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   Table of Contents - Current issue
Coverpage
July-September 2020
Volume 41 | Issue 3
Page Nos. 143-207

Online since Thursday, February 24, 2022

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INVITED ARTICLE  

Overview of Ayurveda trials registered with Clinical Trial Registry-India: Need for customized data set items p. 143
Tulsi Adhikari, M Vishnu Vardhana Rao, Narayanam Srikanth, Atul Juneja, Saurabh Sharma, Mohua Maulik, Jyotsna Gupta, Yashmin Panchal, BC Rao, Shruti Khanduri, Rakesh V Narayan, Richa Bhardwaj, Prakriti Batra
DOI:10.4103/ayu.ayu_375_21  
Background: Lack of research data is one of the major challenges identified in traditional medicine (TM). Further, there is an urgent need to strengthen and streamline clinical research processes as well as develop research databases in TM. The Clinical Trials Registry-India (CTRI), a free, online primary register of the WHO's International Clinical Trials Registry Platform, undertakes registration of all clinical trials being conducted in India, including TM trials. However, as the CTRI data set items are primarily designed to capture information of interventional trials of the conventional system of medicine, key fields relevant to the TM system are not adequately captured in the CTRI. Aims and Objectives: The current study was conceptualized with the objective to review the type and quality of trials registered in the CTRI as well as identify the specific data set items in CTRI which may be customized as per Ayurveda studies. Materials and methods: The trials registered from July 1, 2018, to March 31, 2020, were analyzed to decipher the kind of research being undertaken in the field of Ayurveda. These trials were manually reviewed independently by two Ayurveda reviewers to gain insights into the discrepancies. Along with these analysis, brainstorming sessions with Ayurveda experts were also held. Results: The fields which were identified and need tweaking and customization were the fields “health condition” and “intervention/comparator agent.” Conclusions: These modifications in the CTRI would enable the capture of more effective Ayurveda-specific information which would in turn help to standardize and streamline research practices as well as raise the standard of research.
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REVIEW ARTICLE - REVIEW STUDY Top

Azadirachta indica A. juss, Morinda citrifolia L. and Triphala as herbal endodontic irrigants: A scoping review p. 148
Archna Agnihotri, Swaty Jhamb, Urvashi Shrama, Sumidha Rohtagi
DOI:10.4103/ayu.AYU_102_20  
Background: The success of the root canal treatment depends on the complete elimination of the microflora, biofilms and smear layer from the pulp space. A wide variety of chemical endodontic irrigants are available to achieve disinfection and thorough debridement besides mechanical means. However, detrimental properties such as allergic potential, cytotoxicity, antimicrobial resistance and safety concerns have intrigued researchers over the years to look for safer options. Aim: The review is aimed at providing comprehensive information of the studies evaluating the efficacy of Azadirachta indica A. juss (A. indica), Morinda citrifolia L. (M. citrifolia) and Triphala (fruits of Emblica officinalis Gaertn., Terminalia chebula (Gaertn.) Roxb. and Terminalia belerica Retz.) as herbal endodontic irrigants. Materials and methods: The literature review was conducted using indexed databases (PubMed, Google Scholar, Cochrane) electronically for publications in peer-reviewed journals for relevant articles evaluating the efficacy of A. indica, Triphala, M. citrifolia as endodontic irrigant from the year 1985-March 2020. Results: A total of 58 studies were identified for full text reviewing after duplicate removal and screening title and abstracts. A total of 32 studies were included and processed for data extractions. Conclusion: Various in-vitro/in-vivo studies utilizing these herbal irrigants have documented promising results and hold the potential to replace chemical endodontic irrigants in routine practice but more preclinical and clinical trials are needed to substantiate these results before they can conclusively be recommended as intracanal irrigating solutions.
