Integrative oncology: Addressing the global challenges of cancer prevention and treatment.

The increase in cancer incidence and mortality is challenging current cancer care delivery globally, disproportionally affecting low- and middle-income countries (LMICs) when it comes to receiving evidence-based cancer prevention, treatment, and palliative and survivorship care. Patients in LMICs often rely on traditional, complementary, and integrative medicine (TCIM) that is more familiar, less costly, and widely available. However, spheres of influence and tensions between conventional medicine and TCIM can further disrupt efforts in evidence-based cancer care. Integrative oncology provides a framework to research and integrate safe, effective TCIM alongside conventional cancer treatment and can help bridge health care gaps in delivering evidence-informed, patient-centered care. This growing field uses lifestyle modifications, mind and body therapies (eg, acupuncture, massage, meditation, and yoga), and natural products to improve symptom management and quality of life among patients with cancer. On the basis of this review of the global challenges of cancer control and the current status of integrative oncology, the authors recommend: 1) educating and integrating TCIM providers into the cancer control workforce to promote risk reduction and culturally salient healthy life styles; 2) developing and testing TCIM interventions to address cancer symptoms or treatment-related adverse effects (eg, pain, insomnia, fatigue); and 3) disseminating and implementing evidence-based TCIM interventions as part of comprehensive palliative and survivorship care so patients from all cultures can live with or beyond cancer with respect, dignity, and vitality. With conventional medicine and TCIM united under a cohesive framework, integrative oncology may provide citizens of the world with access to safe, effective, evidence-informed, and culturally sensitive cancer care.

Health and demographic indicators of selected districts of India: An impact of Swasthya Rakshan Programme (SRP).

Swasthya Rakshan Programme (SRP) provides health care services through Ayurveda, an initiative of the Government of India that aims to survey and create alertness of essential health appliances to ameliorate society from its grassroots level. The present study aimed to survey the prevailing health standards of residents in certain districts of India and to record the prevalence of diseases among them according to their living conditions, food habits, lifestyle, education, occupation and other socio-economic status. Data was collected through a community-based cross-sectional survey conducted from April 2018 to March 2019 in 22 Districts of 19 states in India. A stratified multi-stage sampling design was adopted for the survey. Documentation of demographic profile, food habits, lifestyle, hygiene status, and existing health conditions was assessed. A pre-designed semi-structured questionnaire was used for the collection of the data. Before initiating the programme, written consent was obtained. In this study, from 162 selected villages/colonies/areas, a total of 562,913 population and 81,651 households were surveyed. Sixty-nine thousand three hundred nineteen patients were cared for various ailments through health camps. The study found that the most prevalent disease in the concerned population was 'Sandhivata' (Osteo-arthritis), that is, 43.0%, followed by 'Dourbalya' (Debility), that is, 11.7%. The study includes insightful analyses of comprehensive demographic and health indicators classified by various socio-economic categories. The collected data regarding the prevalence of diseases with their sociodemographic correlations may provide a better understanding of the locality and thus may help in all future health endeavours.

Effect of Ayurveda intervention in the integrated management of essential hypertension- a retrospective observational study.

BACKGROUND: A study titled 'Integration of AYUSH (Ayurveda) with National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)' implemented in India in three districts of three states, namely Bhilwara (Rajasthan), Gaya (Bihar), and Surendranagar (Gujarat) since 2015 for the management of various non-communicable diseases (NCDs) through integrated approach. OBJECTIVE(S): To evaluate the effect of Ayurveda medication, lifestyle modification, and Yoga in integration with standard care for the management of essential hypertension. MATERIAL AND METHODS: A retrospective analysis of the demographic and clinical records available from NPCDCS-AYUSH Integration Project was done. The data of participants with Essential Hypertension (EHTN), aged between 30 and 60 years, who had completed six months integrated management as per the treatment protocol of the NPCDCS-AYUSH Integration project between July 2018 and March 2019 were taken and distributed in two groups based on their intervention. Those advised for lifestyle modification and Yoga in addition to standard care with any of the five medicines/combinations i.e. Amlodipine or Atenolol or Amlodipine + Atenolol or Losartan or Telmisartan were assigned Group I and those who were given Ayurveda medication, lifestyle modification and Yoga in addition to standard care were assigned to Group II. The change in blood pressure was analysed and dose reduction/discontinuation of conventional medications was also observed. RESULTS: Data of 1938 participants who had completed treatment under the NPCDCS program was analysed. At the 6th month, systolic and diastolic blood pressure was significantly reduced (P < 0.01) in all categories of Group I and Group II from baseline. Further, the dose of conventional medicine was reduced in 33.1% of participants of Group I and in 30.4% participants of Group II when compared to 0 day while conventional medicines were discontinued in 15.1% of Group I and 36.7% of Group II participants. CONCLUSION: Ayurveda medication along with lifestyle management and Yoga effectively controls systolic and diastolic blood pressure and further helps in reducing/discontinuation of dose of conventional medicines in EHTN participants.

