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Dave PP, Ahmad A, Gundeti MS. A Systematic Review Protocol for Assessing Efficacy and Safety of Ayurveda Medicine in Treatment of Allergic Rhinitis. J Res Ayurvedic Sci 2019; 3 (4):125-129.
Introduction: A systematic review is planned to investigate the safety and efficacy of Ayurveda interventions for allergic rhinitis (AR) through analyzing published and unpublished clinical research.
Materials and methods: A systematic review of published clinical work or Ayurveda interventions for AR will be conducted. PubMed, AYUSH Research Portal, the Cochrane Central Register of Controlled Trials (CENTRAL), hand searches, snowballing of studies will also be performed to fetch complete available literature. Manual search includes Ayurveda postgraduate (PG) and doctor of philosophy (PhD) dissertations on the management of AR. The selection of the studies, data extraction, and synthesis will be performed independently by researchers, and a third reviewer will seek disagreements. Established guidelines for study selection, quality assessment, and narrative synthesis will be followed. Risk of bias assessment will be performed with the help of Cochrane risk-of-bias tool for randomized trials (RoB2) tool for randomized controlled trials (RCTs) and risk of bias tool to assess nonrandomized studies of interventions (ROBINS-I) tool for non-RCTs (NRCTs). Results of the study will be narratively synthesized and presented in count, percentage, and frequency. As this will be the first systematic review on this topic, outlining the protocol ensures transparency for the completed review. Patients will not be involved in any phase of the study; however, ethical approval has been received from the Institutional Ethics Committee (IEC).
Dissemination: The review is ongoing, and after completion, it will be published in a peer-reviewed journal. The study will be updated to inform and guide healthcare practice and policy.
Trial registration number: PROSPERO 2018 CRD42018107035.
Background: Hemiplegia is the paralysis/weakness of either side of the body with varying levels of loss of function. Stroke is one among the main causes of hemiplegia. According to Ayurveda, the symptomatic presentation of Pakshaghata resembles hemiplegia. Although different types of time-tested treatment protocols are being followed as per the disease severity or stage, many a time, a common treatment strategy, reliable data regarding a standardized treatment protocol, the cost-effectiveness, or adverse effects of the various treatment protocols are lacking. Hence, a systematic review is planned in this regard. This article comprehensively details the protocol adopted for the planned systematic review.
Objectives: The manuscript reports the study protocol of a proposed systematic review with the prime objective of analyzing the published clinical data in view of safety and effectiveness of Ayurvedic treatment protocols in hemiplegia vis-à-vis Pakshaghata, qualitative review, and meta-analysis of the same.
Materials and methods: The study shall be carried out by screening the published data and the gray literature available from famous search engines, namely, PubMed, Cochrane Library, AYUSH Research Portal, DHARA, Google Scholar, web page—Ancient Science of Life, Online clinical trials registers, Shodhganga@INFLIBNET. Papers on Ayurvedic management of hemiplegia/Pakshaghata will be screened for data analysis. Full articles of potentially eligible trials shall be obtained and independently evaluated for inclusion in the review based on the types of participants (inclusion criteria). Data extraction forms for individual study shall be prepared, which include methods, participant characteristics, interventions, and outcomes. Data extracted shall be systematically analyzed and presented using appropriate software.
Discussion: The study outcome shall be disseminated in public domain. The data will reveal the benefits and adverse effects of Ayurvedic treatment in hemiplegia. This may help the stakeholders for drug/therapy selection, dose fixation, and framing future research.
Systematic review registration: PROSPERO Reg. no: CRD42019131887
Hemant Kumar Gupta
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Thejaswini C, Ramana G, Sahoo S, Gupta HK. Evaluation of Efficacy and Safety of Ayurvedic Interventions in Anxiety Disorder: Protocol for Systematic Review. J Res Ayurvedic Sci 2019; 3 (4):135-139.
Introduction: Anxiety disorder is one of the psychosomatic disorders characterized by persistent and irrational fear, anxiety, or avoidance of social or performance situations. Ayurveda incorporates different types of regimen, both therapeutic and non-therapeutic, in the management of psychiatric disorders. Till date, no systematic review of the evidence has been conducted focused on the safety and efficacy of Ayurvedic interventions in anxiety disorders. The current systematic review aims to generate evidence regarding the safety and efficacy of the Ayurveda interventions in the treatment of anxiety disorders through analysis of available data on clinical trials.