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ORIGINAL ARTICLES - CLINICAL RESEARCH Top

Efficacy of Brimhana Nasya and Ashwagandha (Withania somnifera (L.) Dunal) root powder in primary insomnia in elderly male: A randomized open-label clinical study p. 159
Upadhyay Atul, Bansal Charu, Shukla Umesh
DOI:10.4103/ayu.AYU_177_19  
Background: Decreased ability to fall asleep and/or stay asleep with daytime effects of sleep deprivation is identified as primary insomnia. Elderly due to the predominant Vata Dosha in the body are easily affected by this problem. Brimhana Nasya (nourishing nasal drop) with Ksheera Bala Taila and oral administration of Ashwagandha (Withania somnifera (L.) Dunal) root powder both are indicated in Ayurvedic classics for the management of insomnia. Aim: To determine the combined efficacy of oral administration of Ashwagandha root powder along with Brimhana Nasya with Ksheera Bala Taila in primary insomnia in geriatric. Materials and methods: This was randomized, open-label clinical study conducted at the hospital of Pt. Khushilal Sharma Government Ayurveda College and Institute Bhopal. Randomly selected 60 elderly patients with primary insomnia were randomly divided into two groups (30 in each group). Pittsburgh Sleep Quality Index was used to assess the symptoms of primary insomnia. Relief in the subjective symptoms was assessed in percentage. Then, the statistical significance of result within the group was assessed using Wilcoxon matched-pairs signed-ranks test and the comparative effect of therapy in both groups was assessed using Mann-Whitney test. Graph Pad InStat-3 software was used for statistical analysis. Results: On subjective sleep quality 86.66% relief with P < 0.0001, on sleep latency 60.02% improvement with P < 0.0001, improvement in sleep duration was reported in 89.15% of patients with P < 0.0001 and improvement in sleep efficiency was reported in 90.14% of patients with statistically extremely significant P < 0.0001 were observed in combined therapy group (Ksheera Bala Taila Brimhana Nasya along with oral administration of Ashwagandha root powder). While 38.66% improvement in sleep efficiency, 40.39% relief in sleep disturbances and 37.05% improvement on subjective sleep quality was reported in group B patients, i.e., Ashwagandha root powder group. Conclusion: In 30 days treatment combined therapy was found more effective in the management of primary insomnia in the elderly compared with Ashwagandha root powder alone.
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Efficacy of Virechana, Triphaladi decoction with processed Guggulu in the management of ovarian cyst - A pilot study p. 166
Matangee Pandya, Shilpa B Donga, LP Dei, Anup B Thakar
DOI:10.4103/ayu.AYU_254_19  
Background: Ovarian cyst is an emerging problem among the women of reproductive age group. Most of the ovarian cyst (80%–85%) are benign, and two-thirds of these occur in women between 20 and 44 years of age. They may be identified in asymptomatic women during routine pelvic examination or may produce symptoms. Management of the ovarian cyst through surgery is available to meet urgent need of the patient, but to establish a satisfactory conservatory medical treatment is the need of the hour. According to Ayurveda, ovarian cysts can be managed on the line of Kaphaja Granthi (nodular/glandular swellings by Kapha Dosha) and Vidradhi (abscess). Aim: The aim of this study was to evaluate the clinical efficacy of Virechana (therapeutic purgation), Triphaladi Kashaya (decoction) with processed Guggulu (Commiphora mukul Engl.) in the management of ovarian cyst. Materials and methods: 16 patients were included in this clinical study and among them, 15 patients completed the treatment and one patient was dropped out from the trial. Patients were given Virechana followed by Triphaladi Kashaya (50 ml) with processed Guggulu (1 g) orally twice a day before meal for 60 days. The patients were followed up till 1 month. The assessment was carried out on subjective parameters such as lower abdominal pain, backache, and dysmenorrhea as well as objective parameters such as ovarian cyst size and volume by four-dimensional gray scale and color doppler sonography. Cancer antigen 125 was also assessed before and after treatment. Results were statistically analyzed using Wilcoxon signed-rank test and Student's t-test by sigma statistical tool (version 3.5, Systat Software Inc., United States). Results: Significant results were observed in subjective parameters such as lower abdominal pain (93.11%), backache (81.81) and dysmenorrhea (90.90%) as well as objective parameters such as reduction in size of the cyst (60%) and complete resolution of the cyst (26.66%). Conclusion: Triphaladi Kashaya with processed Guggulu is more effective in hemorrhagic cyst and simple cyst rather than other cyst, due to Shothahara properties which may have effectively curtailed the progress of ovarian cyst.