Efficacy and safety of Guduchighana Vati in asymptomatic and mild-to-moderate cases of coronavirus disease-19: A randomized controlled pilot study.

Background: Currently, there is no approved treatment for the management of coronavirus disease (COVID-19). Drug repurposing of existing medications could be a possible way to find out a novel therapeutic entity to combat the COVID-19. Aim: To determine the clinical efficacy and safety of an Ayurveda intervention (Guduchighana Vati) in asymptomatic and mild-to-moderate cases of COVID-19. Materials and methods: This was an open-label randomized controlled pilot study with a sample size of 30 participants (15 in each arm). The participants were asymptomatic or mild to moderate cases of COVID-19. Guduchighana Vati 500 mg twice daily for 10 days was administered in the study group and Hydroxychloroquine for 5 days in the control group. Paracetamol, Vitamin C, Multivitamin, and Zinc were also provided in the control group. The main outcome measures were to negative real-time reverse transcription-polymerase chain reaction (RT-PCR) assay for COVID-19, proportion of participants with negative RT-PCR for COVID-19 at 5th and 10th day, proportion of participants with clinical recovery, improvement in laboratory parameters, and incidence of adverse drug reaction/adverse event (ADR/AE). The results of RT-PCR and clinical recovery were compared between groups using Chi-square test. The data related to laboratory parameters were compared within group using paired sample t-test/Wilcoxon signed-rank test and between groups using independent sample t-test/Mann-Whitney test. Results: The proportion of participants with negative RT-PCR for COVID-19 in the Guduchighana Vati group (93.3%) was better as compared to the control group (66.6%) till 10th day of the study period. Though, the results are statistically not significant (P = 0.068). All the symptomatic patients in the Guduchighana Vati group clinically recovered whereas one patient remained symptomatic in the control group on the 5th day. No symptoms of COVID-19 were observed at 10th day in both the groups. No ADR/serious adverse event were observed during the study period in either of the groups. Conclusion: In this study on asymptomatic and mild to moderate cases of COVID-19, Guduchighana Vati showed numerically better proportion of participants with negative RT-PCR assay for COVID-19 and reduced time to clinical improvement which requires confirmation through studies with larger sample size. Although, the study outcomes are statistically not significant which may be due to small sample size.

Management of chronic pain with Jalaprakshalana (water-wash) Shodhita (processed) Bhanga (Cannabis sativa L.) in cancer patients with deprived quality of life: An open-label single arm clinical trial.

INTRODUCTION: Pain is a common and complex symptom of cancer having physical, social, spiritual and psychological aspects. Approximately 70%-80% of cancer patients experiences pain, as reported in India. Ayurveda recommends use of Shodhita (Processed) Bhanga (Cannabis) for the management of pain but no research yet carried out on its clinical effectiveness. OBJECTIVE: To assess the analgesic potential of Jala-Prakshalana (Water-wash) processed Cannabis sativa L. leaves powder in cancer patients with deprived quality of life (QOL) through openlabel single arm clinical trial. MATERIALS AND METHODS: Waterwash processed Cannabis leaves powder filled in capsule, was administered in 24 cancer patients with deprived QOL presenting complaints of pain, anxiety or depression; for a period of 4 weeks; in a dose of 250 mg thrice a day; along with 50 ml of cow's milk and 4 g of crystal sugar. Primary outcome i.e. pain was measured by Wong-Bakers FACES Pain Scale (FACES), Objective Pain Assessment (OPA) scale and Neuropathic Pain Scale (NPS). Secondary outcome namely anxiety was quantified by Hospital Anxiety and Depression Scale (HADS), QOL by FACT-G scale, performance score by Eastern Cooperative Oncology Group (ECOG) and Karnofsky score. RESULTS: Significant reduction in pain was found on FACES Pain Scale (P < 0.05), OPA (P < 0.05), NPS (P < 0.001), HADS (P < 0.001), FACT-G scale (P < 0.001), performance status score like ECOG (P < 0.05) and Karnofsky score (P < 0.01). CONCLUSION: Jalaprakshalana Shodhita Bhanga powder in a dose of 250 mg thrice per day; relieves cancerinduced pain, anxiety and depression significantly and does not cause any major adverse effect and withdrawal symptoms during trial period.

