Journal of Research in Ayurvedic Sciences

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2019 | April-June | Volume 3 | Issue 2

EDITORIAL

Taking Standardized Prakriti Assessment Scale and AYUR Prakriti Web Portal to mainstream Ayurveda Education and Practice

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:1] [Pages No:00 - 00]

PDF  |  DOI: 10.5005/jras-3-2-v  |  Open Access |  How to cite  | 

ORIGINAL RESEARCH ARTICLE

Achintya Mitra, P Radhakrishnan, Debajyoti Das, Sophia Jameela, T Maheswar, Jayram Hazara, Kartar Singh Dhiman

Clinical Study to Evaluate the Efficacy and Safety of Comprehensive Ayurvedic Therapy in Plaque Psoriasis: An Open-label Multicentric Prospective Study

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:9] [Pages No:39 - 47]

Keywords: Panchakarma, Plaque psoriasis, Psoriasis area and severity index, Takradhara, Triphala Churna, Yasada Bhasma

PDF  |  DOI: 10.5005/jras-10064-0074  |  Open Access |  How to cite  | 

Abstract

Background: Psoriasis is a noninfectious chronic disease with unknown etiology, but multiple triggers and much comorbidity, characterized by well-defined dry scaly erythematous patches covered with adherent silvery white scales predominantly on the extensor surfaces. The risks and adverse effects of long-term contemporary therapy outweigh the benefits. Ayurveda approaches psoriasis as Vata-Kaphaja Kushtha and individualized approach to patient is advised. This study was done to assay the efficacy and safety of comprehensive Ayurvedic therapy, involving Panchakarma, Takradhara, and Rasayana in the management of plaque psoriasis. Objectives: To evaluate clinical efficacy and safety of comprehensive Ayurvedic therapy in psoriasis. Materials and methods: A prospective, open-label multicenter study was carried out at two peripheral centers of Central Council for Research in Ayurvedic Sciences (CCRAS). A total of 85 patients diagnosed with plaque psoriasis were recruited and administered Vamana Karma followed by Takradhara and Rasayana therapy. The total duration of therapy was 66 days. Assessment was done based on the relief in clinical symptoms of psoriasis, psoriasis area and severity index (PASI) score, and dermatology life quality index (DLQI). Safety assessment was done through analysis of liver function tests (LFTs) and kidney function tests (KFTs) before and after the trial period. Results: The treatment protocol provided statistically significant relief in symptoms of psoriasis, PASI, and DLQI. The PASI score improved from 23.594 at baseline to 5.199 at the end of trial with p value < 0.001. There was significant improvement in all parameters of DLQI at the end of 66th day and no adverse events (AEs) were noted during the trial period. The values of LFT and KFT were observed to be within limits during the entire period. Conclusion: Treatment protocol involving Panchakarma, Takradhara, and Rasayana was effective in producing relief in plaque psoriasis.

ORIGINAL RESEARCH ARTICLE

Ankush D Jadhav, Bhagwan Sahay Sharma

Evaluation of Gokshuradi Guggulu and Guduchi Churna in the Management of Type II Diabetes Mellitus (Madhumeha)

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:7] [Pages No:48 - 54]

Keywords: Gokshuradi Guggulu, Guduchi Churna, Madhumeha, Type II diabetes mellitus

