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   Table of Contents - Current issue
Coverpage
July-September 2019
Volume 40 | Issue 3
Page Nos. 139-203

Online since Saturday, August 8, 2020

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EDITORIAL  

Strategies and avenues for COVID-19 – Ayurveda perception p. 139
Mandip Goyal
DOI:10.4103/ayu.AYU_226_20  
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INVITED ARTICLE Top

An overview of primary registries of WHO's international clinical trial registry platform p. 141
Atul Juneja, Jyotsna Gupta, Neha Yadav, Saurabh Sharma, Yashmin Panchal, Tulsi Adhikari, M Vishnu Vardhana Rao
DOI:10.4103/ayu.AYU_62_20  
Introduction: WHO's International Clinical Trials Registry Platform (ICTRP) has 17 primary registries that collect the information on the minimum set of items of trial information that appear in the register and these registries are also endorsed by the International Committee of Medical Journal Editors. Objective: The objective of this study is to describe the profile of all the primary registries including Clinical Trial Registry-India (CTRI), through features such as magnitude, domain of registration, flagging, audit trail, language, mandatory requirements, and result disclosure. Methodology: The profiling of all registries was based on countries and zones, year of establishment, registrant, flagging, conflict of interest, language, documents, result disclosure, type of study, mode of registration, mandate of registration, quality check method, individual patient data statement and translation of content facility. The mode of search used was online which included advanced search, basic search and also from the audio/video manual on their website. Results: There are 17 primary registries of ICTRP, the first one International Standard Randomised Controlled Trial Number (ISRCTN) of England being initiated in year 2000 and the most recent being Lebanese registry, in September 2019. The trials registered with these registries range from 301 in Cuba to 53972 in European union's EU Clinical Trials Register. The primary registries in WHO registry network are diverse in functionalities and practices. The characteristics of online registers vary in content and features and to achieve coordinated level of data quality, across all the different registries and to keep a balance in standards of the data collected and validation of that data, the registries are adhering to the minimum data set items laid down by ICTRP. Conclusion: The very process of registering the clinical studies helps in promoting the research methods and also raising the standards of research, especially among young researchers. It also helps in reducing the duplicity of research.
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REVIEW ARTICLE Top

Therapeutic influence of some dietary articles on gut microbiota in the pathogenesis of rheumatoid arthritis (Amavata) – A review Highly accessed article p. 147
YS Aswathy, PV Anandaraman
DOI:10.4103/ayu.AYU_192_19  
Background: Amavata is a chronic immune-inflammatory systemic disorder caused by the formation of Ama and its association with Vata at Kaphasthana (joints) and can be simulated with rheumatoid arthritis (RA). Published evidences show that treatment indicated in Amavata is effective in RA. Increased inflammatory status in RA is suggestive of gut dysbiosis involving gut microbiota (GM). Aim: The aim of the present study was to analyze the influence of diet on GM of RA patients based on Pathya ( dietary advice) mentioned for Amavata. Materials and Methods: Laghutrayis such as Bhavaprakasha Samhita, Madhava Nidana and Sharangadhara Samhita, Bhaishajya Ratnavali and Nighantus (Sanskrit glossary) such as Raja Nighantu, Bhavaprakasha Nighantu and Yogaratnakara, Ashtanga Hridaya also different databases were reviewed for Pathya of Amavata. Different databases such as PubMed, Scopus, DHARA, Google Scholar, Science Direct were searched with research papers establishing the role of nonnutritive bioactive components in horse gram, barley, garlic, ginger, drumstick leaves, cow urine and buttermilk in the management of RA were also reviewed. It was found that Pathya influences on the GM by lowering or inhibiting inflammatory markers such as interleukin-6 (IL-6), 17 and leukotrines through Bowman-Birk inhibitors and polyphenolic compounds. Among them, Takra is already a proven probiotic. Gomutra augments B and T lymphocytes, IL-1 and IL-2, strengthening the immune system. Conclusion: It was concluded that Pathya Ahara mentioned for Amavata have a direct link with GM of RA patients. Even though the pharmacological actions have been clinically proven/practised, this review creates evidence for its scientific basis.