Effect of Ayurveda intervention, lifestyle modification and Yoga in prediabetic and type 2 diabetes under the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)-AYUSH integration project.

BACKGROUND: Type 2 diabetes is a lifestyle-related disorder that affects around 422 million individuals in India. Integration of AYUSH (Ayurveda) with the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) was conceived on pilot basis at Gaya, Bihar, to provide integrative treatment for non-communicable disease patients and to manage the burden of non-communicable diseases in India. OBJECTIVES: The objective of this study was to analyze the effect of Ayurveda intervention, lifestyle modification and Yoga in the management of type 2 diabetes under NPCDCS-AYUSH integration project. MATERIALS AND METHODS: A multi-centric, open-labeled, prospective, comparative clinical study was conducted at 17 community health centers and 1 district hospital. Population over 30 years of age was screened and prediabetic or type 2 diabetic individuals were enrolled in two cohorts, i.e., pre-diabetic (Cohort A) and type 2 diabetic (Cohort B). Each cohort was further divided into two groups: Group A1 was advised for lifestyle modification and Yoga and group A2 was given Ayurveda medication in addition to lifestyle modification and Yoga. Similarly, group B1 was advised for lifestyle modification and Yoga along with allopathic medication and group B2 was given Ayurveda medication, i.e., Mamajjaka, Amalaki and Guduchi powder in addition to lifestyle modification and Yoga along with allopathic medication. Treatment was given for 6 months. Data were analyzed through paired t-test. RESULTS: A significant reduction was observed in fasting blood sugar level in groups A2 and B2 (P = 0.001) and also in the postprandial blood sugar level in Groups A2 and B2 (P = 0.001). Further, improvement in subjective symptoms such as polyuria, polydipsia, polyphagia, blurred vision and weakness was found in all the groups, while non-healing ulcer does not show any improvement. CONCLUSION: The study reveals that Ayurveda intervention, i.e., Mamajjaka Churna (1 g), Amalaki Churna (3 g) and Guduchi Churna (3 g) two times a day effectively controls blood sugar level in pre-diabetic and type 2 diabetic patients and improves the disease management with lifestyle modification and Yogasana as well as with allopathic treatment.

The Ayurvedic Pharmacopoeia of India, development and perspectives.

ETHNOPHARMACOLOGICAL RELEVANCE: The Ayurvedic Pharmacopoeia of India (API) is a unique book of standards describing the quality, purity and strength of selected drugs that are manufactured, distributed, and sold by the licensed manufacturers in pan India. It is developed in two parts; the part one comprises of mono-monographs of medicinal substances of natural origin and part two includes selected compound formulations sourced from the schedule - I books under the Drugs and Cosmetics Act, 1940 comprising of popular Ayurvedic classics of different period of times. The first part of the Ayurvedic Formulary of India was published in 1978 and thereafter, the Ayurvedic Pharmacopoeia of India (mono-monograph) Part-I, Vol. I was published in the year 1989 and subsequently, the other volumes were published with their legalized status under Drugs and Cosmetics Act, 1940. AIM OF THE STUDY: The study was aimed to bring out the existing knowledge on the Ayurvedic pharmacopoeia with its chronological development reviewed from the ancient Vedic Compendia with its continuum in Ayurvedic classics of different period of time till recent past. MATERIALS AND METHODS: A literary search based on the ancient origin of Ayurveda was carried out. The drug making from the natural resources and utility of the knowledge exist in classical Ayurvedic works of different period of time till composition of the Ayurvedic Pharmacopoeia of India and its importance as official documents of Govt. of India for Standards of Ayurvedic Drugs and its perspectives have been discussed. RESULTS: The present paper reviews on the systemic development and different aspects of drug-making (Pharmacopoeia) with evidence lying in the 5000 years old work of India. During the systematic review of the various works of different period of times (ancient, medieval and modern), it was found that the Ayurvedic Pharmacopoeia of India has its development during 20th Century as an official document of Govt. of India comprising of single drugs monograph and compound formulations. CONCLUSION: In India, the development of the Indian Pharmacopoeia started in 20th Century on the recommendation of the Col. R.N. Chopra Committee and in 1978 the first part of the Ayurvedic formulary of India was published. Subsequently, the amendment in the drugs and cosmetics Act 1940 was brought in 1964 for regulation of the drugs in Indian Systems of Medicine (Ayurveda, Unani and Siddha). Later on the Ayurvedic Pharmacopoeia of India (Mono-Monograph) Part-I, Volume I, was published in the year 1989 and the other volumes were published subsequently in different years.

