Ayurveda Management of Allergic Rhinitis: Protocol for a Randomized Controlled Trial.

BACKGROUND: Allergic rhinitis (AR) is the inflammation of the membranes lining the nose due to allergen exposure and is characterized by sneezing, nasal congestion, itching of the nose, or postnasal discharge. The prevalence varies worldwide, perhaps due to the geographic and aeroallergen differences, with 10% to 30% of the world's population experiencing AR. In this study, Anu Taila Nasya, Naradiya Laxmivilas Rasa, and Shirishadi Kwath will be compared to a fluticasone nasal spray. OBJECTIVE: The primary aim is to assess the efficacy of Ayurvedic management for AR (or vataja pratishyaya) by comparing it to a conventional control group. The secondary aims are to determine the mean change in the nasal endoscopy index and the mean change in the laboratory tests. METHODS: This ongoing study is an open-label randomized controlled interventional trial, with a sample size of 90 both in the trial and standard control group (including dropouts, 20%), and will be carried out for 24 months. Participants in the trial group will receive Ayurvedic treatment, that is, Anu Taila Nasya (6 drops in each nostril for 7 days for 3 consecutive weeks), Naradiya Laxmivilas Rasa (250 mg twice per day), and Shirishadi Kwath (40 ml twice per day for 45 days). The participants in the control group will receive a fluticasone propionate nasal spray (2 sprays once per day for 45 days). The primary outcome will include the mean change in the Control of Allergic Rhinitis and Asthma Test score, and the secondary outcomes will include the mean change in the nasal endoscopy index (assessment of nasal membrane color, pale or hyperemia; rhinorrhea, watery or yellow; and inferior turbinate swelling, hypertrophy) and the mean change in the laboratory tests. RESULTS: As of May 2024, 72 patients have been enrolled in both groups. Data analysis should be completed by February 2025. The study will be reported following standard guidelines for reporting randomized controlled trials. Clinical results will be disseminated through conferences and peer-reviewed publication in a relevant journal. CONCLUSIONS: The Ayurvedic approach could be an evidence-based therapeutic tactic for the management of AR. TRIAL REGISTRATION: Clinical Trials Registry India CTRI/2023/06/053395; https://tinyurl.com/564d2zz8. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56063.

Ayurvedic Management of Presbycusis (Project TOPMAC): Protocol for an Exploratory Randomized Controlled Trial.

BACKGROUND: Presbycusis is characterized by sensorineural hearing loss in both ears at high frequencies, which affects more than half of the older adults by the age of 75 years and is often accompanied by tinnitus and cognitive deterioration. Unfortunately, there are no treatments available to restore hearing loss. Treatment mainly focuses on improving the quality of life and communication with hearing aids. Traditional medicine like Ayurveda also explains ailments of a similar nature as Badhirya and advises using drugs with antiaging and neuroprotective activity for treatment. In Ayurveda, Badhirya and Karnanada (senile deafness with tinnitus) are due to vitiation of Vata Dosha. Treatments such as topical oil pooling (Karnapurana) are usually advised to counter Vata, improve hearing capacity, and reduce tinnitus. Kshirabala Taila, a medicated oil formulation prepared with Sida cordifolia Linnaeus, is one of the most preferred oils for topical oil pooling in such conditions, as it has a definitive indication for sensory dysfunctions. Drugs like Withania somnifera (L.) Dunal (Ashwagandha) are also used, as they ameliorate neurodegeneration and help to improve cognitive dysfunction. OBJECTIVE: We propose an exploratory randomized controlled trial study for evaluating the efficacy of TOPMAC (Topical Oil Pooling with Kshirabala Taila and Supplementation of Ashwagandha Churna) in tinnitus suppression and hearing and cognitive function protection in patients aged 60-75 years with mild to moderate presbycusis. METHODS: A parallel, 2-group, exploratory randomized controlled trial will be conducted in an Indian Ayurvedic research center at its outpatient service. Participants (N=60) with mild to moderate presbycusis will be recruited by screening. Participants will be randomized (computer-generated 1:1) to receive either basic treatment and health education (BTHE) or BTHE+TOPMAC for 24 weeks. The primary objective is to compare the efficacy of TOPMAC with that of BTHE in the protection of hearing function. The secondary objective is to compare the efficacy of TOPMAC with that of BTHE in tinnitus suppression and cognitive function protection. RESULTS: This project was funded in January 2023. The institutional ethics committees at National Ayurveda Research Institute for Panchakarma (3/1/2020/NARIP/Tech/2036) and Institute for Communicative and Cognitive Neuro Sciences (IEC006) approved this study. The first patient was enrolled in September 2023; 22 participants were enrolled as of August 2024. The data analysis is yet to start, and the results are expected to be published by January 2025. CONCLUSIONS: If this exploratory trial is proven effective, it will steer the setting of a definitive randomized controlled trial to test whether the TOPMAC intervention can be incorporated as a cost-effective integrative approach for managing presbycusis. The Indian government has already launched a National Program for Prevention and Control of Deafness to benefit the deaf population. TOPMAC may later be considered for integration with the national program. TRIAL REGISTRATION: Clinical Trials Registry India CTRI/2023/04/051485; https://tinyurl.com/2h2hry3n. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55089.

