Journal of Research in Ayurvedic Sciences最新文献

{"title":"Efficacy of Ayurveda intervention “Ayuraksha Kit” on COVID-19 incidence and outcomes: A prospective cluster randomized community-based study in India","authors":"Sunita Mata, Kishor Gavali, S. Ota, R. Singhal, Arunabh Tripathi, Seemalata Jain, D. Makhija, Parvathy Nair, P. Nair, P. Aswani, S. Otta, K. Ratha, Dipsunder Sahu, D. Das, H. Singh, Avvaru Sai Prasad, A. Shrivastava, Pallavi Kamble, Laxman W. Bhurke, Saylee Deshmukh, S. Vedi, Swati Sharma, Deepak Sharma, Neelam Singh, Savita Gopod, Chagamreddy Krishna, G. Reddy, S. Sangvikar, Vanmala B Wakode, Emy Surendram, T. Sinimol, K. Kumar, V. Tewari, P. Bharti, G. Bora, Shri Prakash, Rahul D. Ghuse, G. Kumar, Poonam Mohod, V. Negi, C. Antony, S. Paikrao, Anil D. Avhad, Rinky Thakur, M. Shubhashree, R. Naik, S. Asha, K. Devi, Rakesh Rana, B. Sharma, S. Khanduri, Vinod Shahi, Narayanam Srikanth","doi":"10.4103/jras.jras_127_22","DOIUrl":"https://doi.org/10.4103/jras.jras_127_22","url":null,"abstract":"BACKGROUND: Ayurvedic medicines have been used as preventative care and for managing COVID-19 in India from the early days of the pandemic. This study was conducted to evaluate the effectiveness of the Ayuraksha kit (ARK), a combination of four extensively used Ayurvedic interventions, as prophylactic care against COVID-19. OBJECTIVE: The primary objective was to observe the non-occurrence of COVID-19, and the secondary objective was to observe the changes in the general well-being and manifestation of COVID-19-like symptoms in the participants. MATERIAL AND METHODS: This was a prospective, open-label, multi-center, cluster randomized community-based study conducted from October 2020-March 2021 in India. A total of 153047 participants of either sex, aged 18 - 70 years, living in Scheduled Caste dominated areas of 18 identified states in India, were enrolled. The clusters from where at least one COVID-19 case was identified were randomized and allocated into two groups. In Group-I (n = 1,34,364), Ayuraksha Kit, which contains (Chyawanprash 6 gm once daily; Ayush Kwatha 75 ml once daily; Samshamani Vati 500 mg twice daily and Anu Taila one drop in each nostril twice daily) was administered for one month along with the standard preventive measures for COVID-19. In Group II (n = 18,683), only standard preventive measures for COVID-19 as per the existing guidelines were followed. RESULT: The proportion of participants who did not report having COVID-19 were significantly higher (98.9%)in the ARK group than in the control group (98.1%) after adjusting the history of contact with COVID-19 positive subject/contact with a person having COVID-19 symptoms. The proportion of participants with COVID-19 symptoms was slightly more in the control group. Among the COVID-19-positive cases, symptomatic cases were more in the ARK group, but the incidence of hospitalization (9.8%) was much lesser than that of the control group (12.5%). Improvements in general well-being (appetite, bowel, and sleep quality) were better in the ARK group than in the control group. The medicines in the ARK were well tolerated. CONCLUSIONS: ARK may be used for general well-being and as prophylaxis for preventing COVID-19 infection.","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"46 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132366302","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An open-label, randomized, exploratory study to evaluate the effect of internal oleation and therapeutic purgation on lipid profile in patients with skin diseases","authors":"D. Makhija, V. Deep, S. Krishna rao, Aaditya Shah, R. Patil, Sakshi Sharma, Bharti Gupta, B. Sharma, S. Khanduri, Rakesh Rana, R. Singhal, Narayanam Srikanth","doi":"10.4103/jras.jras_83_21","DOIUrl":"https://doi.org/10.4103/jras.jras_83_21","url":null,"abstract":"BACKGROUND: In Ayurveda therapeutic principles, internal oleation (IO) is essential before Virechana (purgation therapy). The IO is mainly done using plain or specific medicated ghee according to the disease condition. Virechana is a primarily utilized therapy for treating skin diseases. This pilot study evaluates and compares the effect of IO by using cow ghee (CG) and Mahatiktaka Ghrita (MTG), followed by Virechana, on lipid profiles in individuals suffering from skin diseases but having normal serum lipid levels. MATERIALS AND METHODS: A total of 60 patients were enrolled in this open-label, randomized, multicenter exploratory study and equally divided into two groups. The Ayurveda interventions for IO in groups I and II were