Journal of Research in Ayurvedic Sciences

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2017 | October-December | Volume 1 | Issue 4

EDITORIAL

Vaidya K S Dhiman

CCRAS R&D Policy toward Translational Research

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:1] [Pages No:0 - 0]

PDF  |  DOI: 10.5005/jras-1-4-vi  |  Open Access |  How to cite  | 

Book Review

Book Review

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:1] [Pages No:0 - 0]

PDF  |  DOI: 10.5005/jras-1-4-i  |  Open Access |  How to cite  | 

RESEARCH ARTICLE

Alok Srivastava, Vanmala B Wakode

Clinical Safety of Selected Ayurvedic Formulations in Common Eye Diseases

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:8] [Pages No:223 - 230]

Keywords: Triphala kwath,Allergic conjunctivitis, Anu taila, Computer vision syndrome, Dry eye syndrome, Mahatriphaladya ghrita

PDF  |  DOI: 10.5005/jp-journals-10064-0022  |  Open Access |  How to cite  | 

Abstract

Introduction: Allergic conjunctivitis (AC), dry eye syndrome (DES), and computer vision syndrome (CVS) are few of the eye diseases that commonly affect the working class. Allergic conjunctivitis is often associated with Kaphaja abhishyanda. Dry eye syndrome is caused due to chronic lack of sufficient lubrication and moisture on the surface of the eye. The CVS is a visual complaint that is clinically similar to DES. In Ayurveda, the symptoms of DES can be included under the spectrum of two different diseases, Krichronmeela and suskakshipaka. Tarpana, Aschyotana, Nasya, and oral use of Ayurvedic medicines are commonly advocated for eye diseases. Objective: Critical analysis and presentation of clinical safety and efficacy outcomes of classical Ayurvedic formulations, viz., Mahatriphaladya ghrita, Triphala kwatha, and Anu taila, in patients of common eye diseases. Materials and methods: Data were collected from three different clinical studies, viz., AC, DES, and CVS, that have been completed in peripheral institutes of Central Council for Research in Ayurvedic Sciences (CCRAS) and were critically evaluated to assay the safety profile of three drugs. Clinical safety assessments were done through analyzing liver function tests (LFTs) and kidney function tests (KFTs) before and after the trial period. Paired sample t-test was used to compare the mean changes from baseline to the end of the trial period. The study revealed that all the parameters were within the specified limits during the entire period. Conclusion: The findings in the three different clinical studies clearly reveal that Mahatriphaladya ghrita, Triphala kwath, and Anu taila are clinically safe, effective, and tolerable in common eye diseases.

RESEARCH ARTICLE

Milind Suryavanshi, Hari ML Meena, G Babu, Uday RS Namburi, Varanasi Subhose, Bhagwan S Sharma

Clinical Efficacy and Safety of “Vasavaleha” in the Management of Stable Chronic Bronchitis: A Prospective Open Label Multicenter Study

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:7] [Pages No:231 - 237]

Keywords: Kasa roga, St. George Respiratory Questionnaire, Stable chronic bronchitis, Vasavaleha

PDF  |  DOI: 10.5005/jp-journals-10064-0023  |  Open Access |  How to cite  | 

Abstract

Introduction: Chronic bronchitis is one of the common clinical problems seen in middle–older age group and occurs as a result of inflammation and swelling of the lining of the airways, leading to narrowing and obstruction generally resulting in persistent cough, associated with wheezing, chest pain, and shortness of breath. Chronic bronchitis can be symptomatically compared with Kasa Roga in Ayurveda. Aims and objectives: To evaluate the efficacy and safety of Vasavaleha in patients suffering from stable chronic bronchitis (CB). Materials and methods: A prospective, open label multicenter study was carried out at three peripheral units under intramural clinical research program from 2012 to 2013. One hundred and twenty six patients satisfying the selection criteria were enrolled at the Outpatient Department of the centers and were administered Vasavaleha (10 gm) twice daily after food with water for 12 weeks. Follow-up was done finally after 2 weeks without medication. Laboratory parameters were assessed at baseline, 42nd day, and at the end of the treatment period of 12 weeks (i.e., 84th day). Paired sample t-test was used to compare mean change from baseline to the 84th day. A p-value of <0.05 was considered significant. Results: At the end of 12 weeks, statistically significant improvement was observed in clinical symptoms of CB and also in peak expiratory flow rates (PEFR), forced expiratory volume (FEV1), and St. George Respiratory Questionnaire (SRGQ) Score (p < 0.001). The treatment was found to be safe and effective in the patients of CB as all the safety parameters were within the normal range. No adverse drug reaction or adverse event was reported during the trial period. Conclusion: Vasavaleha in the above prescribed dose is found to be effective and safe in the management of stable CB.

