Bhagwan Sahai Sharma

Background: The leading cause of disability worldwide is low back pain. The incidence of herniated disc is approximately 5 to 20 cases per 1000 adults per year, and herniated disc is prevalent in people in their third to fifth decade of life, with a male-to-female ratio of 2:1. In Ayurveda, the condition grudhrasi is considered analogous to radiculopathy. In conventional medicine, the first line of treatment includes conservative management, such as patient education, manual therapy, and nonsteroidal anti-inflammatory drugs. Ayurvedic treatments are used to manage lumbar radiculopathy. Objective: This clinical study aims to compare the safety and efficacy of an Ayurvedic treatment protocol with standard care in patients with lumbar disc herniation with radiculopathy. Methods: This is an open-label, randomized, controlled, parallel group clinical trial with a sample size of 80 participants who will be randomly allocated to 2 groups. The intervention group will receive an Ayurvedic treatment protocol, and the control group will be treated with conventional care, including physiotherapy, for a period of 60 days. The changes in the numeric pain rating scale and visual analog scale score and the Oswestry Disability Index (version 2.0) score will be considered the primary outcome measures and will be recorded at baseline (day 1) and on day 8 (after completing inpatient [IP] treatment), day 30, and day 60. The secondary outcome, quality of life, will be recorded at baseline (day 1) and on day 8 (after completing IP treatment), day 30, and day 60. The occurrence of adverse events and the need for rescue analgesic medications will be considered other secondary outcome measures and will be recorded on day 8 (after completing IP treatment), day 30, and day 60. Results: The study was funded in March 2023, and the study period is 36 months. Participant enrollment began in November 2023. A total of 136 participants were screened, of whom 80 were enrolled in the study. Data analysis is in progress, and the study outcomes are expected to be published by December 2026. Conclusions: The outcome of this trial may provide scientific evidence regarding the safety and efficacy of Ayurvedic treatment for lumbar disc herniation with radiculopathy. The study may also contribute to the development of evidence-based integrative management strategies and standardized treatment protocols for this condition. Trial Registration: Clinical Trial Registry of India CTRI/2023/05/052859; https://tinyurl.com/y6h4b5kb International Registered Report Identifier (IRRID): DERR1-10.2196/82936

Background: Parikarthika refers to the condition in which the individual experiences a sensation of pain as if the Guda is being cut around with scissors. This condition can be correlated to the fissure in ano. It has been described as an acute superficial break in the continuity of the anoderm, usually in the posterior midline of the anal canal. The incidence of anal fissures is around 1 in 350 adults. Management can be divided into conservative, operative, and adjuvant therapies. The main challenge in the management of fissure in ano is the increased rate of recurrence. Here comes the importance of an alternative therapy which can reduce the recurrence. The recurrence rate of fissure in ano by nonsurgical procedures is 60%, and with the Ayurveda protocol, the expected recurrence rate is 30%. Objective: This study aims to evaluate the efficacy of an Ayurvedic management protocol on the rate of recurrence, healing, and safety in Parikarthika (fissure in ano). Methods: A prospective, randomized controlled interventional open-labeled study has been designed to enroll a total of 90 participants from the OPD (Outpatient Department) of National Ayurveda Research Institute for Panchakarma (NARIP), Cheruthuruthy, Kerala. They will be screened for fissure in ano based on physical examination. Participants satisfying the inclusion and exclusion criteria will be randomly allocated to either the trial group (n=45) or the control group (n=45). In the trial group, participants will be managed with Avipattikar churna and Triphala guggulu internally and Jatyadi taila anal infiltration, as well as Lepana along with sitz bath in Triphala kashaya externally. Diltiazem gel will be given for external application in the control group along with Triphala kashaya sitz bath and Triphala churna internally. The intervention is given for a period of 28 days, and participants are evaluated on 14th, 28th, 56th, 84th, and 112 ^th day. The assessment parameters include recurrence rate, treatment efficacy, safety, comparative tolerability, and change in health-related quality of life. Results: This project was funded in June 2024, and the study duration is 36 months. The first participant was enrolled in April 2025; 9 participants were enrolled as of May 2025. The data analysis will be completed by October 2027 and the results are anticipated to be published by December 2027. Conclusions: The study is expected to demonstrate the efficacy of an Ayurvedic management protocol on the rate of recurrence, healing, and safety in Parikarthika (fissure in ano).