Chemical Characterization of an Ayurvedic Herbo-Mineral Formulation - Vasantakusumakara Rasa: A Potential Tool for Quality Assurance.

BACKGROUND: Herbo-mineral formulations of Ayurveda contain specified metals or minerals as composition, which have their beneficial effects on biological systems. These metals or minerals are transformed into non-toxic forms through meticulous procedures explained in Ayurveda. Though literature is available on quality aspects of such herbo-mineral formulations; contemporary science is raising concerns at regular intervals on such formulations. Thus, it becomes mandate to develop quality profiles of all formulations that contain metals or minerals in their composition. Considering this, it is planned to evaluate analytical profile of Vasantakusumakara Rasa. OBJECTIVE: To prepare Vasantakusumakara Rasa as per Standard operating Procedures (SoP) mentioned in classical text and to characterize it chemically using modern analytical techniques. MATERIALS AND METHODS: The drug (Vasantakusumakara Rasa) in three batches was prepared in GMP certified pharmacy. Physico-chemical analysis, Assay of elements and HPTLC were carried out as per API. XRD was conducted using Rigaku Ultima-IV X-ray diffractometer. RESULTS: The analysis shown the presence of Mercury, Tin, Gold, Silver, Iron, Zinc and Calcium etc., and HPTLC revealed presence of organic constituents from plant material. The XRD indicated the presence of cinnabar (mercury sulphide from Rasa Sindhura), cassiterite (tin oxide from Vanga Bhasma), massicot (lead oxide from Naga bhasma) and Magnetite (di-iron oxide from Loha bhasma). CONCLUSION: The physico chemical analysis reveals that VKR prepared by following classical guidelines is very effective in converting the macro elements into therapeutically effective medicines in micro form. Well prepared herbo-mineral drugs offer many advantages over plant medicines due to their longer shelf life, lesser doses, easy storing facilities, better palatability etc. The inferences and the standards laid down in this study certainly can be utilized as baseline data of standardization and QC.

Clinical study to assess the efficacy of Keshanjana and Netra Parisheka in the management of Shushkakshipaka (dry eye syndrome).

BACKGROUND: Dry eye syndrome (DES) is a common ophthalmic problem predominantly affecting middle-aged and elderly people. It is a disease of deficient or deranged tears and ocular surface disorder producing symptoms of discomfort, visual disturbance, and tears film instability. Shushkakshipaka, an etymologically and clinically similar entity to DES, is defined in Ayurveda as the disease affecting all parts of the eye characterized by Paka (inflammation) due to Shuskatva (dryness) caused by altered coherence of Ashru (tears) with ocular surface or due to lack of Ashru. AIM: To compare the effect of Keshanjana and Netra Parisheka in Shushkakshipaka with artificial tear drops (carboxy methyl cellulose [CMC]). MATERIALS AND METHODS: To search a safe, potent and cost-effective Ayurvedic treatment for DES, a randomized comparative clinical trial was conducted on 32 patients. Patients were divided in two groups 15 in group I and 17 in group II. Group I treated with artificial tear drop four times a day for topical use and group II treated with combination therapy of Keshanjana applied topically once a day and Netra Prisheka was done thrice a day. RESULTS: The effect of Ayurvedic management was found to be equivalent to the standard therapy, although the trial drugs provided more relief in foreign body sensation, burning sensation, dryness, pain, photophobia, itching, crusting, stuck eyelids, tear meniscus, conjunctival congestion, Schirmer I test, and tear film break-up time (TUBT). The standard therapy provided more relief than trial drugs in mucous discharges, transiently blurred vision, redness, and the presence of mucin debris in tear film. CONCLUSION: Keshanjana and Netra Parisheka can be used as a potent, safe and cost-effective treatment to ameliorate the symptoms of DES.

Quality control evaluation of Keshamasi, Keshanjana and Keshamasi eye ointment.