CG and MTG, respectively. In both groups, after the completion of 3 to 7 days of IO, Virechana, by using Avipattikar churna (AVC), was done. The effect of the interventions was assessed after completion of IO, and the next day after Virechana, by laboratory investigations such as lipid profile, liver function (LFT) and renal function tests (RFT). Comparative statistical analysis of observations between the baseline, after oleation, and after Virechana was done using statistical software SPSS Version 15.0. RESULTS: A total of 55 participants (27 in group I and 28 in group II) completed the study. After IO and Virechana, changes were reported in the lipid profile, LFT and RFT. All the observed changes are within the standard normal range of the respective laboratory parameters. CONCLUSIONS: To some extent, the IO with CG, MTG, and Virechana therapy can result in clinical changes in LDL, LFT, and RFT within normal limits. As per the Ayurveda concepts, Sansarjana Karma is a must after Virechana for complete recovery. Therefore, further research on changes in lipid profile after IO and Virechana following Sansarjana Karma is required.","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"64 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131730419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prophylactic effect of Ayurveda interventions in prevention of COVID 19 in selected containment zones of Delhi: A prospective open label community based study","authors":"B. Rao, B. Yadav, M. Sharma, Sophia Jameela, Rakesh Rana, R. Singhal, B. Sharma, S. Khanduri, D. Makhija, Bharti Gupta, Adarsh Kumar, S. N., K. Dhiman, Field Investigators","doi":"10.4103/jras.jras_124_22","DOIUrl":"https://doi.org/10.4103/jras.jras_124_22","url":null,"abstract":"BACKGROUND: The exponential rise of cases and associated morbidity and mortality has managed to make COVID-19 a serious threat. Minimising the transmission of disease by prevention and control strategy forms the core-pillar of response. Ayurveda with its holistic approach can potentially promote disease prophylaxis both at the individual as well as community levels. This clinical study was executed in a community set-up to explore the potential of Ayurvedic interventions in COVID-19 prophylaxis. MATERIALS AND METHODS: The study was conducted as an open label community based study in six selected containment zones of Delhi on 9200 individuals with an objective to record the incidence of COVID-19 in these areas. The selected Ayurvedic Interventions (Ashwagandha, Maha Sudarshan Ghan Vati, Samshamani Vati) were distributed in the dose of two tablets of 250 mg each twice daily after food with lukewarm water for a period of one month. Onset of any COVID-19 related clinical symptoms, patient satisfaction in general health parameters and incidence of ADR/AE were taken as outcome measures. RESULTS: 9010 participants were recruited with mean age of 37.9 years. A total of 12 participants (0.17%) were reported positive during the intervention period, among 279 who underwent testing (because of contact tracing or symptoms). Participants who were devoid of any symptoms throughout the trial period were 98.8%. Statistically significant improvement was observed in parameters of general well-being at the end of study period. CONCLUSION: Ayurveda interventions demonstrated potential as a safe prophylactic measure against COVID 19 with comparatively good compliance and minimal adverse effects.","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127907891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Ayurveda formulations, Panchamrit Lauha Guggulu and Panchguna Taila in the management of Cervical Spondylosis (Greevagraha): A prospective single-arm clinical trial","authors":"V. Negi, Renu Singh, Anubha Chandla, O. Sharma, SurinderKumar Sharma, Rakesh Rana, R. Singhal, B. Sharma, S. Khanduri, Adarsh Kumar, Narayanam Srikanth","doi":"10.4103/jras.jras_102_21","DOIUrl":"https://doi.org/10.4103/jras.jras_102_21","url":null,"abstract":"BACKGROUND: Cervical spondylosis (CS) is a degenerative disease of intervertebral discs with the formation of osteophytes in the cervical vertebrae. Based on the similarity in symptoms such as intermittent neck and shoulder pain, pain and stiffness radiating to the shoulder or occipital region, restricted neck movements, numbness, and weakness in arms, hands, and fingers, CS can be correlated with Greevagraha—a disease of the neck narrated in Ayurveda. In Ayurveda, the formulations Panchamrit Lauha Guggulu (PLG) and Panchguna Taila (PGT) have been narrated in