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Role of Laksha Churna and Madhu Pratisarana after ultrasonic scaling in the management of Dantasharkara (dental calculus): An open-label, standard controlled randomized clinical trial p. 173
Divyarani Kathad, Hemangi N Shukla, Mandip Goyal
DOI:10.4103/ayu.AYU_274_20  
Background: Dental calculus is one of the major problems in dentistry, which is characterized by calcified mass that forms on and adheres to the surface of teeth resulting in bad breath, receding gums and chronically inflamed gingiva. It can be correlated with Dantasharkara (dental calculus), which is characterized by the collection of hardened accumulation of Mala (tartar) at the junction of teeth and gums. Ultrasonic scalars are used for the removal of dental calculus for convenience. In texts, Laksha Churna (powder of Laccifer lacca Kerr) has been mentioned as Vranaropaka (wound healing) and indicated for the eliminating plaque through cleaning and polishing tooth surfaces. Aim: This study was aimed to evaluate the clinical efficacy of local application of Laksha Churna and Madhu (honey) Pratisarana after Dantasharkara Nirharana (scaling of dental calculus) in the management of Dantasharkara (dental calculus). Materials and methods: Patients having calculus deposition, fulfilling the inclusion criteria were selected. In group A, Pratisarana with Laksha Churna (powder) 1 g and Madhu as per requirement was given, whereas in group B, chlor-hexidine gluconate 0.2% for gargling was given for 2 weeks. Ultrasonic scaling was done in both groups before given trial drugs. The outcomes were calculated on the base on changes in score of the subjective parameters like pain, inflammation of gum, bleeding gums, halitosis as well as objective parameters like oral hygiene index, debris index, calculus index, gingival index, and periodontal index. For analysing the effect of the result, Wilcoxon signed-rank test for nonparametric paired data and paired t-test for quantitative parametric paired data was applied. Results: After analysing the data, it was found that Ultrasonic scaling of dental calculus followed by Pratisaraņa of honey with Laksha Churna provided statistically significant improvement in calculus index (97.77%) in debris index (84.44%), in oral hygiene index(96.66%), in gingival index (83.33%)and showed 96.15% improvement in periodontal index, whereas Ultrasonic scaling of dental calculus followed by gargling with chlorhexidine gluconate 0.2% provided 80% improvement in calculus index, 70% in debris index, 90% in oral hygiene index, in gingival index by 73.06%, and 93.75% improvement periodontal index which was statistically significant. Conclusion: The present study indicates Dantasharkara Nirharana followed by Pratisarana of Laksha Churna and Madhu is comparatively more effective than conventional standard treatment protocol (ultrasonic scaling and chlorhexidine gluconate mouth wash) in the management of dental calculus.
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Efficacy of Vyoshadi Guggulu and Shadushana Churna in the management of subclinical hypothyroidism: An open labelled randomized comparative pilot clinical trial p. 181
Vidhya Bharti Sharma, Bharatkumar Chhaganbhai Padhar, Hari Mohan Lal Meena, Sandeep K Mathur
DOI:10.4103/ayu.ayu_359_20  
Background: Subclinical hypothyroidism (SCH) is defined as a mildly reduced function of the thyroid gland having elevated serum thyroid-stimulating hormone (TSH) level and normal concentrations of free tri-iodothyronine (FT3), free tetra-iodothyronine (FT4), T3 and T4. It occurs due to “Agnimandya” (low metabolic activity) at the systemic and cellular level. Vyoshadi Guggulu and Shadushana Churna having its effect on Agni (a root cause of SCH) are expected to prevent overt hypothyroidism and revert subclinical stage to euthyroid. Aim: This study was planned to evaluate and compare the efficacy of Vyoshadi Guggulu and Shadushana Churna in the management of Dhatvagnimandya with special reference to sub-clinical hypothyroidism (SCH). Materials and methods: Patients having serum TSH levels between 5 and 10 mlU/L and normal T3 and T4 values were diagnosed as SCH. A total of 30 patients were registered and randomly divided into two groups. In group A, patients were treated with Vyoshadi Guggulu (6 g), while in group B with Shadushana Churna (3 g) twice a day after lunch and dinner for 60 days. The assessment was done through changes in baseline and after treatment values of serum TSH level. Outcomes of the trial were analyzed using SigmaStat 4.0 version (trial) software. Student's paired t-test was used for within-group assessment, while unpaired t-test was used for intergroup comparison of the normally distributed parametric data. Observations and Results: Ten patients in group A and 11 in group B could complete the course of treatment. The findings revealed that therapy in group A and B showed decrease of 16.61% (P = 0.0494) and 26.29% (P = 0.0140) in serum TSH, respectively, 1.80% (P = 0.025) and 1.36% (P = 0.019) decrease in body mass index (BMI), respectively. The decrease in TSH and BMI was statistically significant in each group. In comparison, the decrease in serum TSH (P = 0.384) and BMI (P = 0.677) was statistically insignificant. Conclusions: Vyoshadi Guggulu and Shadushana Churna are statistically equally effective to reduce serum TSH and BMI in the management of SCH.