RESEARCH ARTICLE

Valiparambil C Deep, Sangeeta Sangvikar, Bhagwan S Sharma, Bhogavalli CS Rao, Bharti , Madan M Padhi

Clinical Evaluation of Classical Ayurvedic Formulations Simhanada Guggulu and Brihat Saindhavadi Taila in the Management of Rheumatoid Arthritis (Amavata): A Multicentric Open Label Prospective Study

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:9] [Pages No:238 - 246]

Keywords: Simhanada Guggulu,Amavata, Brihat saindhavadi taila, Rheumatoid Arthritis

PDF  |  DOI: 10.5005/jp-journals-10064-0024  |  Open Access |  How to cite  | 

Abstract

Introduction: Rheumatoid arthritis (RA) is a chronic, progressive, inflammatory autoimmune disease associated with articular, extra-articular, and systemic effects. Similar symptoms are found in Amavata described in Ayurveda. Simhanada Guggulu and Brihat Saindhavadi Taila are classical formulations that are used commonly in the management of Amavata. Aims and objectives: To assess the clinical efficacy and safety of the classical Ayurvedic formulations Simhanada Guggulu and Brihat Saindhavadi Taila in patients with RA. Materials and methods: A prospective, open label, multicenter study was carried out at two peripheral centers of the Central Council for Research in Ayurvedic Sciences (CCRAS). A total of 111 patients were administered Simhanada Guggulu and Brihat Saindhavadi Taila in the dose of 1.5 gm (3 tablets of 500 mg each) twice daily after food with lukewarm water and local application twice a day respectively, for a period of 12 weeks. Clinical assessment of symptoms, disease activity score-28 (DAS-28), short form 36 (SF-36), and disability index scoring were done at the baseline and at every subsequent visit at an interval of 14 days up to the 12th week and also in the follow-up without medication at the end of the 14th week. Paired sample t-test was used to compare mean change from baseline to 12th and 14th week respectively. Results: At the end of 12 weeks, statistically significant changes in symptoms, DAS 28, SF-36, and disability index score with p-value <0.001 were observed, compared with baseline. No adverse drug reaction (ADR)/adverse events (AEs) were reported during and after the trial. Conclusion: Simhanada Guggulu and Brihat Saindhavadi Taila administered together in the above-mentioned dose were found effective, safe, and tolerable in patients with RA.

RESEARCH ARTICLE

Alok Srivastav, Sanjaykumar Singh, Vanmala B Wakode, Madan M Padhi

Clinical Efficacy and Safety of Mahatriphaladya Ghrita in the Management of Allergic Conjunctivitis: A Prospective Open Label Multicenter Study

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:7] [Pages No:247 - 253]

Keywords: Allergic conjunctivitis, Mahatriphaladya Ghrita, Triphala Kwath

PDF  |  DOI: 10.5005/jp-journals-10064-0025  |  Open Access |  How to cite  | 

Abstract

Introduction: Allergic conjunctivitis is a mild, nonspecific inflammation of the conjunctiva due to allergy with symptoms of conjunctival congestion, mild papillary response, and intense itching without any known specific condition for pathology to develop or with undetermined etiology that is mostly and easily attributed to allergy. Aims and objectives: To evaluate the efficacy and safety of Mahatriphaladya Ghrita and Triphala Kwath (Aschyotana) in patients suffering from allergic conjunctivitis. Materials and methods: A prospective, open label multicenter study was carried out at two peripheral centers of the Central Council for Research in Ayurvedic Sciences (CCRAS). Totally, 54 patients satisfying the selection criteria were enrolled from the outpatient department (OPD) of these centers and were administered Mahatriphaladya Ghrita (15 mL) twice daily on an empty stomach in the morning and 3 hours before meals in the evening with lukewarm water for 12 weeks and Triphala Kvatha (10 drops) Aschyotana twice daily for 12 weeks. All the participants were subjected to complete physical and ophthalmic examination along with blood investigations. Follow-up was done finally after 2 weeks without medication. Laboratory parameters, viz., absolute eosinophil count (AEC), liver function tests, kidney function tests, lipid profile, total leukocyte count (TLC) were assessed at baseline and at the end of the treatment period of 12 weeks (i.e., 84th day). Paired sample t-test was used to compare mean change from baseline to the 84th day on the outcome variables assessed by visual analog scale (VAS, 0–100 mm) and on the laboratory examination. A p-value of <0.05 was considered significant. Results: At the end of 12 weeks, compared with baseline, statistically significant improvement was observed in symptoms, viz., redness, anxiety, lacrimation, photophobia, burning, and foreign body sensation (p < 0.001). The treatment was found to be safe and effective in the subjects of allergic conjunctivitis as all the safety parameters were within the stipulated range. No adverse drug reactions or adverse events were reported during the trial period. Conclusion: Mahatriphaladya Ghrita and Triphala Kwath (Aschyotana) administered in the above-mentioned dose were found effective and safe in patients suffering from allergic conjunctivitis.

