Efficacy and safety of the Ayurvedic herbal preparation Maharishi Amrit Kalash: a systematic review of randomized controlled trials.

Background: Maharishi Amrit Kalash (MAK) 4 and 5 are Ayurvedic herbal nutritional supplements that are believed to have beneficial effects on overall health and wellbeing. This study aimed to systematically review all available randomized controlled trials (RCTs) investigating the clinical effects and safety of MAK. Methods: We included RCTs on therapy, health promotion, and prevention for patients and healthy volunteers of all ages. We systematically searched MEDLINE (via PubMed), EMBASE (via Ovid), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), DHARA, Clinicaltrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform, and Google Scholar from inception through 7 May 2023, with no time or language restrictions. The risk of bias was assessed using the Cochrane Risk of Bias Tool version 1. The protocol was registered with PROSPERO before conducting the review (CRD42023421655). Results: Three RCTs with 418 study participants were included. Two studies were on breast cancer patients and one on healthy adults. The two studies on cancer evaluated the efficacy of MAK in reducing the side effects of chemotherapy in women with breast cancer. The study on healthy adults evaluated whether MAK has an effect on an age-related alertness task as an indicator of cognitive aging. Both studies on breast cancer patients found beneficial effects on performance status, anorexia, vomiting, and body weight. One study reported positive effects regarding stomatitis. Regarding visual alertness, results showed that individuals who received MAK improved in performance. None of the three included studies reported adverse events. The risk of bias was mixed. Due to the small number and heterogeneity of the RCTs, no meta-analysis could be performed. Conclusion: There is evidence that MAK may have supportive effects in chemotherapeutic treatments for breast cancer patients and for healthy individuals regarding visual discrimination. However, it is difficult to verify treatment effects due to the small number of RCTs and the mixed risk of bias. Furthermore, none of the included studies recorded adverse events. Therefore, further high-quality studies are warranted to confirm the potential health benefits of MAK and to determine its optimal dosage and duration of use. Systematic review registration: PROSPERO, CRD42023421655.

Ayurveda for a Type 1 Diabetes Patient with Peripheral Arterial Occlusive Disease: A Case Report.

INTRODUCTION: The effect of Ayurvedic therapy in type 2 diabetes (T2D) is well documented. For people with type 1 diabetes (T1D), there is little evidence on the applicability of Ayurvedic therapy. This case illustrates the course of Ayurvedic treatment in a person with T1D accompanied by peripheral arterial occlusive disease (PAOD). CASE PRESENTATION: The patient had insulin-dependent T1D since the age of 6 years. At 39 years of age, he developed progressive bilateral PAOD of the femoral arteries. He presented claudication symptoms at a walking distance of 150 m. Ten surgical interventions for recanalization have been performed. The PAOD put heavy psychological strains on the patient. He developed moderate depression with anxiety and complained of tinnitus and sleep disturbances. Through an initial outpatient Ayurvedic treatment mainly focused on dietary, lifestyle changes and phytotherapeutics, and a subsequent 6-week inpatient Ayurvedic treatment in India, a weight reduction of 12 kg, a reduction in insulin requirement to 65% of baseline, as well as a walking performance without restriction at a medium load could be achieved. The depression and inner tension retreated, and one-sided tinnitus and existing sleep disturbances dissolved completely. The lasting effect was still perceptible 5 months after the inpatient stay. CONCLUSIONS: For this person with T1D with PAOD, outpatient and inpatient Ayurvedic therapy could generate a significant improvement of his situation. The case demonstrates that people with T1D can benefit from using individualized Ayurvedic therapy. This case motivates to invest in Ayurvedic research for people with T1D and complications.Die Wirkung der ayurvedischen Therapie bei Typ-2-Diabetes (T2D) ist gut dokumentiert. Für Menschen mit Typ-1-Diabetes (T1D) gibt es kaum Belege für die Anwendbarkeit der ayurvedischen Therapie. Dieser Fall veranschaulicht den Verlauf einer ayurvedischen Behandlung bei einer Person mit T1D, begleitet von einer peripheren arteriellen Verschlusskrankheit (pAVK).Der Patient hatte seit seinem 6. Lebensjahr einen insulinabhängigen 'T1D'. Im Alter von 39 Jahren entwickelte er eine fortschreitende bilaterale periphere arterielle Verschlusskrankheit (pAVK) der Oberschenkelarterien. Bei einer Gehstrecke von 150 m zeigte er Claudicatio-Symptome. Es wurden 10 chirurgische Eingriffe zur Rekanalisation durchgeführt. Die pAVK stellte für den Patienten eine starke psychische Belastung dar. Er entwickelte eine mittelschwere Depression mit Angstzuständen und klagte über Tinnitus und Schlafstörungen. Durch eine erste ambulante ayurvedische Behandlung, die sich hauptsächlich auf Ernährungs-, Lebensstiländerungen und Phytotherapeutika konzentrierte, und eine anschließende 6-wöchige stationäre ayurvedische Behandlung in Indien wurde eine Gewichtsreduktion um 12 kg, eine Reduzierung des Insulinbedarfs auf 65% des Ausgangswerts sowie eine bedeutende Verbesserung der Gehstrecke erreicht. Die Depression und die innere Anspannung verschwanden, und der einseitige Tinnitus und bestehende Schlafstörungen lösten sich vollständig auf. Der nachhaltige Effekt war noch 5 Monate nach dem stationären Aufenthalt spürbar.Für diese Person mit T1D mit pAVK konnte eine ambulante und stationäre ayurvedische Therapie eine deutliche Verbesserung der Situation bewirken. Der Fall zeigt, dass Menschen mit T1D von einer individualisierten ayurvedischen Therapie profitieren können. Dieser Fall motiviert dazu, in die ayurvedische Forschung für Menschen mit T1D und Komplikationen zu investieren.

