Journal of Research in Ayurvedic Sciences

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2019 | January-March | Volume 3 | Issue 1

EDITORIAL

Vaidya K.S. Dhiman

Re-establishing Ayurveda Principles – The Way Forward

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:1] [Pages No:00 - 00]

PDF  |  DOI: 10.5005/jras-3-1-v  |  Open Access |  How to cite  | 

PROTOCOL

Amrish P Dedge, Tushar K Mandal, Manohar S Gundeti, Laxman W Bhurake, Shyam G Kale, Parth P Dave

A Systematic Review of the Safety and Efficacy of Ayurveda Interventions for Hepatitis: A Protocol for Systematic Review

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:5] [Pages No:1 - 5]

Keywords: Ayurveda, Hepatitis, Systematic review

PDF  |  DOI: 10.5005/jras-10064-0073  |  Open Access |  How to cite  | 

Abstract

Introduction: A systematic review is planned to investigate the safety and efficacy of Ayurveda interventions for hepatitis through analyzing published clinical research work. Materials and methods: We shall conduct a systematic review published clinical work for Ayurveda interventions for hepatitis. Electronic search of following databases will be performed: PubMed, AYUSH Research Portal, Digital Helpline for Ayurveda Research Articles (DHARA), Google Scholar, the Cochrane Library (the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Cochrane Methodology Register) without any restriction of publication year. Hand search, snowballing of studies will also be performed to fetch complete available literature. The selection of the studies, data abstraction, and validations will be performed independently by two teams of researchers. A conclusion will be derived from the consensus of the complete review team. Study selection will follow the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines and study quality will be assessed by the CONSORT checklist for randomized controlled trials (RCTs), transparent reporting of evaluations with nonrandomized designs (TREND) checklist for nonrandomized controlled trials (NRCTs), and CONSORT extension for pilot and feasibility studies for pilot studies. Risk of bias assessment will be performed with the help of the Cochrane risk-of-bias tool for randomized trials (RoB2) tool for RCTs and risk of bias in nonrandomised studies of interventions (ROBINS-I) tool for NRCTs. If sufficient and appropriate data are available, a meta-analysis will be conducted. Subgroup analysis and sensitivity analysis will be performed if found to be necessary and feasible. 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: CRD42019103115.

PROTOCOL

Amit K Rai, Harit Kumari, Azeem Ahmad, Sanjiv Kumar, Bhogavalli Chandra Sekhara Rao

Efficacy and Safety of Ayurveda Interventions for Obesity: Protocol for a Systematic Review

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:6] [Pages No:6 - 11]

Keywords: Systematic review,Ayurveda, Medoroga, Obesity, Overweight, Sthaulya

PDF  |  DOI: 10.5005/jras-10064-0067  |  Open Access |  How to cite  | 

Abstract

Background: Obesity is similar to Sthaulya or Medoroga described in Ayurvedic classical texts. Results from case studies/series and small clinical trials concluded that Ayurveda interventions have been effective in the management of obesity. This protocol aimed to do a systematic review of clinical studies related to Ayurvedic interventions in the management of obesity and further meta-analysis of eligible studies to generate the evidence regarding effectiveness and safety of Ayurvedic treatment modalities for obesity. Materials and methods: Clinical studies related to Ayurvedic interventions in the management of Sthaulya/Medoroga or overweight/obesity published in English/Hindi will be screened as per the inclusion criteria without restriction on publication date and type. Primary outcomes to be assessed will be improvement in clinical features of Sthaulya/Medoroga and change in body weight, body mass index (BMI), waist circumference, waist–hip ratio, and skin-fold thickness. Data will be extracted independently by two review authors on study characteristics (authorship, publication-related information, methodology, participants, interventions, comparators, outcomes, and results) in a prestructured format for assessment of study quality and data analysis. Two authors will independently assess the risk of bias in included studies. We will conduct meta-analyses only when the included studies will be sufficiently homogeneous in terms of design, study population characteristics, interventions, and outcome measures. If meta-analyses will not be conducive, we will summarize the results of included studies as systematic qualitative synthesis. Conclusion: The results generated from this review will be helpful in identifying the status of evidence for Ayurvedic interventions in management of obesity. It will also provide way for future research to generate stronger evidence regarding efficacy of Ayurvedic interventions in the treatment of obesity. Clinical significance: The study will be able to generate evidence for effective implementation of Ayurvedic interventions in treatment and prevention strategies for obesity. Study registration: PROSPERO 2019—CRD42019130104.