RESEARCH ARTICLE

Aarti Sheetal

Selected Ayurvedic Formulations in Gynecological Disorders: A Clinical Safety and Pharmacoepidemiological Perspective

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:9] [Pages No:254 - 262]

Keywords: Pravala Pishti, Rajahpravartini vati, Varunadi Kashaya,Ashokarishta, Ashvagandha Churna, Clinical safety, Kanchnar Guggulu

PDF  |  DOI: 10.5005/jp-journals-10064-0026  |  Open Access |  How to cite  | 

Abstract

Background: Nowadays, safety of a drug is a major challenge than its efficacy. As the demand for Ayurvedic drugs is increasing day by day, the reporting of safety is essential. Objective: To review the clinical safety of Ayurvedic formulations, viz., Rajahpravartini vati Kanchanara Guggulu, Varunadi Kashaya, Ashokarishta, Ashvagandha Churna, and Pravala Pishti, which were trialed in 3 clinical trials on women\'s health to assess their efficacy and also clinical safety. Materials and methods: The analyzed data of 03 clinical studies on Kastartava (dysmenorrhea), menopausal syndrome, and polycystic ovary syndrome (PCOS) were collected from the Central Council for Research in Ayurvedic Sciences (CCRAS) database. These studies were conducted at 9, 3, and 2 centers on 359, 115, and 60 cases respectively, at the CCRAS institutes. The data have been critically evaluated to assay the clinical safety of the named six drugs trialed in these studies. All the studies were approved by the Institutional Ethics Committee conducted following the guidelines of good clinical practice. Written consent was obtained from the participants before their enrolment. Safety assessments were done by analyzing the laboratory parameters like liver function test and kidney function test before and after the trial periods. Paired sample t-test was used to compare the mean score. Any adverse drug reactions (ADRs) and side effects were also critically monitored. Results: In all the studies, it is observed that the safety laboratory parameters were within the normal range after drug administration in the participants, who were from different age groups, habitats, and prakriti. No cases of any ADR or drug intolerability were reported during the treatment period. Conclusion: From the results, it may be concluded that all the trial drugs are safe to use and can be used for a long period. Clinical significance: The results of the present study support the notion that if any Ayurvedic formulation has been manufactured as per good manufacturing practices (GMP) and administered at the recommended dose and duration, it is safe for human use.

SHORT COMMUNICATION

Manohar S Gundeti, Thrigulla Sakethram, Sneha S Marlewar, Laxman Bhurke, Amrish Dedge, Elavana Remya

Comprehensive Integrated Format for Systematic Documentation of Cancer Management through Ayurveda Interventions

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:20] [Pages No:263 - 282]

Keywords: Ayurveda, Cancer, Cancer case record format, National cancer institute best case series, Systematic documentation

PDF  |  DOI: 10.5005/jp-journals-10064-0027  |  Open Access |  How to cite  | 

Abstract

Introduction: There is an upsurge in use of complementary alternative medicines including Ayurveda among cancer patients. A systematic review of published data has shown that evidence for effectiveness of Ayurveda as add-on to conventional cancer treatment is substantial in comparison to standalone. However, there is a need for robust documentation of the cancer case management involving Ayurvedic interventions. National Cancer Institute Best Case Series program aims at systematic documentation of management using unconventional therapies for cancer for identification of novel therapies. However, a comprehensive integrated case format needs to be evolved at this juncture. Aim: To develop comprehensively integrated case record format for systematic documentation of cancer management through Ayurveda interventions. Results: Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute (RRAP-CARIC) under Central Council for Research in Ayurvedic Sciences (CCRAS) has developed Cancer Case Record Format (CCRF), a comprehensive integrated format for systematic documentation including demography, definitive diagnosis, clinical examination, treatment and disease response, etc. of cancer patients after wide consultation process and pretesting on more than 500 cancer patients. Clinical significance: This may be well utilized as a tool for uniform documentation by students, scientists, researchers, and physicians.

