for dengue which showed a potential increase in platelet count and speedy recovery of patients.
How to cite this article:
Sharma B S, Thugutla M. Generation of Evidence on Clinical Safety and Efficacy of Classical Ayurveda Formulations: A Short Appraisal of CCRAS Initiatives. J Res Ayurvedic Sci 2018; 2 (2):140-143.
Ayurvedic medicines are serving the needs of ailing humanity for centuries, but there is a constant need to bring these medicines on a global platform and to give them proper scientific validity. Central council for research in ayurvedic sciences (CCRAS), Ministry of AYUSH, Government of India, since inception is dedicated in the validation of classical Ayurveda formulations through series of clinical studies, to consolidate the use of Ayurveda classical formulations, backed by proper scientific evidence. The Council has generated scientific evidence on clinical safety and efficacy of approximate 100 classical Ayurvedic formulations on 35 diseases/conditions of priority areas. The evidence on clinical efficacy and safety of Ayurvedic formulations which are vogue and available in the market are not only highly useful to practitioners and consumers for their rational use but also will strengthen integration of Ayurveda with other systems of medicine and will be helpful in convincing scientific community across the world which may also improve its market in the country and world at large.