Background: Sickle cell disease (SCD) is a severe, inherited hemoglobin disorder characterized by chronic hemolysis, vaso-occlusive crises (VOCs), and systemic inflammation. Hydroxyurea is the standard conventional pharmacotherapy for SCD, but it has certain limitations, necessitating the need to explore other safe and effective treatment options for SCD. Ayurveda interventions offer a potential therapeutic approach complementary to conventional medicine for SCD management, with anti-inflammatory, immunomodulatory, and hematopoietic properties. Objective: This randomized controlled trial will evaluate the efficacy and safety of an Ayurvedic therapeutic regimen as an adjunct to hydroxyurea in SCD management, assessing its impact on hematological parameters, inflammatory biomarkers, VOC frequency, and overall quality of life. Methods: A PROBE (Prospective, Randomized, Open-Label, Blinded End Point) study will be conducted on individuals of any gender aged 18 years or older and diagnosed with SCD (with hemoglobin S levels more than 60% and a history of at least 1 VOC per year over the past 3 y). Individuals with acute VOC or any severe infection requiring hospitalization, a history of significant comorbidities, or hematopoietic stem cell transplantation will not be considered. The study will be conducted at the All India Institute of Medical Sciences, Bhopal, India. A total of 100 participants will undergo random assignment in a 1:1 ratio to receive either an Ayurveda regimen ( Dadimadi Ghrita , Punarnavadi Mandura , and Vasaguduchyadi Kwatha ) as an add-on to hydroxyurea or hydroxyurea alone for 8 months. The primary outcome will be a change in hemoglobin electrophoresis parameters (hemoglobin S, fetal hemoglobin, and adult hemoglobin) and the frequency of VOC episodes over 8 months. The secondary outcome measures include changes in the levels of proinflammatory markers (interleukin-6, interleukin-8, C-reactive protein, and transforming growth factor-β) and lactate dehydrogenase, frequency of hospitalization for VOCs and blood transfusions, and health-related quality of life (Short Form-8 Health Survey questionnaire). Safety will be evaluated by recording the incidence of adverse events and changes in liver and kidney function tests from baseline. Results: The recruitment of study participants was initiated on November 1, 2023. By the second week of February 2025, 83 participants had been enrolled in the study. The final study is expected to be complete by December 31, 2025. We will start the analysis of the study outcomes in February 2026, and the publication of the final results is expected by August 2026. Conclusions: This randomized controlled trial protocol outlines a rigorous study design aimed to explore the potential benefits of an integrated therapeutic regimen comprising Ayurveda interventions and standard conventional care in the long-term management of SCD through validated clinical and laboratory parameters. The outcomes of this study can address the needs and challenges associated with SCD management and inform future management protocols.