PROTOCOL

Sumeet Goel, Azeem Ahmad, Arvind Kumar, Rajeshwari Singh, Bhogavalli Chandra Sekhara Rao

Efficacy of Ayurvedic Interventions in Rheumatoid Arthritis: Protocol for Systematic Review

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:5] [Pages No:12 - 16]

Keywords: Amavata, Protocol for a systematic review and meta-analysis, Vatarakta

PDF  |  DOI: 10.5005/jras-10064-0071  |  Open Access |  How to cite  | 

Abstract

Introduction: Rheumatoid arthritis (RA) has been treated in Ayurveda, and substantial work has been done in studying the role of Ayurveda interventions in its management. A systematic review is planned to investigate the safety and efficacy of Ayurveda interventions for RA through analyzing published clinical research work. Materials and methods: This study is intended to systematically review the existing published clinical work including randomized controlled trials (RCTs), controlled clinical trials, parallel-group trials, and single-group clinical studies for Ayurveda interventions for RA. Electronic search of the following databases will be performed: PubMed, AYUSH research portal, digital helpline for Ayurveda research articles (DHARA), Google Scholar, the Cochrane Library (the Cochrane Database of systematic reviews, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Cochrane Methodology Register), Ayurveda college/Universities websites, databases for dissertation works without any restriction of publication year. Hand search and snowballing of studies will also be performed to fetch complete available literature. The selection of the studies, data abstraction, and validations will be performed independently by two teams of researchers. Conclusion will be derived with consensus of complete review team. Study selection will follow the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, and study quality will be assessed by CONSORT checklist for RCTs, Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist for nonrandomized controlled trial (NRCTs), and CONSORT extension for Pilot and feasibility studies for pilot studies. Risk of bias assessment will be performed with the help of Cochrane RoB2 tool for RCTs and Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool for NRCTs. If sufficient and appropriate data are available, a meta-analysis will be conducted. Subgroup and sensitivity analyses will be performed if found to be necessary and feasible. Ethics and dissemination: Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication. The review will be updated to inform and guide healthcare practice and policy. Trial Registration Number: International Prospective Register for Systematic Reviews (PROSPERO) number 2019 CRD42019133722.

PROTOCOL

Saylee Deshmukh, Pallavi S Mundada, Thrigulla Saketh Ram, Manohar S Gundeti

A Protocol for Systematic Review and Meta-analysis of Ayurvedic Interventions for Essential Hypertension

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:5] [Pages No:17 - 21]

Keywords: Ayurvedic intervention, Essential hypertension, Meta-analysis, Systematic review

PDF  |  DOI: 10.5005/jras-10064-0072  |  Open Access |  How to cite  | 

Abstract

Introduction: A systematic review (SR) is planned to investigate the safety, efficacy, and effectiveness of Ayurvedic interventions in the management of essential hypertension through analyzing published and unpublished clinical research. Materials and methods: A systematic review of published and unpublished clinical researches on Ayurveda interventions in the management of essential hypertension will be conducted. Electronic search will be carried out in PubMed, AYUSH Research Portal, the Cochrane Central Register of Controlled Trials (CENTRAL), and hand search, snowballing of studies will also be performed to fetch complete available literature. Manual search will be carried out for Ayurveda Post Graduate (PG) and Doctor of Philosophy (PhD) dissertations on management of essential hypertension. The selection of the studies, data extraction, and synthesis will be performed independently by researchers, and disagreements will be sought by a third reviewer. Established guidelines for study selection, quality assessment and narrative synthesis will be followed. Risk of bias assessment will be performed with help of Cochrane RoB2 tool for randomized controlled trials (RCTs) and ROBINS-I tool for non-RCTs (NRCTs). Results will be narratively synthesized and will present the same in count, percentage and frequency. As this will be the first SR 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 sought from the institutional ethics committee. Results: The review is ongoing and after completion, the review will be published in a peer-reviewed journal. The review will be updated to inform and guide healthcare practice and policy. Trial registration number: PROSPERO 2019 CRD42019123886.