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ORIGINAL ARTICLES - CLINICAL RESEARCH Top

An evaluation of the efficacy of ethanolic extract of Nigella sativa L. (Kalonji) on the clinical parameters of moderate-to-severe gingivitis: A split-mouth clinical study p. 152
Vibha Singh, Abhaya Gupta, Umesh Pratap Verma, Tripti Mishra, Mahesh Pal
DOI:10.4103/ayu.AYU_68_18  
Introduction: Gingivitis is a relatively innocuous and reversible inflammation of gingiva. If left untreated, it might progress involving the deeper supporting periodontal tissues of the tooth with consequent mobility and tooth loss. Compelling literature has suggested the role of local antibacterial and anti-inflammatory agents as an adjunct to scaling and root planing (gold standard) for treating periodontal diseases. Various herbs such as Nimba (Azadirachta indica A. Juss), Babbula (Vachellia nilotica (L.) P.J.H. Hurter & Mabb.) and turmeric (Curcuma long a L.) have been used for gingivitis since ancient times. Nigella sativa L. (Kalonji) is one such herb known for its remarkable anti-inflammatory, antioxidant and antimicrobial properties and thus has been utilized in the present study. Aim: The aim of the study was to explore the clinical efficacy of different ethanolic solutions of N. sativa in moderate-to-severe gingivitis patients. Materials and Methods: It is a split-mouth clinical study with 24 patients of moderate-to-severe gingivitis from the age group of 25–45 years. Recruited individuals were divided in to group I1, group II1and group III1 (scaling and root planning i.e., control) and group I2, group II2and group III2 (experimental). Three doses of solution 1 (1:3), solution 2 (1:1) and solution 3 (3:1) were administered to the experimental groups for 3 consecutive days. The clinical parameters, i.e., gingival index (GI) and plaque index (PI) were recorded at baseline, 14 days and 28 days in all the individuals. ANOVA test was used in the study for statistical analysis. Results: Intergroup comparison in terms of GI showed statistically significant difference at 14th and 28th day from baseline between I1 &I2,at only 28th day between II1 & II2and insignificant difference between III1 & III2 at all time intervals from baseline. On intragroup comparison, statistically significant reduction in GI in all groups from baseline till 28 days was found, but among experimental groups best result was seen in group III2(P < 0.001; F value 153.75). As far as PI is concerned, intergroup comparison between different groups displayed statistically significant difference from baseline to 14th and 28th day between all groups i.e I1& I2, II1& II2and III1& III2. On intragroup comparison, statistically significant reduction in PI in all control groups i.e I1, II1 & III1was found, but among experimental groups only group III2 provided statistically significant reduction (P < 0.001, F value 30.40). Conclusion: The results of this study indicate that, the ethanolic extract of N. sativa is effective in the treatment of moderate to severe gingivitis.
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Evaluation of effect of poultice (Upanaha Sweda) in low back pain (Katigraha): A randomized comparative clinical trial p. 159
Tarun Kumar, Rajashekhar V Sanapeti, BS Prasad
DOI:10.4103/ayu.AYU_71_18  
Background: Katigraha (low back pain) is a condition where low back is afflicted either with Vata or Sama Vata (Vata involved with the toxins released due to altered digestion and metabolism) and present with symptoms such as pain with stiffness. About 60%–80% population in India suffer from this condition. Upanaha Sweda (poultice) is one of the Swedana (sudation) treatment modalities mentioned for Katigraha. As Sama (affected with toxins released from impaired digestion) and Nirama (without toxins) are two stages of Katigraha, hence, the specific type of Upanaha is required for such condition. Aims and Objective: The study was conducted to evaluate the effect of Upanaha Sweda in Katigraha (low back pain) as per the presentation of stages of Ama. Materials and Methods: Selected patients were categorized into two groups. In group A, patients having Samaja Katigraha, were given Panchakoladi Upanaha once a day till it became Niramaja, then shifted to Godhumadi Upanaha for 7 days and patients who had Niramaja Katigraha, Godhumadi Upanaha was used once a day for 7 days. In group B Godhumadi Upanaha was used once a day for 7 days irrespective of stages. Subjective parameters assessed were pain in the low back, stiffness, and Oswestry Disability Index (ODI) was also used. The Mann–Whitney U test and Wilcoxon signed-rank test were used to assess results. Results: Patients who were treated considering the Sama and Nirama phases had 78.88% better results in relieving pain, stiffness, and in ODI change than the patients treated without considering the phases. Conclusion: The present study showed significant results in both the groups, but patients treated as per stage wise treatment showed better effect in treating Katigraha than the patients treated with out considering the stage.