PDF  |  DOI: 10.5005/jras-10064-0082  |  Open Access |  How to cite  | 

Abstract

Background: Diabetes mellitus (DM) has become an increasing global health problem among all socioeconomic groups, leading to various complications such as nephropathy, neuropathy, and retinopathy which are responsible for morbidity and mortality. Ayurvedic approach to pathogenesis of Madhumeha can provide solution in managing the incidence of diabetes among population by using various preparations. Gokshuradi Guggulu and Guduchi Churna are such Ayurvedic preparations. Objective: The objective of the study was to assess the clinical efficacy and safety of Gokshuradi Guggulu and Guduchi Churna in the management of type II DM using Diabetes Symptom Questionnaire (DSQ) score, short-form health survey (SF-36) score, and laboratory investigation. Materials and methods: It was an open-label, prospective, clinical trial conducted on 50 patients of type II DM (Madhumeha). Gokshuradi Guggulu 1 g (two tablets of 500 mg) twice daily after food (chew the tablets before swallowing) and Guduchi Churna 3 g twice daily after food with lukewarm water for 12 weeks were given to all study participants. The DSQ was assessed with the help of Visual Analog Scale (VAS; 0–10). Health-related quality of life was recorded at baseline and end of the 84th day by using RAND-36 items SF-36 questionnaire. In laboratory investigations, blood sugar levels, hematological parameters, renal function tests, liver function test, lipid profile, and glycated hemoglobin (HbA1c) were performed at baseline and at the end of 84th day for efficacy and safety evaluation of the drugs. Results: The DSQ score and clinical symptoms reduced significantly from baseline to the end of the treatment in 50 subjects aged between 30 years and 60 years of both sexes. The RAND SF-36 health survey showed an improvement in quality of life of all the participants. Conclusion: This study demonstrated the effectiveness of Gokshuradi Guggulu along with Guduchi Churna in the management of type II DM.

PROTOCOL

Kuldeep Choudhary, Parth P Dave, Sumeet Goel, Manohar S Gundeti

A Protocol for a Systematic Review to Study the Efficacy and Safety of Ayurveda Intervention in Children and Adolescent with Attention-deficit/Hyperactivity Disorder

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:5] [Pages No:55 - 59]

Keywords: Attention-deficit/hyperactivity disorder, Ayurveda, Ayurvedic intervention, Meta-analysis, Systematic review

PDF  |  DOI: 10.5005/jras-10064-0075  |  Open Access |  How to cite  | 

Abstract

Background: Various clinical researches have been done in Ayurveda to study the effectiveness of Ayurveda intervention in attention-deficit/hyperactivity disorder (ADHD), one of the most common neurodevelopmental disorders in pediatric population. However, to date, no comprehensive systematic review has been conducted to assess the quality of clinical trials conducted and to determine the strength and safety of Ayurveda interventions in ADHD. Materials and methods: Published randomized clinical trials (RCTs), non-RCTs, and unpublished data on Ayurveda intervention in ADHD will be searched by using electronic databases such as the Cochrane Library, Pubmed, CENTRAL, Science Direct, AYUSH research portal, and other Indian databases. It involves the hand-searching of Ayurveda journals, and PG/PhD dissertations, if available, will also be utilized. The selection of study, data extraction, and synthesis will be done independently by reviewers. Standard tools will be adopted to assess the quality of trials. Risk of bias assessment will be performed by using Cochrane tool of risk of bias for RCTs and risk of bias in non-randomized studies of interventions (ROBINS-I) tool for non-RCTs. A narrative synthesis of findings from included studies will be described by providing treatment effect size. If sufficient data are available, the meta-analysis will be performed by using Review Manager. Outcome: The proposed protocol will act as a guiding tool for reproducing the same results in a transparent manner and to provide information to healthcare practitioners and policy makers. Trial registration number: PROSPERO 2019 CRD42019129676.

PROTOCOL

Devi R Nair, PP Pradeep Kumar, E Remya

A Protocol for Systematic Review of Ayurvedic Interventions in Iron-deficiency Anemia

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:4] [Pages No:60 - 63]

Keywords: Ayurveda, Iron-deficiency anemia, Pandu

PDF  |  DOI: 10.5005/jras-10064-0076  |  Open Access |  How to cite  | 

Abstract

Background: In India, iron-deficiency anemia (IDA) among women is a problem of major health significance. This study reviews the clinical trials on Ayurvedic management of IDA to generate evidence on their safety and efficacy. Objectives: The primary objective of the present study is systematic review of selected studies and published clinical data in view of safety and efficacy of Ayurvedic interventions in the management of IDA. Materials and methods: Randomized controlled trials (RCTs), quasi-RCTs (QRCT), controlled clinical trials (CCTs), and multiple-arm clinical trials that are of at least 3 weeks’ duration will be included. Studies having patients fulfilling the diagnostic criteria based on the symptomatology of Pandu and IDA will be selected. Search strategy (for electronic search) Ayurveda OR Ayurvedic OR Ayurvedic treatment OR Pandu OR iron-deficiency anemia AND Mrit bhakshana janya pandu as titles, abstracts, or keywords from online databases will be searched. Three investigators shall independently screen all citations and abstracts identified by a primary comprehensive search to sort out potentially eligible trials. Full articles of potentially eligible trials shall be obtained and independently evaluated for inclusion in the review based on the participants (inclusion criteria). Data extraction forms for individual study shall be prepared. Dissemination: The results of systematic review will be disseminated manually and electronically in peer-reviewed journals. The present systematic review may help the health authorities in framing health policies more effectively. Trial registration number: PROSPERO 2019 CDR42019131191 Dated 29/07/2019.