BACKGROUND: Keshanjana (collyrium) is a well known Ayurvedic preparation prepared out of Keshamasi (ash prepared by scalp hairs) mixed with Goghrita (cow's ghee). This medicine is indicated for the treatment of Shushkakshipaka (dry eye syndrome) in the classical literature of Ayurveda; hence, it was under taken for standardization and clinical evaluation in an extra-mural research project from Central Council for Research in Ayurvedic Sciences, Department of AYUSH, New Delhi. AIM: To develop standard quality parameters for the Keshamasi, Keshanjana and Keshamasi ointment. MATERIALS AND METHODS: Scalp hairs of male and females collected from saloons were converted to classical Masi Kalpana and mixed with cow ghee and petrolatum in the ratio of 1:5 to prepare the Keshanjana and Keshamasi ointment respectively. Standard Operation Procedure (SOP) were adopted and recorded accordingly. The raw material, furnished products and plain Goghrita were subjected for quality control parameters i.e., physico-chemical evaluation, anti-microbial study, particle size analysis, heavy metal analysis through inductive couple plasma spectroscopy with high performance thin layer liquid chromatography fingerprints. RESULTS: Rancidity was negative in all the samples, indicating that the physico-chemical parameters are in acceptable range. Lead and zinc were present in most of the samples; while all samples are were free from microbial contamination. CONCLUSION: As no standards are available to compare the results of the current study, the observations cannot be compared. Thus the profile generated in the current study can be considered as standard to refer in future studies.

A clinical study to evaluate the efficacy of Trataka Yoga Kriya and eye exercises (non-pharmocological methods) in the management of Timira (Ammetropia and Presbyopia).

Timira is a disease that can be attributed to wide range of clinical conditions starting from mild blurring of vision and having potential risk of permanent vision loss. According to the involvement of Dhatus (body elements) the condition can be grouped into two stages. The initial stage or Uttana, where the involvement of Dhatus is limited to Rasa, Rakta (blood), and Mamsa Dhatu (muscle tissue). When the Doshas are localized in the first and second Patala refractive error do happen and in presbyopia more emphasis is given to Mamsa Dhatu. In this study only Uttana stage of Timira was considered. The clinical study was done on 66 patients of Timira in two groups of four sub groups each of myopia, hypermetropia, astigmatism, and presbyopia. Group A was subjected to eye exercises (Bates method) and Group B was subjected to Trataka Yoga Kriya. After the enrolment of patients for this study, signs and symptoms were assessed both subjectively and objectively before, during, and after treatment. The study indicates that subjectively there are significant results in both the groups but objectively there is not much improvement.

Clinical efficacy of Ayurvedic management in computer vision syndrome: A pilot study.

Improper use of sense organs, violating the moral code of conduct, and the effect of the time are the three basic causative factors behind all the health problems. Computer, the knowledge bank of modern life, has emerged as a profession causing vision-related discomfort, ocular fatigue, and systemic effects. Computer Vision Syndrome (CVS) is the new nomenclature to the visual, ocular, and systemic symptoms arising due to the long time and improper working on the computer and is emerging as a pandemic in the 21(st) century. On critical analysis of the symptoms of CVS on Tridoshika theory of Ayurveda, as per the road map given by Acharya Charaka, it seems to be a Vata-Pittaja ocular cum systemic disease which needs systemic as well as topical treatment approach. Shatavaryaadi Churna (orally), Go-Ghrita Netra Tarpana (topically), and counseling regarding proper working conditions on computer were tried in 30 patients of CVS. In group I, where oral and local treatment was given, significant improvement in all the symptoms of CVS was observed, whereas in groups II and III, local treatment and counseling regarding proper working conditions, respectively, were given and showed insignificant results. The study verified the hypothesis that CVS in Ayurvedic perspective is a Vata-Pittaja disease affecting mainly eyes and body as a whole and needs a systemic intervention rather than topical ocular medication only.

A clinical study on Akshitarpana and combination of Akshitarpana with Nasya therapy in Timira with special reference to myopia.

Myopia, commonly referred to as shortsightedness, is the most common eye disease in the world with substantial social, educational, and economic impact. Some of the clinical features of Timira can be correlated with myopia. An open randomized clinical trial was conducted to evaluate the role of Tarpana with and without Nasya in patients suffering from myopia. In total, 41 patients were registered in two groups, out of which 30 patients completed the treatment. In Group A, Tarpana with Mahatriphaladya Ghrita and in Group B, Nasya with Abhijita taila followed by Tarpana with Mahatriphaladya Ghrita was administered. After enrollment of the patients in the study, the cardinal signs and symptoms of Timira - myopia, that is, visual acuity, clinical refraction, were evaluated before and after the treatment. Comparatively, more relief in the signs and symptoms were found in the Nasya group followed by the Tarpana group.