Background: Acute mountain sickness (AMS) poses a unique and formidable challenge to healthy personnel at high altitudes. Objective: This randomized controlled trial (RCT) protocol aimed to assess the effectiveness of Ayurvedic nutritional supplements in conjunction with a yoga protocol in reducing the incidence and severity of AMS among healthy personnel stationed in the challenging high-altitude landscapes of the western Himalayas. Methods: The proposed open-label, parallel-group RCT was conducted in apparently healthy individuals of any gender aged 18‐50 years. The study was conducted at two distinct high-altitude stages within the western Himalayan region: stage I, situated at an elevation ranging from 9000 to 12,000 feet and stage II, spanning 12,000 to 15,000 feet. A total of 1660 participants (n=830 per stage) underwent random assignment in a 1:1 ratio to receive either the existing acclimatization schedule (AS) for high altitude (control group) or the Ayush intervention (Ayush group) in addition to the AS. The participants in the Ayush group received Ayurvedic nutritional supplements, including the Ayur-nutri kit (Ayush poshak yoga, 25 g, and Ayush cardiac care tea, 125 mL), twice daily, along with a yoga protocol (60 min daily) for 120 days. The primary outcome was the incidence of AMS, assessed using the 2018 Lake Louise Scoring System, and the proportion of participants with a Lake Louise Scoring System score of 6 or higher during the first 7 days from baseline. The secondary outcome measures included the proportion of participants with thromboembolic events; changes in coagulation and hemostasis activation markers and proinflammatory markers; and changes in self-reported negative emotional states (depression, anxiety, and stress), sleep quality, and overall quality of life (assessed through Depression Anxiety Stress Scale-21 items, Pittsburgh Sleep Quality Index, and 12-item short-form, respectively) on day 60 and day 120 from baseline. Results: The study was funded in March 2023. The data collection was completed in December 2023. A total of 1660 participants were enrolled in the study. The analysis of the study data is in progress. The study outcomes are expected to be published by December 2026. Conclusions: This RCT was the first of its kind to explore the potential benefits of using Ayurvedic nutritional supplements and a yoga protocol in conjunction with the standard AS to reduce the occurrence and severity of AMS among healthy personnel. The outcomes of this trial can aid in better acclimatization and resilience among healthy personnel at high altitudes.

Background: Yonivarti (Ayurvedic vaginal suppository) possesses healing, anti-inflammatory, and antibacterial properties. Despite its therapeutic relevance, Pippalyadi Yonivarti (PV) and its suppository lack standardization and stability data. Materials and Method: PV was prepared in three batches (2 kg each), and Pippalyadi vaginal suppositories (PS) in batches of 200 units using the fusion method with a water-soluble base. Efforts have been made to develop standard operating procedures (SOPs), and quality control (QC) as per the Ayurvedic Pharmacopeia of India, and stability studies were evaluated as per International Conference on Harmonization (ICH) guidelines. Observations and Results: PV showed loss on drying: 8.19% ±0.96% (w/w), pH: 5.85 ± 0.06, water extractive value: 86.78% ±0.87% (w/w), alcohol extractive value: 31.36% ±0.63% (w/w), total ash value: 20.76% ±0.47% (w/w), acid insoluble ash: 0.21% ±0.015% (w/w), average weight: 2.91 ± 0.04, hardness: 2.12 ± 0.05 kg/cm ² , friability: 0.17% ±0.04% (w/w), and disintegration time (DT): 54 ± 13.6 min. The QC parameters for PS, including weight, melting range, pH, liquefaction, and DT, were within acceptable limits. High-performance thin-layer chromatography (HPTLC) quantification of PV showed 960 μg/100 mg of piperine and 524 μg/100 mg of dehydrocostus lactone, compared to PS. Observed differences were attributed to PS due to the poor aqueous solubility of ingredients. Stability tests indicated a shelf-life of 29 months for PV and 12 months for PS. Conclusion: SOPs, QC parameters, and HPTLC quantification confirm the reproducibility, safety, and stability of both formulations, reinforcing their suitability for incorporation into modern gynecological therapies.