treating musculoskeletal disorders. OBJECTIVE: The objective of the study was to evaluate the clinical efficacy and safety of PLG and PGT in the management of CS. MATERIALS AND METHODS: It was a prospective, single-arm, open-label clinical study. A total of 63 patients aged 30–60 years diagnosed with CS have been treated with PLG 250 mg twice a day orally with lukewarm water after food and an external application of PGT at the neck region. The total duration of the treatment was 12 weeks, with a follow-up every 2 weeks and a post treatment follow-up after 2 weeks of the treatment. The outcome measures include change in Northwick Park Neck Pain Questionnaire (NPNPQ) score, Visual Analog Scale (VAS) score for cardinal features, SF-36 (research and development [RAND]) Health Survey Score, and incidence of adverse events (if any). RESULTS: At baseline, X-ray findings of all participants (100%) had degenerative changes at different levels of cervical vertebrae; however, posttreatment X-ray findings (on the 84th day of study) showed normal X-ray findings in eight participants (5.04%). A significant reduction in the total VAS score (P < 0.001) was observed on day 84 and day 98. The mean NPNPQ score reduced significantly (P < 0.0001), and a highly significant change was observed in the SF-36 Health Survey Score (P < 0.0001). No adverse events were reported during the study period. CONCLUSIONS: PLG and PGT have shown promising outcomes in managing CS and were also safe. However, randomized control trials with adequate sample size, standard care as control, and a longer follow-up may be planned to establish the findings of this preliminary study.","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124033091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of Ayush AGT gel-based cream in superficial external wounds: Study protocol of an open-label multicenter interventional single-arm trial","authors":"A. Rai, S. Khanduri, Sumeet Goel, Maheshwar Thugutla, H. Panigrahi, Avvaru Sai Prasad, Anil D. Avhad, R. Singhal, Rakesh Rana, B. Chandrasekhararao, Narayanam Srikanth","doi":"10.4103/jras.jras_112_22","DOIUrl":"https://doi.org/10.4103/jras.jras_112_22","url":null,"abstract":"BACKGROUND: Traditional medicine has been extensively used to manage skin wounds since ancient times. Central Council for Research in Ayurvedic Sciences has developed a coded herbal formulation, Ayush AGT gel-based cream, through a systematic drug development process for managing superficial skin wounds. OBJECTIVE: This clinical study is designed to determine the clinical efficacy and safety of Ayush AGT gel-based cream in healing superficial external wounds. MATERIALS AND METHODS: This open-label, multicenter, prospective, interventional single-arm trial is being conducted at three peripheral institutes of the Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India viz. Central Ayurveda Research Institute, New Delhi, and Regional Ayurveda Research Institutes at Ahmedabad and Vijayawada, India. A total of 30 participants will be enrolled in the study from each of the three study sites. Patients of any sex aged 18–60 years with superficial external wounds requiring dressing and solitary wounds not less than 2.5 cm in diameter will be considered for enrollment in the study. The enrolled participants will be managed by the topical application of Ayush AGT gel-based cream on the wound bed once daily, followed by bandaging with the sterile material for four weeks. The outcome measures are time to complete re-epithelialization of the wound, incidence of wound infection, pain during the change of dressing (assessed through visual analog scale), incidence of blistering, and adverse events. DISCUSSION: Ayurveda interventions have been found effective in wound healing in routine clinical practice as well as in published experimental and clinical studies. Ethno-medicine practices also utilize different medicinal plants to manage skin wounds. Several patents on herbal interventions for wound healing have also been granted. However, clinical research to explore the standard wound management for superficial external wounds is not common. So, it is expected that the outcomes of this study will provide a significant lead in the search for safe and effective management options for skin wounds.","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121976387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"\"Chikitsa Sutra\": A ready reckoner of treatment guidelines catering to rationalization of Ayurvedic ideology","authors":"Rabina