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Apamarga Ksharasutra application and open lateral internal sphincterotomy in the management of Parikartika (chronic fissure-in-ano): A randomized controlled clinical trial p. 164
Hetal L Nakrani, Tukaram Sambhaji Dudhamal
DOI:10.4103/ayu.AYU_144_18  
Introduction: Parikartika resembles fissure-in-ano which is one of the common painful disease among the anorectal disorders. Ksharasutra which is a para-surgical procedure is effective in the management of Parikartika. Aim: To compare the efficacy of Apamarga Ksharasutra and open lateral internal sphincterotomy (OLIS) in the management of Parikartika (chronic fissure-in-ano). Materials and Methods: Total 30 patients having signs and symptoms of Parikartika (chronic fissure-in-ano) were selected and randomly divided into two groups. In Group A (n = 15), Ksharasutra ligation after anal stretching was carried out while in Group B (n = 15), OLIS with excision of skin tag was carried out under local anesthesia or spinal anesthesia. Relief in postoperative symptoms and complications if any was recorded for 4 weeks and follow-up was done for the period of 1 month. Results: In both the groups, significant results were obtained, but the difference among groups was statistically insignificant. Duration required for relief in postoperative pain, bleeding, swelling, and wound healing was found to be more in Group A (Ksharasutra) than Group B (OLIS). Conclusion: OLIS provided better results compared to Ksharasutra ligation in the management of Parikartika (chronic fissure-in-ano).
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Clinical study of Arogyavardhini compound and lifestyle modification in management of metabolic syndrome: A double-blind placebo controlled randomized clinical trial p. 171
Bharatkumar Chhaganbhai Padhar, Alankruta R Dave, Mandip Goyal
DOI:10.4103/ayu.AYU_79_19  
Background: Metabolic syndrome (MS) is a cluster of obesity, hypertriglyceridemia, impaired glucose tolerance, and insulin resistance. The sedentary lifestyle settles on the phenotypical expression of a genetically acquired trait in an obese person. Weight control and a healthy lifestyle remain primary and effective strategies for prevention and management of the MS. The lifestyle modifications mentioned for Santarpanjanya (disorders due to over nutrition) diseases and Arogyavardhini compound that can improve metabolism and reduce weight were selected for a present clinical trial to assess and compare their efficacy in the management of the MS. Materials and Methods: Seventy-five patients were registered for the trial and randomly divided into two groups. Patients were treated with lifestyle modification with and without Arogyavardhini compound for 8 weeks. Results: Thirty-five patients in each group could complete the course of treatment. Lifestyle modification alone and with Arogyavardhini compound resulted in 1.32% and 3.06% decrease in waist circumference, 5.81% and 18.03% decrease in serum triglycerides, 4.43% and 6.89% decrease in systolic blood pressure, 3.82% increase and 2.48% decrease in fasting blood sugar, 9.13% and 5.56% increase in high-density lipoprotein, respectively. The decrease in waist circumference, systolic blood pressure was statistically significant in the both groups. Conclusion: Arogyavardhini compound, along with lifestyle modification was found more effective than lifestyle modification alone in the management of MS.
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A clinical study on Virechana Karma (therapeutic purgation) over the gut flora with special reference to obesity p. 179
Ashutosh Chaturvedi, Gopal Nath, Virender Bhadur Yadav, Meera Antiwal, Niharika Shakya, C Swathi, Jai Prakash Singh
DOI:10.4103/ayu.AYU_302_19  
Background: Altered gut flora is associated with the pathogenesis of both intestinal and extra-intestinal disorders. Aetiology of obesity is associated with mechanisms such as short chain fatty acid production, stimulation of hormones, chronic low-grade inflammation, lipoprotein and bile acid metabolism and increased endocannabinoid. Receptor system tone have been suggested to explain the role of gut microbiota of obesity. The Panchakarma (Ayurvedic purification methods) claims the management of metabolic disorders hence this work provides the target specific evidence for the clinical studies. The proposed project is aimed to explore the particular molecular mechanism and, to make this therapy more evidence based. Hence, it was hypothesized that Panchakarma-based intervention such as Virechana Karma (therapeutic purgation) may influence microbiota and help in the management of the obesity. Materials and Methods: The study was conducted to explore the effect of Virechana Karma over the gut flora; therefore, total of 19 patients with Madhyama Koshtha diagnosed with obesity were included and received the intervention. Before and after Virechana, a stool sample was collected and processed for the enterobacterial repetitive intergenic consensus -polymerase chain reaction to find the changes over the facultative aerobic bacteria. Results: It was found that Virechana is effective in the management of the obesity as it helps to reduce colonization of aerobic bacteria. After Virechana and after follow-up also, it showed the correction of the gut flora dysbiosis, thus initiated the weight loss mechanism in the body, resulting in diminution in the signs and symptoms of obesity. Conclusion: Virechana is effective in the management of the obesity due to reduction in the Escherichia coli colonization and is effective over the gut flora dysbiosis.
