Introduction: Cognitive deficit denotes the condition characterized by impairment in the cognitive and intellectual functions. In children, it is usually detected in early schooling, wherein the children lag in processing of information including thinking, memory, perception, motivation, skilled movements and language.
Aim: The present study was conducted to evaluate the efficacy of Kalyanaka Ghrita in the management of cognitive deficit in children.
Materials and methods: A prospective, open-label study was carried out in 40 participants clinically diagnosed as cognitive deficit by administering Kalyanaka Ghrita (6 g) twice daily after food along with lukewarm water for a period of 90 days. The parameters used to assess intelligence quotient (IQ) included Binet Kamat test (BKT), and modified mini-mental status examination (MMMSE). The participants were assessed periodically at baseline (zero day), on 30th, 60th, and 90th day. Parental perception was obtained at the end of the trial. Paired sample t test was used to compare mean change in values from baseline score to the 90th day score.
Results: On comparison of the baseline scores with that at the end of the 90th day showed a statistically significant improvement in BKT and MMMSE scores (p < 0.001). No significant changes were observed in laboratory parameters.
Conclusion: Based on the results obtained at the end of the study, it can be interpreted that Kalyanaka Ghrita is safe and effective in children with cognitive deficit.
How to cite this article:
Das D, Sharma BS, Mitra A, Mahajon B. Clinical Efficacy and Safety of Brihat Gangadhara Churna in the Management of Irritable Bowel Syndrome: A Prospective Open-label Study. J Res Ayurvedic Sci 2019; 3 (3):92-99.
Background: Irritable bowel syndrome (IBS) is one of the most common gastrointestinal disorders and has been confounding physicians with its multifaceted etiology and varying presentations since long. Ayurveda associates this condition with the structural or functional impairment of the organ Grahani, secondary to impairment of Agni and imbalance of Dosha in the gastrointestinal tract. Brihat Gangadhara Churna is a drug of repute preferred by physicians of Ayurveda for managing the morbidities of Agni and Vata in Koshtha.
Objectives: To evaluate the clinical safety and efficacy of Brihat Gangadhara Churna in the management of IBS.
Materials and methods: A prospective open-label interventional single-arm study was carried out in peripheral Institute of Central Council for Research in Ayurvedic Sciences (CCRAS). A total of 90 subjects fulfilling the inclusion and exclusion criteria were recruited in the trial, of which 85 subjects completed the trial. Brihat Gangadhara Churna, in the dose of 3 g twice a day orally after food with honey as Anupana for 12 weeks was given as intervention. Follow-up was done for a period of another 2 weeks without any medication. Assessment parameters including IBS severity score, World Health Organization-Quality of Life Brief Version of the Instrument (WHO-QOL BREF) along with Ayurvedic assessment parameters were assessed every 14 days during 12 weeks of intervention as well as at the end of follow-up period, i.e., 14th week. Paired sample t test was used to compare mean change in the parameters from baseline to 84th day. A value of <0.05 was considered significant.
Results: At the end of treatment period of 84 days as compared with baseline data, significant (p < 0.001) improvement in IBS severity score and all the four domains of WHO-QOL BREF was observed.
Conclusion:Brihat Gangadhara Churna in the above-mentioned dose was found effective and absolutely safe in the management of IBS.
KM Pratap Shankar,
Introduction: Fistula in ano is considered to be complicated and vicious due to its nature of recurrences and exacerbations. Ayurveda includes this disease under the list of AstaMahagada (eight serious diseases that are difficult to treat by nature itself) due to this attribute. Ayurvedic literature offers various effective and safe management strategies for fistula in ano. Several works have been conducted to prove the efficacy and effectiveness of various treatment modalities mentioned in Ayurvedic texts. Kshara sutra, Kshara karma, Agnikarma, and Ksharavarti are a few to name in this list. A lacuna exists in not analyzing or compiling these works. Hence, the purpose of this systematic review is to generate evidence for efficacy, effectiveness, and safety profile of Ayurvedic interventions in the management of fistula in ano.