Materials and methods: The relevant full papers and abstracts will be sought from electronic databases such as PubMed, the Cochrane Library, DHARA, AYUSH Research Portal, CTRI, and Google Scholar. Randomized controlled trials (RCTs), non-randomized controlled trials (NRCTs), quasi-randomized controlled trials (QRCTs), controlled clinical trials (CCTs), randomized/non-randomized placebo-controlled trials, controlled before-and-after studies (CBA), before-and-after comparisons, parallel arm comparative trials, and multiarm clinical trials will be included. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines and the methodological appraisal of the studies will be assessed by the Cochrane risk-of-bias tool as well as Jadad Scale for RCTs and risk-of-bias in non-randomized Studies tool for NRCTs. Primary outcomes will include measures related with response to the treatment and any serious adverse events. There will be no language restrictions on the data sought and searches run on research studies published from January 1980 to till date will be eligible for inclusion. The selection of the research studies, data abstraction, and validation of the studies will be performed independently; in case of disparity or other issues regarding the suitability of study for inclusion, the opinion of the third person will be sought for consensus. A meta-analysis will be conducted and effect sizes will be generated using Hedges’ g score for both fixed and random effect models, only if sufficient data are available.
Ethics and dissemination: As this will be a systematic review, which does not involve human beings, there will be no requirement for ethical approval. Findings will be disseminated widely through peer-reviewed publication and through conferences or symposia.
Trial registration number: CRD42019139230.
Introduction: A systematic review is planned to investigate the safety, efficacy, and effectiveness of Ayurvedic interventions in the management of Tamaka Shwasa/bronchial asthma through systematic analysis of published clinical researches.
Materials and methods: A systematic review of the published clinical work for Ayurvedic interventions for Tamaka Shwasa/bronchial asthma will be conducted. Electronic searches, such as, EMBASE, MEDLINE, COCHRANE and AYUSH Research Portal, DHARA, Shodhganga Databases on dissertation works, conference proceedings, print journals, and reference list of articles, will be considered in the search strategy. All studies as per inclusion criteria including study design and participants will be analyzed by two investigators individually; in case of ambiguity, it will be discussed by a senior expert (investigator). The population (P in PICO) will include diagnosed cases of bronchial asthma/Tamaka Shwasa, where intervention (I) will be Ayurveda stand alone or as add-on with conventional therapy and (C) comparator will be Ayurveda and non-Ayurveda interventions or placebo. The primary outcome (O) will be improvement evident by a decrease in dyspnea, rhonchi, number of attacks, and classical symptoms of Tamaka Shwasa. Risk of bias assessment using Robin\'s tool will be used for non-randomized clinical trials, whereas CONSORT statement will be used for quality assessment of randomized clinical trials.
Dissemination: This review is ongoing, and upon completion, the review will be published in a peer-reviewed journal. The review will be updated to inform and guide healthcare practice and policy. The results will be presented in terms of high risk, moderate or low/unclear risk in risk of bias assessment.
Trial registration number: PROSPERO 2019 CRD42019123886.
K Prameela Devi,
Mukesh B Chincholikar,
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Devi KP, Ota S, Chincholikar MB, Maheshwar T, Rao B. Clinical Evaluation of the Efficacy of Saubhagyashunthi Paka and Dashamularishta in Sutika Paricharya (Postnatal Care): Study Protocol for an Open-label, Noncontrolled Trial. J Res Ayurvedic Sci 2019; 3 (4):144-151.
Background: The postnatal period begins immediately after the separation of the placenta extending up to 6 weeks, otherwise called as the puerperium or puerperal period. The care given during this period is called as Sutika Paricharya (postnatal care) in Ayurveda. During the time of labor, the mother undergoes tremendous physical exertion and becomes extremely debilitated, physically and mentally, which leads to derangement of Dosha especially Vatadosha in the mother. These factors cause general weakness, pain in the abdomen, low back pain, loss of appetite, dysfunction of the bladder, postnatal psychosis, etc. Apart from these, the mother also suffers with Dhatukshaya (weakness of body tissue). Prevention of puerperal sepsis, management of other complications, proper involution of genital organs, and proper lactation need to be well managed during the puerperal period. Based on the information available in the Ayurvedic texts regarding the management during Sutika Kala (postnatal phase), this study has been designed to assess the clinical efficacy of two Ayurvedic classical formulations, viz., Saubhagyashunthi Paka and Dashamularishta for the effective management of the puerperal phase.