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Safety profile of Ayurvedic poly-herbomineral formulation – Bacnil capsule in albino rats p. 185
Balaji Panigrahi, Swati Sharma, Bhakti Sitapara, Subrata De, Mukesh Nariya
DOI:10.4103/ayu.AYU_64_18  
Introduction: Bacnil capsule is a poly-herbomineral formulation used to treat gastroenteritis. It contains many potential drugs derived from plant sources and Bhasma (calcined fine powder) preparations. Aims: The study was designed to ascertain the safety of bacnil capsule orally in Charle's Foster albino rats. Materials and Methods: As per the Organization for Economic Cooperation and Development (OECD) 425 protocol oral acute toxicity study, bacnil capsule was administered orally once only at the dose of 2000 mg/kg in rats. For repeated dose toxicity study, AYUSH 170 and OECD 407, it was administered at three dose levels, Therapeutic doses (TED) (196.2), TED × 5 (981) and TED × 10 (1962) mg/kg/day orally for 28 days in albino rats followed by a 15-day recovery period only on TED × 10 dose level. Observation and Results: Bacnil at the oral dose of 2000 mg/kg did not produce any toxicity or mortality in albino rats. Repeated dose 28-day oral toxicity revealed that test formulation did not produce any significant change in serum biochemical, hematological, and histopathological parameters at therapeutic dose level. Mild-to-moderate pathological changes were observed in the various serum biochemical and cytoarchitecture of the liver, heart, kidney, and stomach at a dose of 10 TEDs; however, the same was reversed after discontinuation in the recovery test. Conclusion: Bacnil at 196.2 mg/kg/day is safe at the therapeutic dose level in albino rats.
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An in vitro evaluation of cytotoxicity of curcumin against human periodontal ligament fibroblasts p. 192
Praveenkumar S Mandroli, AR Prabhakar, Kishore Bhat, Sushma Krishnamurthy, Chetana Bogar
DOI:10.4103/ayu.AYU_294_18  
Introduction: Curcumin, a component of turmeric (Curcuma longa L.), is a molecule of multitude of medicinal properties. Although curcumin has found a place in the treatment of gingival and periodontal diseases, there are no reported cytotoxicity studies on the cells of clinical significance (i.e., periodontal ligament [PDL] fibroblasts). Aims: The objective of this research was to assess the in vitro cytotoxicity of curcumin against human PDL fibroblasts. Materials and Methods: Human PDL fibroblasts from premolar teeth were cultured and used for cytotoxicity tests from healthy children presented for orthodontic extractions. Test concentrations of curcumin (100%, 50%, and 25%) were prepared by diluting 95% curcumin with di-methyl-sulfoxide and added to 96-well microtiter plate (in triplicate) containing the fibroblast culture (approximately 2 × 104 cells/well). Fibroblast cells without treatment (without curcumin) acted as a control group. The viability of cells after 48 h of incubation at 37°C in a humidified atmosphere of 5% CO2and 95% air was ascertained by the 3-(4, 5-dimethyl-thiazol-2-yl)-2, 5-diphenyl-tetrazolium bromide (MTT) assay. The viability of PDL fibroblast cells of experimental wells was expressed relative to that of control, in terms of change in the color intensity. Absorbencies were recorded at 450 nm on a microplate reader with background subtraction at 620 nm. The cell viability at various concentrations of curcumin against the PDL fibroblasts was calculated as mean absorbance (optical density) and percentage values. Results: Cell viability of PDL fibroblasts to 100%, 50%, and 25% curcumin concentration was 111.75%, 112.50%, and 114.40%, respectively. Conclusions: No in vitro cytotoxicity was detected for curcumin against human PDL fibroblasts, at any of the concentrations used (100%, 50%, and 25%) by MTT assay at the end of 48 h.
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Macro-micro-morphological diagnosis of leaves of two species of Cinnamomum (C. sulphuratum and C. verum) used as resource of bay leaf p. 196
Sunil Kumar Koppala Narayana, Divya Kallingilkalathil Gopi, Mattummal Rubeena, Sathiya Rajeswaran Parameswaran
DOI:10.4103/ayu.AYU_194_17  
Background: Cinnamomum verum (true cinnamon or Tejpatra) is a well-known spice with immense medicinal properties. Its adulteration with leaf and bark of other species belonging to genus Cinnamomum is found to be a common practice in India. Aims: Cinnamomum sulphuratum is used as a substitute of C. verum owing to its apparent macroscopic similarities. Materials and Methods: Fresh leaves of C. verum and C. sulphuratum growing in South India were collected and studied to establish their macro–microscopic identity with pharmacognostical perspective. Results: Detailed microscopic evaluation by transverse section, maceration, and powder microscopy was conducted to delineate the two species. Detailed macroscopic identification served the purpose of identification of the entire drug on the spot, and microscopy has helped in the identification of fragmented and powdered form of the drugs. Conclusion: Further chemical and biological studies may be necessary to confirm whether these leaves can be used as a substitute or adulterant for other species Cinnamon.
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