Materials and methods: Electronic search from various online databases and clinical trial registers will be done. Manual search for gray literatures will be done from various colleges and universities. There will be no language restrictions. Three authors independently will screen all citations and abstracts to identify potentially eligible trials. Based on the inclusion criteria, full articles will be evaluated and disagreements will be discussed among the three authors. Data extraction from the included studies will be done by the three reviewers independently with extraction forms containing methods, participants, interventions, comparators/controls, and outcomes. Each of the included trials will be assessed for risk of bias. Primary data analysis will be done for both qualitative and quantitative data. Heterogeneity among trials will be assessed by inspecting forest plots. If heterogeneity is detected, and it is still considered clinically meaningful to combine studies, a random-effects model will be used. Meta-analysis will be done for pooled estimates and others would be presented as narrative synthesis and shall be represented in tabular and graphical forms.
Dissemination: The systematic review will be published in a peer-reviewed journal. It will also be disseminated electronically and in print. The review may guide healthcare practices and policy framing regarding the treatment of fistula in ano with Ayurvedic interventions.
Study registration: PROSPERO registration no. CRD42019131911.
Pallavi S Mundada,
T Saketh Ram,
Manohar S Gundeti
Background: Psoriasis produces significant adverse effects on the psychological and social aspects of the patient, mainly because of its visibility. World Health Organization\'s (WHO) recent Global Report on Psoriasis states that there are many unmet research gaps in psoriasis with respect to treatment and ways to improve healthcare services. Clinical Research on psoriasis should focus on options that can be applicable globally, on a large-scale. Plenty of studies individually proving efficacy of various Ayurvedic treatment modalities in subjective and objective improvement of psoriasis are published. Systematic reviews of complementary and alternative medicine (CAM) on psoriasis are available, but these studies do not include Ayurvedic interventions.
Aim: Thorough review of published data of Ayurvedic interventions in the management of psoriasis to provide more precise estimates of safety and effectiveness of Ayurvedic interventions for psoriasis.
Objective: Outlining the protocol to conduct a Systematic Review of published studies examining the effects of Ayurvedic interventions on psoriasis.
Materials and methods: The preferred reporting items for systematic review and meta-analysis (PRISMA) protocols guidelines, The Cochrane Handbook for Systematic Reviews of Interventions, the consolidated standards of reporting trials guidelines, guidance on the conduct of narrative synthesis in systematic reviews provided the design to conduct and report the protocol, structure research question and search term selection and the data extraction form; though some adaptations may be made with regard to search terms, data synthesis, and evaluating the risk of bias.
Trial registration number: PROSPERO 2018 CRD42018097298.
Dissemination: The SR will be published in a peer-reviewed journal. The review will be updated to inform and guide healthcare practice and policy.
How to cite this article:
Dubey N, E, Das JR, Bora GK, Rao BC. Efficacy and Safety of Ayurveda Interventions for Hypothyroidism in 18–60 Years’ Age-group: A Systematic Review Protocol. J Res Ayurvedic Sci 2019; 3 (3):112-116.
Introduction: Ayurvedic interventions have been in practice for treatment of thyroid-related disorders alone or in combination with complementary medicine. No systematic review has been conducted for assessing the efficacy and safety of Ayurvedic intervention in hypothyroidism. Present study aimed to provide quality evidence to assess for the efficacy and safety of Ayurveda interventions for hypothyroidism in the 18–60 years’ age-group.
Materials and methods: For collection of data, all research article based on randomized controlled trials, multiple-arm clinical trials, nonrandomized clinical trial, quasi-randomized controlled trials having intervention period of at least 12 weeks’ duration will be considered and searched from inception to September 2019 in several databases. Primary outcome will include response to treatment (improvement in subjective criteria of assessment, i.e., hypothyroidism-related symptoms), effect on values of laboratory measures related to thyroid gland functioning like tri-iodothyronine (T3), tetra-iodothyronine (T4), and thyroid-stimulating hormone (TSH) and serious adverse events. Secondary outcome will include measurement of health-related quality of life. Data extraction will be done independently by three reviewers in a predefined format. A narrative synthesis will be conducted for all included study. If extracted data will be eligible for meta-analysis, a meta-analysis will be conducted.