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Efficacy and safety of Guduchighana Vati in asymptomatic and mild-to-moderate cases of coronavirus disease-19: A randomized controlled pilot study p. 188
Umesh Shukla, Nitin Ujjaliya, Pankaj Gupta, Vivek Khare, Babita Yadav, Amit Kumar Rai, Hetalben Amin, Rakesh Rana, Arunabh Tripathi, Shruti Khanduri, Bhagwan Sahay Sharma, Bhogavalli Chandrasekhararao, Narayanam Srikanth, Kartar Singh Dhiman
DOI:10.4103/ayu.ayu_11_21  
Background: Currently, there is no approved treatment for the management of coronavirus disease (COVID-19). Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19. Aim: To determine the clinical efficacy and safety of an Ayurveda intervention (Guduchighana Vati) in asymptomatic and mild-to-moderate cases of COVID-19. Materials and methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighana Vati 500 mg twice daily for 10 days was administered in the study group and Hydroxychloroquine for 5 days in the control group. Paracetamol, Vitamin C, Multivitamin, and Zinc were also provided in the control group. The main outcome measures were to negative real-time reverse transcription–polymerase chain reaction (RT-PCR) assay for COVID-19, proportion of participants with negative RT-PCR for COVID-19 at 5th and 10th day, proportion of participants with clinical recovery, improvement in laboratory parameters, and incidence of adverse drug reaction/adverse event (ADR/AE). The results of RT-PCR and clinical recovery were compared between groups using Chi-square test. The data related to laboratory parameters were compared within group using paired sample t-test/Wilcoxon signed-rank test and between groups using independent sample t-test/Mann–Whitney test. Results: The proportion of participants with negative RT-PCR for COVID-19 in the Guduchighana Vati group (93.3%) was better as compared to the control group (66.6%) till 10th day of the study period. Though, the results are statistically not significant (P = 0.068). All the symptomatic patients in the Guduchighana Vati group clinically recovered whereas one patient remained symptomatic in the control group on the 5th day. No symptoms of COVID-19 were observed at 10th day in both the groups. No ADR/serious adverse event were observed during the study period in either of the groups. Conclusion: In this study on asymptomatic and mild to moderate cases of COVID-19, Guduchighana Vati showed numerically better proportion of participants with negative RT-PCR assay for COVID-19 and reduced time to clinical improvement which requires confirmation through studies with larger sample size. Although, the study outcomes are statistically not significant which may be due to small sample size.
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ORIGINAL ARTICLES - PHARMACEUTICAL STUDIES Top

Comparative pharmaceutico-analytical study of Rasamanikya prepared by two different Shodhana media of Haratala (orpiment) p. 197
Dipali Parekh, Sarika Makwana, Prashant Bedarkar, Biswajyoti Patgiri
DOI:10.4103/ayu.AYU_261_19  
Introduction: Foremost, Rasamanikya is described in Rasendra Chintamani by Acharya Dhundhuknath. It is a formulation that is prepared from the arsenical drug, i.e., orpiment (Haratala). Haratala is classified under Uparasa Varga in Rasa classics and is also included under Schedule E1 in D and C act 1940. In classics, there are so many media mentioned for purification process (Shodhana) of orpiment. In the present study, Kushmanda Swarasa (juice of Benincasa hispida [Thunb.] Cogn) and Churnodaka (lime water) are adopted as the purification media for orpiment. Aim: The aim of this study was to standardize the pharmaceutical procedure of Rasamanikya and develop a comparative analytical profile of both the formulation, i.e., Rasamanikya prepared by Kushmanda Swarasa and Churnodaka Shodhita Haratala. Materials and methods: The study was carried out in two stages as follows: Shodhana of Haratala and preparation of Rasamanikya by Kupipakwa method. Both the samples of Rasamanikya were analyzed for organoleptic and physicochemical parameters. The samples of final products were also analyzed through sophisticated analytical parameters, i.e., X-ray diffraction (XRD), Inductively coupled plasma-atomic emission spectroscopy (ICP-AES), CHNS and O, Field emission gun-scanning electron microscopy (FEG-SEM), Fourier transform infrared spectroscopy (FTIR) and Thermo-gravimetric analysis (TGA). Results: Average 2 h duration was required for the preparation of Rasamanikya formulation from 600 g of purified orpiment. In XRD analysis, both samples have different diffraction patterns. In ICP-AES analysis, both samples have the same percentage of arsenic. More percentage loss was noted in the TGA of Rasamanikya prepared with Churnodaka Shodhita Haratala than that of Kushmanda Swarasa Shodhita Haratala. Conclusion: Rasamanikya prepared by two different media of Shodhita Haratala did not found to have a substantial difference in pharmaceutical procedure. However, there was a considerable difference in the analytical study. Kupipakwa procedure can be used for large-scale preparation.
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