Materials and methods: A single-center, noncontrolled, open-label clinical trial as a means of assessing the therapeutic efficacy of Saubhagyashunthi Paka and Dashamularishta will be conducted. A total of 40 participants will be recruited for the study. The study period is 12 months, during which all the participants will be given the trial drugs for a duration of 8 weeks along with the standard care as recommended by established guidelines.
Outcome measures: The primary outcome measure is to restore the strength of the mother and minimize the complications and establishment of sufficient lactation. The secondary outcomes are improvement in the quality of life and clinical safety of the trial drugs. Statistical evaluation would be done at the end of the trial period to compare the changes in the assessment parameters from the baseline.
Discussion: The study will generate the preliminary evidence of the efficacy of Saubhagyashunthi Paka and Dashamularishta in Sutika Paricharya (w.s.r. to postnatal care), which will validate the Ayurvedic therapeutic approach for the management of Sutika Paricharya and will also help to design a randomized controlled trial.
Trial registration: Clinical Trials Registry—India [CTRI/2020/01/022935]
Vitiligo is the most common pigmentation disorder and is described as Shwitra/Kilasa in Ayurveda due to its characteristic appearance. It is caused by the imbalance of all three Doshas (Vata, Pitta, Kapha) vitiating Rakta, Mamsa, and Medadhatus. Shwitra is harmless but a very serious cosmetic problem which affects the emotional, psychological, and social well-being of the affected person. An 11-year-old male diagnosed with vitiligo vulgaris (Shwitra), presented with complaints of increasing area and number of depigmented patches of skin which was managed by following Ayurveda principles. A treatment protocol was designed based on the signs and symptoms observed in this patient. The protocol includes Shodhana (Dipana-Pachana, Snehapana followed by Virechana), followed by Shamana treatment with a combination of powdered herbal drugs, viz., Manjishtha (Rubia cordifolia), Bakuchi (Psoralea corylifolia), Lodhra (Symplocos racemose), and Nagkeshara (Mesua ferrea) powder and Arogyavardhini Vati orally along with Bakuchi Taila (oil) for local application. The treatment protocol was found to be effective in the reversal of depigmented patches to repigmentation, which may be adopted in future cases, using different combinations of drugs based upon the different Ayurvedic parameters to obtain even better results.
Amit K Dixit,
Sudesh N Gaidhani,
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Dixit AK, Sarkar M, Puia L, Bora M, Gaidhani SN, Hazra J. Efficacy of Ayurvedic Interventions in Hypothyroidism: A Comprehensive Review. J Res Ayurvedic Sci 2019; 3 (4):157-163.
Thyroid disorders have been one among the most challenging and most common endocrine disorders that we confront worldwide. Major thyroid disorders include hypothyroidism, hyperthyroidism, goiter/iodine deficiency, Hashimoto\'s thyroiditis, and thyroid cancer. Among these, hypothyroidism is arguably the most challenging as its multifarious clinical presentation often goes unnoticed. Hypothyroidism can be attributed to the deficiency of thyroid hormones, triiodothyronine (T3) and thyroxine (T4), in the body. Mild or subclinical hypothyroidism refers to the condition where peripheral thyroid hormone levels are within normal range, but serum thyroid-stimulating hormone (TSH) levels are mildly elevated. Data to date are scarce that include direct experimental, pharmacological, or preclinical types of evidence of treating hypothyroidism with Ayurvedic and herbal drugs. The scope of this manuscript covers the utility of conventional Ayurveda or herbal drugs in ameliorating the pathophysiological symptoms of hypothyroidism. Treatment strategies have been evolving since the early and mid-twentieth century, starting from using the whole thyroid extract to the modern-day thyroxine monotherapy by L-thyroxine. Despite these advances, there remains a considerably large population who endure the symptoms of hypothyroidism. Various assortments of formulations are available for such conditions in Ayurveda system of medicine since the very early days of civilization. In Ayurveda, though there are not any direct reference of thyroid, Galaganda and Gandamala, which possess symptomatic similarities with thyroid disorders, have been mentioned frequently in the texts. With the present data available, it is concluded that natural resources around can be utilized for the prevention and amelioration of hypothyroidism in mammals.