PROTOCOL

V Krishna Kumar, Alok Kumar Srivastava, Pallavi N Kamble, Pratap Makhija

Safety and Efficacy of Ayurvedic Interventions in the Management of Conjunctivitis: A Protocol for a Systematic Review

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:4] [Pages No:64 - 67]

Keywords: Ayurveda, Conjunctivitis, Efficacy, Protocol for a systematic review, Safety

PDF  |  DOI: 10.5005/jras-10064-0077  |  Open Access |  How to cite  | 

Abstract

Background: Conjunctivitis is a common condition of the eye that occurs worldwide and affects all ages and social strata, affecting more than 2% of the population. Conventional treatment has many options for treating the disease. Despite adequate treatment options, patients continue to suffer troublesome symptoms. Complementary and alternative medicine (CAM) therapies may play a significant role here. Systematic reviews on this topic have been published for herbal medicines. Data are available on plenty of studies individually proving efficacy and safety of various Shodhana, Shamana, and Netra Kriyakalpa in conjunctivitis. However, systematic review of Ayurveda interventions for conjunctivitis is unavailable. This study aims at a thorough review of published clinical data of safety and efficacy of Ayurvedic interventions in the management of conjunctivitis. Materials and methods: A systematic review of randomized controlled trials (RCTs), quasi-randomized controlled trials (QRCTs), controlled clinical trials (CCTs), and multiple arms clinical trials on conjunctivitis published till date will be conducted. Studies having patients fulfilling the diagnostic criteria based on the symptomatology of Abhishyanda (HF-1) explained in classic Ayurveda texts and conjunctivitis of all ages and either sex will be included. Studies in which Ayurvedic treatments (Shamana, Shodhana, or/and Netra Kriyakalpa) with any dose, type, schedule, drug, dosage form, and advised Pathayapathya (lifestyle changes) as intervention or control will be selected. The primary outcome will be the response to treatment and onset of serious adverse events. Ethics and dissemination: Formal ethical approval will be obtained. The results will be disseminated through a peer-reviewed publication. Trial registration number: International prospective register for systematic reviews (PROSPERO) number CRD42019129436.

PROTOCOL

Shruti Khanduri, Sophia Jameela, Hetal Amin, K Anumol, Bhogavalli Chandrasekhara Rao

Clinical Evaluation of Efficacy and Safety of Classical Ayurveda Formulations, Panchatikta Ghrita and Nalpamaradi Taila, in the Management of Psoriasis: A Study Protocol

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:6] [Pages No:68 - 73]

Keywords: Ayurveda, Dermatology life quality index, Nalpamaradi Taila, Panchatikta Ghrita, Psoriasis area and severity index, Psoriasis