Acharya","doi":"10.4103/jras.jras_167_22","DOIUrl":"https://doi.org/10.4103/jras.jras_167_22","url":null,"abstract":"","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"78 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131724185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Knowledge, attitudes, and practice of Triphala in the community: An exploratory cross-sectional survey study","authors":"V. Mali, Anupama Krishnan, P. Mali, Ketki Wagh, Sikha Lekharu, P. Gupte","doi":"10.4103/jras.jras_55_22","DOIUrl":"https://doi.org/10.4103/jras.jras_55_22","url":null,"abstract":"BACKGROUND: Codified and noncodified information about Ayurveda practices and formulations is available and transmitted as science or folk claims. Triphala, a well-researched Ayurveda formulation, lacks studies reporting community perception regarding its usage. This study explores Triphala’s knowledge, attitude, and practice in the community. MATERIALS AND METHODS: This exploratory cross-sectional study involving 806 residents of Pune, New Delhi, Guwahati, Kottakkal, and rural areas of Rajkot was undertaken to evaluate Triphala’s knowledge, attitude, and practice in the community. A pretested and structured questionnaire addressing Triphala’s knowledge, attitude, and practice was administered through Google forms or a personal interview method. Data were managed and analyzed by SPSS 20.0, and descriptive statistics were generated. RESULTS: A total of 30% of participants demonstrated good knowledge, and 42% demonstrated positive attitude. A total of 41.84% of respondents knew the ingredients of Triphala, 68% knew its use in constipation, 26% in health maintenance, and 22.2% in weight loss. Also, powdered dosage form (93.6%) is used predominantly through the oral route with lukewarm water (94.1%) as a vehicle. Around half of the respondents have previously used Triphala for various health conditions. The knowledge regarding the proportion of Triphala ingredients, and other formulations containing Triphala, was less at all sites. A good number of people (38.9%) are ready to consume Triphala for health maintenance. The rural area had a lower response rate compared with the urban but with similar response patterns for most domains. CONCLUSIONS: A substantial proportion of people in the general population knew the ingredients of Triphala, its use in various health conditions, route of administration, adjuvants, and cost-effectiveness. A good number of people showed readiness for the consumption of Triphala daily. However, the research component of Triphala has not sufficiently percolated. Hence, empowering the public on the utilization aspects and research evidence of Triphala would propagate the evidence-based practice of Ayurveda for scientific sustainability.","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"93 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133153388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic evaluation of Rasnadi Gutika and Chandrakala Lepa in Janusandhigata Vata (osteoarthritis knee): A single-arm prospective multicenter clinical study","authors":"Banamali Das, Sanjay Singh, S. Meher, Alok Kumar Srivastav, S. Ota, Rakesh Rana, Richa Singhl, B. Sharma, S. Khanduri, Adarsh Kumar, M. Rao, Narayanam Srikanth","doi":"10.4103/jras.jras_38_21","DOIUrl":"https://doi.org/10.4103/jras.jras_38_21","url":null,"abstract":"BACKGROUND: Sandhivata [osteoarthritis (OA)] is one of the Vata Vyadhi, which causes much suffering for a prolonged period. The cause of Sandhivata in Ayurveda is attributed to improper diet, lifestyle, and old age, leading to aggravation of Vata, and is associated with slow and steady decline in tissue quality and function. The disease specific symptoms of Sandhigata vata are very similar to that of OA. Treatment in OA is targeted for reviving joint function through halting the disease pathogenesis and promotion of joint health and vitality. OBJECTIVE: The objective of this study was to assess the clinical efficacy of Rasnadi Gutika (RG) and Chandrakala Lepa (CKL) in the management of Janusandhigata Vata [osteoarthritis knee (OA knee)]. MATERIALS AND METHODS: The study was conducted at two peripheral institutes of the Central Council for Research in Ayurvedic Sciences, viz., Central Ayurveda Research Institute, Bhubaneswar, Odisha and Regional Ayurveda Research Institute, Lucknow, Uttar Pradesh. A total of 120 patients between the age of 40 and 75 years suffering from primary OA knee joint were treated with RG and CKL. The duration of the therapy was 12 weeks, and follow-up was done on the 14th, 28th, 42nd, 56th, 70th, and 84th