Ethics and dissemination: This review does not require formal ethical assessment and approval, as no confidential participant data will be included. Findings will be disseminated widely through publication, conference, and symposia.
Study registration no: PROSPERO 2019 CRD42019144799
How to cite this article:
Bhavya B, Naik R, Shubhashree M. A Systematic Review Protocol Evaluating the Efficacy and Safety of Ayurvedic Interventions for Glaucoma. J Res Ayurvedic Sci 2019; 3 (3):117-120.
Introduction: The features of glaucoma have similarities with those of Adhimantha as mentioned in Ayurveda, where it exhibits features based on the Doshas involved. The aim of this study is to conduct systematic review of published studies in view of safety and efficacy of Ayurvedic interventions in the management of glaucoma and to run meta-analysis of the published clinical data if sufficient homogeneous studies are available.
Materials and methods: This systematic review process would include review of randomized controlled trials (RCTs), quasi-experimental designs, multiple arms clinical trials and observational studies (case series and case control) on the management of glaucoma or Adhimantha through Ayurvedic interventions. Interventions and procedures administered from a minimum of 7 days to maximum of 6 months will be included. Electronic databases search through Ayurvedic research databases and medical journal databases such as MEDLINE, Web of Science, Cochrane register, Scopus, EMBASE, directories of open access journals and hand searching will be done using predefined search terms to identify relevant studies which would include studies done between January 1990 and January 2020. The study selection, data extraction, analysis, and synthesis of results will be done by three researchers. Study selection will follow the symptomatology of Adhimantha/glaucoma as explained in different classical texts of Ayurveda, and the quality of studies will be assessed by the Cochrane risk of bias assessment for RCT and non-RCTs. The heterogeneity of reviewed studies will be evaluated by examining forest plots, and meta-analysis will be planned by using quantitative synthesis if they are sufficiently homogeneous.
Ethics approval: Formal ethical approval is not necessary as the primary data of patients will not be collected. The final results of the review will be disseminated through a peer-reviewed publication.
PROSPERO registration number: PROSPERO 2019: CRD42019133911.
How to cite this article:
Talekar M, Goel S, Sharma L, Rao BC. Efficacy and Safety of Ayurvedic Interventions in Female Infertility: Protocol for Systematic Review. J Res Ayurvedic Sci 2019; 3 (3):121-124.
Introduction: The purpose of this systematic review is to investigate the efficacy and safety of Ayurveda interventions for female infertility through analyzing trial data.
Materials and methods: A systematic review of randomized controlled trials (RCTs), non-RCT (NRCT), randomized/nonrandomized placebo control trials, quasi-RCTs (QRCTs), controlled clinical trials (CCTs), parallel arm comparative trials, and multiple arms clinical trials would be conducted through electronic search of the following databases: PubMed, AYUSH Research Portal, Google Scholar, the Cochrane Library [the Cochrane database of systematic reviews, digital helpline for ayurveda research articles (DHARA), the Cochrane central register of controlled trials (CENTRAL), and the Cochrane methodology register] without any restriction of the publication year. Hand search, snowballing of studies will also be performed to fetch the complete literature. The selection of the studies, data abstraction, and validations will be performed independently by two teams of reviewers. Conclusion will be derived with the consensus of complete review team. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. If sufficient data are available, a meta-analysis will be conducted.
Discussion: This review will help to develop strategies for the management of female infertility using Ayurveda intervention with support from evidence compiled from various clinical studies in this area.
Dissemination: The systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. The review will be updated to inform and guide healthcare practice and policy.
Trial registration number: PROSPERO 2019 CRD42019139503.