Efficacy and safety of AYUSH-64 as standalone or adjunct to standard care in COVID-19: a structured summary of protocol for a systematic review.

TRIAL REGISTRATION: Registered with PROSPERO ( CRD42021267844 ) dated 14.07.2021.

AYUSH 64, a polyherbal Ayurvedic formulation in Influenza-like illness - Results of a pilot study.

BACKGROUND: Influenza-like Illness (ILI) refers to a wide range of viral infections with an important cause of morbidity and mortality worldwide. The global incidence of ILI is estimated at 5-10% in adults and 20-30% in children. In India influenza accounts for 20-42% of monthly acute medical illness hospitalizations during the peak rainy season. AYUSH-64, a poly-herbal drug, is in practice for 40 years for various clinical conditions like fevers, microfilaremia, and inflammatory conditions. OBJECTIVE: A pilot study was conducted to evaluate the safety and efficacy of Ayurvedic formulation, AYUSH-64 in clinically diagnosed ILI for accelerating the recovery. MATERIAL AND METHODS: A prospective, open-label, nonrandomized, single group, single-center pilot clinical study with pre-test and post-test design was conducted at Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute for Cancer, Mumbai, an institute of Central Council for Research in Ayurvedic Sciences (CCRAS) between June 2018 and July 2019. A total of 38 participants of clinically diagnosed ILI (18-65 years) were studied with an one-week intervention of 'AYUSH 64' in a dose of 3 gm/day and three weeks post-treatment observation period. Assessment of parameters viz. improvement in the symptoms of ILI, frequency of usage of acetaminophen, antihistaminic and cough syrup, hematology, liver function and kidney function tests along with incidence of secondary complications, and time to return to a normal routine was done. RESULTS: One-week intervention of AYUSH 64 helped to recover from ILI symptoms with reduced frequency of usage of acetaminophen and antihistaminic. The intervention was safe on hematology and biochemical parameters. No serious adverse effects were observed during the study. CONCLUSION: AYUSH 64 along-with standard care in ILI is safe and efficacious and this may be used in other viral infections with pyrexia as add-on to standard care for early recovery and better outcome.

Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: Primary Objective • To assess the efficacy of Ayurveda interventions and Yoga in rehabilitation of COVID-19 cases suffering with long term effects of COVID 19 as compared to WHO Rehabilitation Self-Management after COVID-19- Related Illness. Secondary Objective • To assess the safety of Ayurvedic interventions in cases suffering with long term effects of COVID 19 TRIAL DESIGN: Multi-centric, randomized, controlled, parallel group, open-label, exploratory study. The study duration is 9 months and the intervention period is 90 days from the day of enrolment of the participant. PARTICIPANTS: Patients of either sex between 18 to 60 years, ambulatory, willing to participate, with history (not more than 4 weeks) of positive RT-PCR for COVID-19 or IgM antibodies positivity for SARS CoV-2, but having negative RT-PCR for COVID-19 at the time of screening will be considered eligible for enrolment in the study. Critically ill patients with ARDS (acute respiratory distress syndrome), requiring invasive respiratory support in the intensive care unit, known case of any malignancy, immune-compromised state (e.g. HIV), diabetes mellitus, active pulmonary tuberculosis, past history of any chronic respiratory disease, motor neuron disease, multiple sclerosis, stroke, impaired cognition, atrial fibrillation, acute coronary syndrome, myocardial infarction, severe arrhythmia, concurrent serious hepatic disease or renal disease, pregnant or lactating women, patients on immunosuppressive medications, history of hypersensitivity to the trial drugs or their ingredients, depressive illness (before COVID-19), diagnosed psychotic illnesses, substance dependence or alcoholism will be excluded. The trial will be conducted at two medical colleges in Maharashtra, India. INTERVENTION AND COMPARATOR: Intervention Arm (Group-I): Ayurveda interventions including Agastya Haritaki six gram and Ashwagandha tablet 500 mg twice daily orally after meals with warm water and two sessions of yoga (morning 30 minutes and evening 15 minutes) daily for 90 days, as per the post-COVID-19 care protocol provided in National Clinical Management Protocol based on Ayurveda and Yoga for management of COVID-19 published by Ministry of AYUSH, Government of India. Comparator Arm (Group-II): WHO Rehabilitation Self-Management after COVID-19 related illness for 90 days. The trial drugs are being procured from a GMP certified pharmaceutical company. MAIN OUTCOMES: Primary Outcome: Change in respiratory function to be assessed by San Diego shortness of breath Questionnaire, 6-minutes walk test and pulmonary function test. SECONDARY OUTCOMES: Change in High-resolution Computed Tomography (HRCT) Chest Change in Fatigue score assessed by Modified Fatigue Impact Scale Change in Anxiety score assessed by Hospital Anxiety and Depression Scale Score Change in Sleep Quality assessed by Pittsburgh Sleep Quality Index Change in the quality of life assessed by COV19-QoL scale Safety of the interventions will be assessed by comparing hematological and biochemical investigations before and after the intervention period and Adverse Event/ Adverse drug reaction TIMELINES FOR OUTCOME ASSESSMENT: Subjective parameters and clinical assessment will be assessed at baseline, 15th day, 30th day, 60th day and 90th day. Laboratory parameters (CBC, LFT, KFT, HbA1c, Hs-CRP, D-dimer), Pulmonary function test and HRCT Chest will be done at baseline and after completion of study period i.e. 90th day. RANDOMISATION: Statistical package for Social Sciences (SPSS) version 15.0 is used to generate the random number sequences. The participants will be randomized to two study groups in the ratio of 1:1. BLINDING (MASKING): The study is open-label design. However, the outcome assessor will be kept blinded regarding the study group allocation of the participants. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) SAMPLE SIZE: The sample size for the study is calculated assuming improvement in 6-minutes walk test by 40 meter in Group I and a change of 10 meter in Group II with a standard deviation of 50 meter based on the results of the previous studies, with 95% Confidence Level (α = 0.05) and 80% power and expecting a dropout rate of 20%. The number of participants to be enrolled in the study should be approximately 55 in each group. Hence, a total of 110 participants will be enrolled in the trial at each study site. TRIAL STATUS: Participants' recruitment started on 1st May 2021. Anticipated end of recruitment is August 2021. Protocol number: CCRAS-01 Protocol version number: 1.1, 13th January 2021. TRIAL REGISTRATION: The trial is prospectively registered with the Clinical Trial Registry of India (CTRI) on 03rd March 2021 [ CTRI/2021/03/031686 ]. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Journal website (Additional file 1). This communication serves as a summary of the key elements of the full protocol.

Review of health-care services for older population in India and possibility of incorporating AYUSH in public health system for geriatric care.

BACKGROUND: In a developing country like India, which has 10.11% population of >60 years age and a projection of rise of the same by 300% in 2050, health care of elderly is an enormous challenge. The developed world has evolved many models for elderly care, for example, nursing home care, health insurance, etc. Indian Government has also taken multiple measures in this direction by initiating National Policy on Older Persons, 1999, the Maintenance and Welfare of Parents and Senior Citizens Act, 2007, the Old Age Pension Scheme, Rashtriya Vayoshri Yojana 2017, etc. However, there is a necessity that, India must rapidly adapt to the complex health related, social and economic challenges caused by these demographic changes. This may be an opportunity for innovation in the health system by developing a perspective for healthy and active aging, though it is a major challenge. Health care of the older people cannot be achieved unless total health, i.e., physical, social, economic, psychological, and spiritual aspects are addressed. OBJECTIVE: The objective is to study current policies regarding geriatric health care in India and to propose the possibility to develop a model to provide comprehensive and dedicated health-care services to the older population by integrating conventional and indigenous systems of medicine dwelling in the country. MATERIALS AND METHODS: Electronic search in various scientific journals for research and review articles; electronic along with hand searching of conference proceedings, brochures, government policy documents, press releases, Ayurveda classical texts, etc., regarding geriatric health care in India and model health-care facilities in other countries and regarding of AYUSH systems in geriatric health care in India. RESULTS: There is an urgent need of adaptation and modification in the National Health System to cater the actual requirements of the elderly with plans and strategies dedicated to face their health-related challenges. Adoption of inclusive health-care interventions, can improve health outcomes by making it more acceptable, accessible, and affordable. CONCLUSION: Integration of AYUSH at various levels of health-care delivery system can potentially contribute to provide unique newer dimensions to the field of geriatric care in India.