days. RG was administered orally in the dose of 1 g twice daily with lukewarm water, and CKL 10 g was applied locally twice daily for 12 weeks. Parameters such as chief complaints of the disease, viz., joint pain on movement, joint pain at rest, restricted joint, crepitus, swollen joint, stiffness, and bony enlargement; total WOMAC score; and quality of life through WHO QOL BREF score were assessed before and after the administration of therapy. RESULTS: The WOMAC score, the key outcome measure, showed statistically significant improvement (P = 0.001) on the 84th day of follow-up. Improvement was noted in all areas, including pain, stiffness, and physical functioning. The physical health, physiological and social relationships, and environmental areas of the WHO QOL BREF score for quality of life were also significantly influenced (P = 0.0001). No adverse drug reactions or adverse events were reported during the trial period. CONCLUSION: Oral administration of RG and external application of CKL are effective for the management of OA knee. However, further clinical study with sufficient sample size may be required to revalidate this study’s findings.","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"315 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124293617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing research ecosystem in Ayurveda institutions and inculcating research culture among Ayurveda professionals—Need of the hour","authors":"B. Prasad","doi":"10.4103/jras.jras_85_22","DOIUrl":"https://doi.org/10.4103/jras.jras_85_22","url":null,"abstract":"","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"278 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121716321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Ksharasutra prepared through automated machine and manual process in fistula-in-ano: A study protocol for a double-blind, randomized controlled trial","authors":"A. Rai, B. Yadav, H. Panigrahi, R. Singhal, B. Chandrasekhararao, Rakesh Rana, Narayanam Srikanth","doi":"10.4103/jras.jras_95_22","DOIUrl":"https://doi.org/10.4103/jras.jras_95_22","url":null,"abstract":"BACKGROUND: The manufacturing process of Ksharasutra is still predominantly manual, even in the current era. It inherently leads to small-scale production and restricted availability of this effective treatment. CCRAS has developed a prototype of an automated machine to manufacture the Ksharasutra on a large scale. OBJECTIVE: This clinical study will investigate the safety and efficacy of the Ksharasutra prepared through the automated machine and compare its efficacy with the manually prepared Ksharasutra. MATERIALS AND METHODS: This study is a double-blind, randomized controlled, parallel-group trial being conducted at the Central Ayurveda Research Institute, New Delhi. A total of 100 participants will be enrolled in the study. Individuals of any sex aged 18–60 years and diagnosed with fistula-in-ano complaining of perianal discharge, pain, tenderness, itching, and induration will be enrolled in the trial. The enrolled participants will be managed by the automated machine-prepared Ksharasutra in the trial group and the manually prepared Ksharasutra in the control group. The Ksharasutra will be changed every week till the fistula tract is completely cut off. The outcome measures include the change in the quality of life (assessed through the SF-36 questionnaire), unit cutting time of the fistula tract, the proportion of participants having complete healing of the fistula tract, and the incidence of adverse events. DISCUSSION: The conventional surgical treatment of fistula-in-ano is associated with a significant recurrence rate and a high risk of impaired anal continence. Compared with conventional treatment, Ksharasutra therapy is simple, cost-effective, and associated with minor post-operative care, minimal complications, and a low recurrence rate. However, small-scale manufacturing due to manual preparation, non-uniformity of techniques involved in the manufacturing of Ksharasutra, and so on limits the availability and quality of this therapy. Awareness regarding the benefits of Ksharasutra therapy and availability of surgeons experienced in this procedure can play a significant role in improving the accessibility of this para-surgical technique. TRIAL REGISTRATION: CTRI/2021/12/038414, dated 3 Dec. 2021","PeriodicalId":394246,"journal":{"name":"Journal of Research in Ayurvedic Sciences","volume":"74 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130365553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}