PROTOCOL

Pulikunnel S Aswani, Pratibha P Nair, Girija N Sree Deepthi, Gaddam K Swamy

A Systematic Review Protocol to Assess the Effectiveness of Ayurveda Interventions in Gout

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:5] [Pages No:22 - 26]

Keywords: Ayurveda interventions, Gout, Systematic review, Vatarakta

PDF  |  DOI: 10.5005/jras-10064-0068  |  Open Access |  How to cite  | 

Abstract

Introduction: Ayurveda offers healthy, harmonious, and long life by its holistic approach. Gout is a form of arthritis caused by excess uric acid in the bloodstream. Gout may be considered as Vatarakta or Vatasonita as per Ayurveda. Even though gout is managed well with conventional medicine, there are a lot of side effects. Ayurvedic treatment is found to be effective in the management of gouty arthritis with very few ill effects. But research works carried out in gout with Ayurvedic medicines are not yet compiled and analyzed. The purpose of this study is to conduct a systematic review of published data and gray literature on Ayurveda management of gout viz-à-viz Vatarakta to establish its safety and clinical effectiveness. Thus, finding more precise estimates of various Ayurveda interventions’ effects in the management of gout either as stand-alone or as an add-on to conventional management. Materials and methods: Source for data analysis involves electronic search done from PubMed, Cochrane Library (Cochrane Central Register of Controlled Trials: Issue 6 of 12, June 2018), AYUSH Research Portal (Govt. of India), DHARA, Google Scholar, Ancient Science of Life, Shodhganga@INFLIBNET, and online clinical trial registers. Manual search in central and departmental libraries of Government Ayurveda College, Trivandrum and IPGT & RA, Gujarat Ayurved University, Jamnagar. There will be no language restrictions. Studies published till date (until March 2019) will be sought. The search will be rerun just before the final analyses, and further studies shall be retrieved for inclusion. Type of studies included randomized controlled trials (RCTs), quasi-experimental trials, single-group clinical trials, comparative clinical trials (CCTs), pragmatic trials, and review papers on Ayurvedic management of Gout, which will all be screened for data analysis. The study selection will follow the preferred reporting items for systematic review and meta-analysis guidelines. Data collection and synthesis: three investigators shall independently screen all citations and abstracts identified by a primary comprehensive search to sort out potentially eligible trials based on inclusion criteria. Data extraction forms for individual study shall be prepared and it may include methods, participant characteristics, intervention, and outcome. When disagreement persists or in case of ambiguity at the time of data extraction, efforts shall be initiated to obtain clarifications directly from authors/coauthors as much as possible. Primary data analysis of both the qualitative and quantitative data will be performed. Heterogeneity among trials will be assessed by inspecting forest plots. If heterogeneity is detected and it is still considered clinically meaningful to combine studies, then a random-effects model (Dersimonian–Laird Model) will be used. In cases where pooled estimates can be obtained, the systematic review will be followed by a meta-analysis (based on the homogeneity of the RCT methodological, appraisal will be done by Cochrane risk-of-bias tool for RCT); others would be presented by narrative synthesis [using Risk of Bias tool in non-randomised clinical trials/non-randomised controlled trials (NRCT)] and shall be represented in tabular and graphical form. The analysis of the systematically collected data shall be analyzed using R software. A sensitivity analysis, to investigate the robustness of the results to the quality components will be done, provided there are sufficient trials. A funnel plot will be utilized to indicate publication bias, heterogeneity of results, or differences in the methodological quality. Timelines: Data collection and analysis: 06 months (from the date of initiation). Journal selection and publication: 03 months (from the date of study completion). Dissemination: The systematic review will be published in a peer-reviewed journal. It will also be disseminated electronically and via print. The review may guide healthcare practices and policy framing in the treatment of gout with Ayurvedic interventions. Trial registration number: PROSPERO 2019: CRD42019131198.