PDF  |  DOI: 10.5005/jras-10064-0079  |  Open Access |  How to cite  | 

Abstract

Background: Psoriasis is a common immune-mediated dermatological manifestation that has a significant impact on the physical, social, and psychological well-being of the individual. The most common cutaneous manifestation of the disease includes chronic, symmetrical, scaling papules, and plaques on an erythematous base. Ayurveda considers skin disorders under the spectrum of Kushta and those diseases that manifest with dryness, exfoliation, thick plaques, etc., are generally attributed to vitiation of Vata and Kapha Dosha with underlying Rakta Dhatu Dushti. Panchatikta Ghrita has been used for both Shodhanartha Snehapana (oleation for Shodhana purpose) and Shamana in skin diseases of varied origin. Nalpamaradi Taila is ideal in vitiation of Vata and Kapha Dosha while pacifying Pitta and Rakta Dushti. Materials and methods: A multicenter, open-label prospective study that is to be executed at two Institutes of Central Council for Research in Ayurvedic Sciences (CCRAS) which were dedicated to research of skin disorders. A total of 120 patients would be recruited for the trial (60 from each institute) and would be administered with Panchatikta Ghrita in the dose of 6 g twice daily before food, with lukewarm water as Anupana, while Nalpamaradi Taila will be given for external application over the affected areas twice daily for a duration of 12 weeks. The primary outcome will be change in psoriasis area and severity index (PASI) score from baseline to final visit and change in dermatology life quality index (DLQI) questionnaire will be the secondary outcome measure. The safety and tolerability of the formulations will be determined by clinical/biochemical assessments during the follow-ups. Paired t test would be used to assess the efficacy of the interventions at 12th and 14th week when compared with the baseline. Data will be collected and analyzed at CCRAS Headquarters using SPSS 15.0 software. Ethics and dissemination: Ethics approval has been obtained from the participating institutes. The results obtained will be submitted for publication in a peer-reviewed journal. Trial registration number: CTRI/2020/01/022844.

PROTOCOL

Bidhan Mahajon, Neha Dubey, Ashok Kumar Panda, Bhogavalli Chandrasekhara Rao

Traditional Ayurveda Medicines for the Management of Amlapitta (Functional Dyspepsia): A Study Protocol for a Prospective, Single-arm, Open-label Clinical Trial

[Year:2019] [Month:April-June] [Volume:3] [Number:2] [Pages:10] [Pages No:74 - 83]

Keywords: Amlapitta, Ayurveda medicine, Clinical trials, Functional dyspepsia, Treatment

PDF  |  DOI: 10.5005/jras-10064-0080  |  Open Access |  How to cite  | 

Abstract

Background: Amlapitta (functional dyspepsia, FD) is experienced as a heterogeneous group of upper abdominal symptoms characterized by upper abdominal colic or discomfort which may also comprise heartburn, bloating, regurgitation, early satiety, anorexia, postprandial fullness, belching, and nausea. Traditional Ayurveda medicines are frequently practiced for FD since long; however, available scientific proof relating to their competence and mechanism of actions are insubstantial. In this article, we report a protocol of a prospective, single-arm, open-label, multicenter clinical study by means of classical Ayurveda formulation to examine the effectiveness, mechanism, and safety of the patients diagnosed with Amlapitta (FD). Materials and methods: Present protocol is a single-arm, open-label multicenter clinical study to find the safety and efficacy of classical Ayurveda formulations Narikela Lavana and Amalakyadi Churna in the management of Amlapitta. A total of 110 patients with Amlapitta will be selected based on the inclusion and exclusion criteria. All the patients will be treated orally; with traditional Ayurveda medicine, i.e., powder Narikela Lavana 2 g, twice daily, before food; and Amalakyadi Churna 3 g, twice daily, after food. The entire participant will undergo 12-week treatment and 2-week follow-up. A total of seven visits will be scheduled for each of the participants, i.e., each one in week 0, 2, 4, 6, 8, 10, and 12. The primary outcomes include changes in FD symptoms in dyspepsia questionnaire; changes in symptoms of Amlapitta disease in Amlapitta symptom rating scale (ASRS) along with satisfactory therapeutic response. The secondary outcomes include disease relapse rate after successful treatment; assessment of quality of life in the participants of FD by the World Health Organization Quality of Life (WHO-QOL) scale; and psychological assessment by Beck\'s depression inventory scoring scale. Therapeutic mechanism outcomes, safety outcomes, and end-point outcomes will also be assessed. Discussion: Present protocol has been designed with expected better clinical outcome and safety profile in dyspepsia patients in addition to reduce relapse rate of disease during posttreatment period. If found effective, the selected drug will be listed in terms of better efficacy, safety, and cost-effective treatment of Amlapitta. The selected drug may lead to a step ahead of better understanding and management of other gastrointestinal disorders. Trial registration: Trial has been registered REF/2019/07/027369. The registration number for this trial is CTRI/2019/09/021133.