A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. in patients of diabetic sensory polyneuropathy.

BACKGROUND: In routine, Ayurveda practitioners prefer classical pharmaceutical form of herbal medicines in compare to modern extracts. OBJECTIVE: To explore the difference of efficiency between whole drug powder of Phyllanthus niruri plus root decoction of Sida cordifolia and modern extracts of the same in compared to placebo in patients of diabetic poly-neuropathy. MATERIAL AND METHODS: A randomized, partly-double-blinded, placebo-controlled trial evaluated the efficacy of two different pharmaceutical forms of herbal medicines over placebo in 90 patients (30 in each group) of diabetic sensory polyneuropathy for first three weeks period. After three weeks, active herbal medication groups were continued with their assigned medicaments for next 5 weeks period and all placebo-patients were randomized again into 2 groups of active medication and treated for next 8 weeks. Patients were assessed with Neuropathy Total Symptom Score 6 and sensation thresholds. RESULTS: Significant effect of both form of herbal medicines over placebo was found in aching pain [F (2, 49) = 6.79, p = 0.002], allodynia [F (2, 59) = 6.74, p = 0.002], burning pain [F (2, 82) = 14.66, p < 0.0001], numbness [F (2, 77) = 16.37, p < 0.0001] and pricking pain [F (2, 50) = 14.23, p < 0.0001]. After the 8 weeks period, no significant difference was identified between the effect of both the herbal treatment on aching pain (U = 220, p = 0.03), allodynia (U = 421.5, p = 0.29), burning pain (U = 881.5, p = 0.846), numbness (U = 778, p = 0.92) and pricking pain (U = 260, p = 0.15). CONCLUSION: Both herbal groups have significant effect to reduce NTSS-6 score in compare to placebo. No significant difference found between the effect of two different pharmaceutical forms of Phyllanthus niruri and S. cordifolia.

Ayurveda in Knee Osteoarthritis-Secondary Analyses of a Randomized Controlled Trial.

Background: Ayurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients. Methods: A total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied. Results: The RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 ± 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%. Conclusions: These secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models.

Reliability of Ayurvedic Diagnosis for Knee Osteoarthritis Patients: A Nested Diagnostic Study Within a Randomized Controlled Trial.

Background: Ayurveda is a traditional Indian system of medicine. The customized Ayurvedic approach consists of a combination of several diagnostic procedures and subsequent individualized therapeutic interventions. Evaluation of inter-rater reliability (IRR) of Ayurvedic diagnoses has rarely been performed. The aim of this study was to evaluate IRR of Ayurvedic diagnosis for patients with knee osteoarthritis. Methods: A diagnostic reliability study of 30 patients and 4 Ayurvedic experts was nested in a randomized controlled trial. Patients were diagnosed in a sequential order by all experts utilizing a semistructured patient history form. A nominal group technique as consensus procedure was performed to reach agreement on the items to be diagnosed. An IRR analysis using Fleiss' and Cohen's kappa statistics was performed to determine a chance-corrected measure of agreement among raters. Results: One hundred and twenty different ratings and 30 consensus ratings were performed and analyzed. While high percentages of agreement for main diagnostic entities and the final Ayurveda diagnosis (95% consensus agreement on main diagnosis) could be observed, this was not reflected in the corresponding kappa values, which largely yielded fair-to-poor inter-rater agreement kappas for central diagnostic aspects such as prakriti and agni (κ values between 0 and 0.4). Notably, agreement on disease-related entities was better than that on constitutional entities. Conclusions: This is the first diagnostic study embedded in a clinical trial on patients with knee osteoarthritis utilizing a multimodality whole systems approach. Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details. Future diagnostic studies should have larger sample sizes and a methodology more tailored to the specificities of traditional whole systems of medicine. Equal emphasis will need to be placed on all core diagnostic components of Ayurveda, both constitutional and disease specific, using detailed structured history taking forms.

A Complex Multiherbal Regimen Based on Ayurveda Medicine for the Management of Hepatic Cirrhosis Complicated by Ascites: Nonrandomized, Uncontrolled, Single Group, Open-Label Observational Clinical Study.

Hepatic cirrhosis is one of the leading causes of death worldwide, especially if complicated by ascites. This chronic condition can be related to the classical disease entity jalodara in Traditional Indian Medicine (Ayurveda). The present paper aims to evaluate the general potential of Ayurvedic therapy for overall clinical outcomes in hepatic cirrhosis complicated by ascites (HCcA). In form of a nonrandomized, uncontrolled, single group, open-label observational clinical study, 56 patients fulfilling standardized diagnostic criteria for HCcA were observed during their treatment at the P. D. Patel Ayurveda Hospital, Nadiad, India. Based on Ayurvedic tradition, a standardized treatment protocol was developed and implemented, consisting of oral administration of single and compound herbal preparations combined with purificatory measures as well as dietary and lifestyle regimens. The outcomes were assessed by measuring liver functions through specific clinical features and laboratory parameters and by evaluating the Child-Pugh prognostic grade score. After 6 weeks of treatment and a follow-up period of 18 weeks, the outcomes showed statistically significant and clinically relevant improvements. Further larger and randomized trials on effectiveness, safety, and quality of the Ayurvedic approach in the treatment of HCcA are warranted to support these preliminary findings.