CASE REPORT

Govind R Reddy, Manisha Talekar

Nonhealing Ulcer treated with Jalaukāvacāraṇa (Bloodletting): A Single Case Study

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:5] [Pages No:283 - 287]

Keywords: Jalaukāvacāraṇa, Nonhealing ulcer, Raktamokṣ aṇa, Visrāvaṇa

PDF  |  DOI: 10.5005/jp-journals-10064-0028  |  Open Access |  How to cite  | 

Abstract

Chronic leg ulcers are a major cause of mortality and morbidity. The efficacy of hyperbaric oxygen treatment is being evaluated in the management of nonhealing leg ulcers to improve skin graft survival. We are presenting a case of nonhealing ulcer where skin graft was rejected three succeeding times. Súrūta has indicated Visrāvaṇa or Raktamokṣaṇa (bloodletting) in the management of ulcers. Jalaukāvacāraṇa (leech application) is one of the methods of Raktamokṣaṇa (bloodletting). A case report of 27-year-old female patient was presented with the complaints of swelling over the right ankle joint, with chronic lymphadenitis referred by the plastic surgeon. She was diagnosed as nonhealing ulcer and was treated by the plastic surgeon and skin grafting was performed. But it failed three succeeding times. Her constitution rejected all three skin grafts. This patient was then treated with Jalaukāvacāraṇa (bloodletting through leech application) after fourth time skin graft and it was accepted thereafter.

CASE REPORT

Rajkala P Patil, Anup B Thakar, Panchakshari D Patil

Spinal Injury-induced Paraplegia Improvement after Panchakarma

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:8] [Pages No:288 - 295]

Keywords: Adharangaghata, Panchakarma, Yapana basti

PDF  |  DOI: 10.5005/jp-journals-10064-0029  |  Open Access |  How to cite  | 

Abstract

Spinal cord injury (SCI) is life-disrupting condition. Historically, it has been associated with very high mortality rates. Paraplegia is impairment of the motor or sensory functions of the lower extremities often including the lower part of the trunk. It is usually caused by SCI. The area of spinal canal that is affected in paraplegia is the thoracic, lumbar, or sacral regions. Here, an attempt is made to explain the case of a 26-year-old female with burst fracture L1 (AO type A) with American Spinal Injury Association (ASIA) paraplegia with bowel bladder involvement due to a fall from height. Pedicle screw fixation was performed at three vertebral bodies (D12, L1, and L2). Even after surgery, complete motor and sensory deficit was present in bilateral lower limb, bowel, and bladder. According to the Ayurvedic view, patient was diagnosed as a case of “Adharanghata” and was planned for Panchakarma procedures as Udwartana (powder massage), Virechana, and Yapana Basti for 2 months. Outcomes: Patient\'s spinal cord independent measure (SCIM) score improved to 88/100, which was 51/100 at the beginning of Panchakarma. Patient developed motor and sensory activities of the lower limb without difficulty and also became independent in basic activities of daily living like bathing, toileting, climbing, etc. She became independent in instrumental activities of daily living like going to the market, hospital, and temple. After the above course of procedures, the patient showed marked improvements in sensory and motor modalities. The patient on wheelchair could now walk without support.

CASE REPORT

Integrated Ayurvedic and Allopathy Module of Management in Avaranajanya Madhumeha with Vibanda: Type II Diabetes with Metabolic Syndrome and Chronic Constipation

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:7] [Pages No:296 - 302]

Keywords: Case report, Integrated management, Madhumeha, Metabolic syndrome, Sthula pramehi, Type II diabetes,Avarana

PDF  |  DOI: 10.5005/jp-journals-10064-0030  |  Open Access |  How to cite  | 

Abstract

Rationale: This case illustrates the therapeutic potential of the Ayurvedic mode of management in a chronic type II diabetes mellitus (T2DM) patient with metabolic syndrome (MetS), where conventional treatment is unable to sustain the desired effects. It also tries to observe clinical reporting of any adverse drug interactions between Ayurveda and allopathy systems of medication. Background: A 55-year-old Indian male presented in May 2017 with complaints of poor glycemic control, despite taking oral hypoglycemic medication, hypertriglyceridemia, and chronic constipation with fullness of stomach, gas, and abdominal bloating. Patient was diabetic for the past 10 years, and constipation history is more than 20 years. He also presented with a history of hypertension for the past 2½ years and hypertriglyceridemia for the past 1 year. Intervention and outcome: After appropriate analysis of the patient based on Ayurvedic parameters, the patient was treated with a combination of medications along with his current allopathy medication. Lifestyle modification was also advised accordingly. By addressing the underlying cause of imbalance, his gastrointestinal tract (GIT) symptoms decreased, laboratory parameters of blood sugar and triglycerides showed improvement with better regulation and increased quality-of-life. No clinical adverse drug interactions were reported.