BACKGROUND Background: Parikarthika refers to the condition in which the subject experiences a sensation of pain as if the Guda is being cut around with scissors. This condition can be correlated to the Fissure in ano. It has been described as an acute superficial break in the continuity of the anoderm usually in the posterior midline of the anal canal. The incidence of anal fissures is around 1 in 350 adults. The management can be divided into conservative, operative and adjuvant therapy. The main challenge in the management of Fissure in ano is the increased rate of recurrence. Here comes the importance of an alternative therapy which can reduce the recurrence. The recurrence rate of Fissure in Ano by nonsurgical procedure is 60% and that with the Ayurveda protocol, the expected recurrence rate is 30%. OBJECTIVE Objective: This study aims to evaluate the efficacy of an ayurvedic management protocol on the rate of recurrence, healing and safety in Parikarthika (Fissure in ano). METHODS Methods: A prospective, randomized controlled interventional open labelled study has been designed to enrol a total of 90 participants from OPD of NARIP Cheruthuruthy, Kerala. They will be screened for Fissure in ano based on physical examination. The participants satisfying inclusion and exclusion criteria will be randomly allocated to either trial group (n=45) or control group (n=45). In the trial group participants will be managed with Avipattikar churna, Triphala guggulu internally and Jatyadi taila anal infiltration as well as Lepana along with sitz bath in Triphala kashaya externally. Diltiazam gel will be given for external application in control group along with Triphala kashaya sitz bath and Triphala churna internally. The intervention is given for a period of 28 days and participants are evaluated on 14th, 28th, 56th, 84th and 112thday. The assessment parameters include recurrence rate, treatment efficacy, safety, comparative tolerability and change in health-related quality of life RESULTS Results: This project was funded in June 2024.The institutional ethics committees at National Ayurveda Research Institute for Panchakarma (03/01/2024/NARIP/Tech/786) approved this study. The first participant was enrolled in April 2025; 9 participants were enrolled as of May 2025. The results of the trial groups will be compared with that of the control group. Pre and post treatment assessments will be conducted at comparable moments in both groups, with baseline assessment. The subsequent assessments will be on 14th, 28th ,56th ,84th and 112th day. The results will be subjected to univariate and multivariate analysis using appropriate statistical methods. CONCLUSIONS Conclusions: The study is expected to demonstrate the efficacy of an ayurvedic management protocol on the rate of recurrence, healing and safety in Parikarthika (Fissure in Ano). CLINICALTRIAL Trial registration number: CTRI/2024/09/073793

Background: Ayurveda recommends a comprehensive therapeutic approach for osteoarthritis management. However, most of the published clinical studies on Ayurveda interventions for osteoarthritis management have addressed selected modalities of Ayurveda treatment rather than the holistic therapeutic regimen. Objective: This study aimed to assess the efficacy and safety of a multimodal Ayurveda treatment protocol in the long-term management of primary osteoarthritis of the knee compared with standard care. Methods: The proposed open-label, parallel-group randomized controlled trial was conducted in individuals of any gender aged 40 to 70 years and diagnosed with primary osteoarthritis of the knee as per the American College of Rheumatology criteria. Individuals with grade 4 radiographic changes in the affected knee (based on the Kellgren-Lawrence classification) and with comorbidities were not considered. The study was conducted at the All India Institute of Medical Sciences, New Delhi, India. A total of 150 participants underwent random assignment in a 1:1 ratio to receive either the Ayurveda treatment protocol or conventional standard care for 180 days. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index score from baseline. The secondary outcome measures included the change in the score for pain, stiffness, and physical function from baseline; change in the range of motion of the knee joint; change in the score of the numeric pain rating scale, Pain Disability Index, and 12-item short-form survey questionnaire (to assess health-related quality of life); change in highly sensitive C-reactive protein levels, interleukin-6 levels, magnetic resonance imaging scan findings, and dual-energy X-ray absorptiometry scan findings; and change in the need for rescue analgesic medication from baseline. Safety was evaluated by recording the incidence of adverse events and changes in liver and kidney function tests from baseline. Results: Recruitment of study participants commenced on October 11, 2022. Currently, all the participants completed the study and the analysis of the study outcomes is ongoing. Conclusions: This randomized controlled trial will be the first study to explore the potential benefits of a multimodal Ayurveda regimen (based on Ayurveda principles and scientific evidence) in the long-term management of osteoarthritis of the knee through validated subjective, laboratory, and imaging parameters. The outcomes of this study may address the needs and challenges associated with osteoarthritis management. Trial Registration: Clinical Trial Registry of India CTRI/2022/05/042792; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njk0MTM=&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/68306