PROTOCOL

Bhagwan Sahay Sharma, Bidhan Mahajon, Bhogavalli Chandra Sekhara Rao

A Study Protocol of a Prospective, Open-label, Single-arm, Clinical Trial to Evaluate the Efficacy of Classical Ayurveda Medicines in the Management of Vicharchika (Atopic Eczema)

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:7] [Pages No:27 - 33]

Keywords: Vicharchika,Ayurveda, Nalpamaradi taila, Panchatikta ghrita, Protocol

PDF  |  DOI: 10.5005/jras-10064-0070  |  Open Access |  How to cite  | 

Abstract

Background: In Ayurveda, Vicharchika (atopic eczema, AE) has been discussed under the heading of Kshudra kustha. It is a variety of inflammatory skin disorders diagnosed as a chronic, widespread, noninfective inflammatory condition that causes severe pruritus, erythema with variable degree of exudates and scaling, which can impact at any age. The etiology of AE is complex and not fully understood. Although the traditional Ayurveda medicine is used as an alternative therapy for AE, available evidence relating to its effectiveness and mechanism are not fully implicit. Hence, a protocol of a prospective, multicenter, single-arm, open-label clinical trial using traditional Ayurveda medicine to investigate the effectiveness, mechanism, and safety for patients with Vicharchika (eczema) is being reported. Materials and methods: This is a multicenter, single-arm, open-label clinical trial to evaluate the safety and efficacy of traditional Ayurveda formulations Panchatikta Ghrita and Nalpamaradi Taila in the management of Vicharchika (eczema). A total of 120 patients with Vicharchika (eczema) will be selected based on the inclusion and exclusion criteria. All the patients will be provided with classical Ayurvedic formulation, i.e., Panchatikta Ghrita 6 g orally twice daily before food and oil Nalpamaradi Taila 20 mL twice daily externally on the affected skin. Each participant will undergo a 12-week treatment period and a follow-up after 4 weeks. A total of seven visits will be scheduled for each participant: 1 visit each in week 0, week 2, week 4, week 6, week 8, week 10, and week 12. The primary outcome will be measured by the assessment of change in eczema area severity index (EASI) score before and after the recommended therapy. The secondary outcomes will be measured by—changes in clinical sign and symptoms per the Ayurvedic classics; changes in patient-oriented eczema measure (POEM) and changes in dermatology life quality index (DLQI) questionnaire. Therapeutic mechanism outcomes, safety outcomes, and end point outcomes will also be assessed. Discussion: Protocol was designed with projected outcome as better clinical deliverables and safety profile in Vicharchika patients and reduced relapse rate of disease during post treatment period. If found effective, the selected drug will be listed in the management protocol of Vicharchika at clinical practice level in terms of better efficacy, safety, and cost-effective treatment. The selected drug may lead to a step ahead of better understanding and management of additional skin disorders. Trial registration: Trial has been registered under clinical trials registry-India (CTRI); the registration number for this trial is CTRI/2019/12/022236.

CASE REPORT

Manjry A Barla, Rakesh Roushan

Ayurvedic Approach for Management of Uterine Fibroid: A Case Report

[Year:2019] [Month:January-March] [Volume:3] [Number:1] [Pages:5] [Pages No:34 - 38]

Keywords: Ayurvedic treatment regimen, Granthi, Leiomyomas, Uterine fibroid

PDF  |  DOI: 10.5005/jras-10064-0069  |  Open Access |  How to cite  | 

Abstract

A 31-year-old woman presented with uterine fibroid of 12.3 mm diameter in right lateral uterine wall and a cyst of 30 mm diameter in left ovary. She was intended to treat with some Ayurvedic formulations. Fibroids are the abnormal growths that develop in a woman\'s uterus. Sometimes these tumors are quite large and cause severe abdominal pain and heavy periods. In other cases, they cause no signs or symptoms at all. The growths are typically benign or noncancerous. The cause of fibroids is unknown. Fibroids are also called leiomyomas or myomas. Ayurvedic drugs have been proved useful for these manifestations. The case was treated for 14 months with a combination of different Ayurvedic drugs to alleviate symptoms and reduce the size of fibroid. Patient came with the complaint of excessive menstrual bleeding with pelvic pain and was diagnosed with uterine fibroid by ultrasonography (USG). This patient of uterine fibroid, diagnosed as Granthi was treated with Pradarantak rasa, Kanchnar guggulu, Arogyavardhini vati, Kumaryasava, Ashokarishta, and Pushyanuga churna during the treatment. Only oral Ayurvedic drugs were used during the treatment. Patient\'s condition was assessed for symptoms of uterine fibroid which was completely relieved. No evidence of uterine fibroid was seen in USG; therefore, it indicates the case of uterine fibroid successfully and completely cured with Ayurvedic treatment. Surgical removal of uterine fibroid or cyst is the only curative treatment in contemporary modern medical science. In Ayurveda, it may be successfully treated with oral Ayurvedic drugs and without surgical intervention.