ORIGINAL ARTICLE

Deshmukh P Nareshrao

Consequences of Madhurarasa Atiyoga: A Case–Control Study

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:6] [Pages No:303 - 308]

Keywords: Risk factor,Karya-karaṇa vada, Madhurarasa

PDF  |  DOI: 10.5005/jp-journals-10064-0031  |  Open Access |  How to cite  | 

Abstract

Intorduction: According to classical Ayurvedic texts, balanced intake of madhurarasa in diet helps to maintain physiological health, but its excessive intake produces some signs and symptoms, such as Sthoulya, Aalasya, Nidradhikya, Anannabhilasha Agnimandya, Anaha, Galaganda, Gaṇdamala, Gala Shopha, and Asyamadhurya. Aims and objectives: To establish the relationship between excessive use of madhurarasa and signs/symptoms produced by it. Materials and methods: A case–control survey study was planned wherein totally 356 volunteers were interviewed personally. Subjects with particular symptoms were considered as a case, while healthy volunteers were considered as controls. To measure the excessive intake of madhurarasa, the quantity and frequency of common food items, such as dairy products, corn, pasta, starchy vegetables, cream, wheat, rice, sweet potatoes, banana, and dates are taken into consideration. Data were arranged in a 2 × 2 table and odds ratio (OR) was calculated for each symptom. Results: Odds ratio for Sthoulya, Aalasya, Nidradhikya, Anannabhilasha Agnimandya, Anaha, Gala Shopha, and Asyamadhurya with 95% confidence interval (CI) was found to be 1.92 (1.17–3.1), 1.28 (0.68–2.45), 1.89 (1.03–3.47), 1.32 (0.70–2.47), 1.82 (1.13–2.96), 1.93 (1.09–3.44), 2 (1.16–3.45), and 1.93 (1.18–3.14) respectively. Conclusion: From the above-obtained results, it is concluded that madhurarasa is a risk factor for Sthoulya, Nidradhikya, Agnimandya, Anaha, Galashopha, and Asyamadhurya. The study supports the Ayurvedic classical claim regarding atiyoga of madhurarasa.

PERSPECTIVE/OPINION ARTICLE

Jaiprakash B Ram

Ayurvedic Clinical Case Reporting: Need for Development of Consensus-based Supplementary Guidelines to Case Reporting Guidelines

[Year:2017] [Month:October-December] [Volume:1] [Number:4] [Pages:5] [Pages No:309 - 313]

Keywords: Ayurveda, Ayurvedic case reporting guidelines, CARE guidelines, Case report, Delphi technique

PDF  |  DOI: 10.5005/jp-journals-10064-0032  |  Open Access |  How to cite  | 

Abstract

Introduction: A clinical case report is a detailed narration that describes a medical problem for medical, scientific, or educational purposes, experienced by a medical practitioner in one or several patients. The case report (CARE) guidelines are designed to increase the completeness, accuracy and transparency of the case reports and also provide early signals of benefit, harm and value. Though many of the authors are publishing Ayurvedic case reports based on CARE guidelines but there is no uniformity of reporting Ayurvedic parameters among them. And till date no reporting guidelines based on Ayurvedic framework exists for Ayurvedic case reports. Diagnostic assessment and therapeutic intervention aspects of CARE checklist require Ayurvedic Specific Extension guidelines for Case reporting (AYUR-CASE). Materials and methods: All the relevant material for developing Ayurvedic specific extension to the CARE clinical case reporting guidelines are collected from the major Ayurveda texts with their commentaries. Electronic databases such as “PubMed,” “Google scholar search” and “Google search” were also used. Results: A list of important diagnostic as well as therapeutic aspects viz., Panchalakshana nidana, Ashtasthana pariksha, Dashvidh pariksha, Sodhana, Shamana, Rasayana, etc., mentioned in various samhitas are collected. As the related information is extensively documented in Ayurveda scriptures so it is critical to prioritize and select the necessary parameters, for which expert consensus need to be arrived at and hence the techniques like Delphi can be adopted for successful development of the AYUR-CASE guidelines. Conclusion: Ayurveda practice in the present day gives more valid results that are reproducible when the clinical approach and research protocol are based on fundamental principles of Ayurveda rather than the modern science. Hence to start a new chapter in the field of Ayurvedic Research—AYUR-CASE guidelines for case reporting has been proposed. These guidelines will help to achieve complete, accurate and transparent qualities of reporting clinical case reports in Ayurveda.