BACKGROUND The single leading cause of disability worldwide is low back pain. The incidence of herniated disc is about 5-20 cases per 1000 adults per year and is prevalent in people in their third to fifth decade of life, with a male-to-female ratio of 2:1. In Ayurveda, disease Grudhrasi simulates radiculopathy. In modern medicine, the first line of treatment includes conservative management including patient education, manual therapy, and non-steroidal anti-inflammatory drugs (NSAIDs). Ayurveda treatment are used to manage lumbar radiculopathy. OBJECTIVE This clinical study aims to compare the safety and efficacy of Ayurveda treatment protocol with standard care in lumbar disc herniation with radiculopathy METHODS This is an open-labelled, randomized, controlled parallel group clinical trial with sample size of 80 participants to be randomly allocated into two groups. The intervention group receive Ayurveda treatment protocol and the control group will be treated with standard modern care including physiotherapy for a period of 60 days. The changes in Numeric pain assessment scale - VAS score and ODI (Oswestry disability index Version 2.0) score will be taken as the primary outcome measures and will be recorded at baseline (1st day), 8th day (after completing IP treatment), 30th day, and 60th day. The secondary outcome quality of life will be recorded at baseline (1st day), 8th day (after completing IP treatment), 30th day, and 60th day, occurrence of adverse events and need of rescue analgesic medications will be taken as other secondary outcome measures and will be recorded at 8th day (after completing IP treatment), 30th day, and 60th day. RESULTS The project was funded in March 2023, and the study period is 36 months. The participant enrollment was started on November 2023. As of May 2025, 58 participants completed the study. The data analysis will be completed by March 2026, and the results are expected to be published by May 2026. CONCLUSIONS Lumbar disc herniation with radiculopathy affects the quality of life in patients. Ayurveda offers sustainable relief for lumbar disc herniation with radiculopathy. This study will provide scientific evidence on the safety and efficacy of Ayurveda treatment protocol in lumbar disc herniation with radiculopathy CLINICALTRIAL Clinical Trial Registry of India (CTRI) (CTRI/2023/05/052859).

BACKGROUND Ayurveda recommends a comprehensive therapeutic approach for osteoarthritis management. However, most of the published clinical studies on Ayurveda interventions for osteoarthritis management have addressed selected modalities of Ayurveda treatment rather than the holistic therapeutic regimen. OBJECTIVE This study aimed to assess the efficacy and safety of a multimodal Ayurveda treatment protocol in the long-term management of primary osteoarthritis of the knee compared with standard care. METHODS The proposed open-label, parallel-group randomized controlled trial was conducted in individuals of any gender aged 40 to 70 years and diagnosed with primary osteoarthritis of the knee as per the American College of Rheumatology criteria. Individuals with grade 4 radiographic changes in the affected knee (based on the Kellgren-Lawrence classification) and with comorbidities were not considered. The study was conducted at the All India Institute of Medical Sciences, New Delhi, India. A total of 150 participants underwent random assignment in a 1:1 ratio to receive either the Ayurveda treatment protocol or conventional standard care for 180 days. The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index score from baseline. The secondary outcome measures included the change in the score for pain, stiffness, and physical function from baseline; change in the range of motion of the knee joint; change in the score of the numeric pain rating scale, Pain Disability Index, and 12-item short-form survey questionnaire (to assess health-related quality of life); change in highly sensitive C-reactive protein levels, interleukin-6 levels, magnetic resonance imaging scan findings, and dual-energy X-ray absorptiometry scan findings; and change in the need for rescue analgesic medication from baseline. Safety was evaluated by recording the incidence of adverse events and changes in liver and kidney function tests from baseline. RESULTS Recruitment of study participants commenced on October 11, 2022. Currently, all the participants completed the study and the analysis of the study outcomes is ongoing. CONCLUSIONS This randomized controlled trial will be the first study to explore the potential benefits of a multimodal Ayurveda regimen (based on Ayurveda principles and scientific evidence) in the long-term management of osteoarthritis of the knee through validated subjective, laboratory, and imaging parameters. The outcomes of this study may address the needs and challenges associated with osteoarthritis management. CLINICALTRIAL Clinical Trial Registry of India CTRI/2022/05/042792; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Njk0MTM=&Enc=&userName= INTERNATIONAL REGISTERED REPORT DERR1-10.2196/68306