A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia
Background: Benign Prostrate Hyperplasia (BPH) is a progressive disease of ageing men that may be associated with enlargement of the prostate and lower urinary tract symptoms (LUTS). Herbal/Nutraceutical formulations in addition to standard of care (SOC) could alleviate the symptoms, and thus improv...
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| Format: | Article |
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Elsevier
2024-09-01
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| Series: | Journal of Ayurveda and Integrative Medicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S097594762400086X |
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| author | Suresh B. Patankar Anupama Patankar Sagar Patankar Rajesh Raje Chandu Devanpally Pranjal Ausekar GauravPatil Shraddha Chitale |
| author_facet | Suresh B. Patankar Anupama Patankar Sagar Patankar Rajesh Raje Chandu Devanpally Pranjal Ausekar GauravPatil Shraddha Chitale |
| author_sort | Suresh B. Patankar |
| collection | DOAJ |
| description | Background: Benign Prostrate Hyperplasia (BPH) is a progressive disease of ageing men that may be associated with enlargement of the prostate and lower urinary tract symptoms (LUTS). Herbal/Nutraceutical formulations in addition to standard of care (SOC) could alleviate the symptoms, and thus improve the quality of life of patients. Objectives: To evaluate safety & efficacy of nutraceutical tablet as an adjuvant with SOC. Materials and Methods: This was a prospective, randomized two-arm study aimed to assess the safety and efficacy of Herbal/Nutraceutical Formulation (IP) + SOC versus only SOC, in BPH patients. The primary efficacy endpoint was the change in international prostate symptom score (IPSS) within and between two arms. The safety was evaluated in terms of adverse events and change in prostate specific antigen (PSA) levels. Results: 140 eligible patients (70 / arm) were evaluated for efficacy and safety endpoints. The baseline characteristics of patients in two arms differed nonsignificantly. The change in IPSS-storage, voiding and QoL scores, from day 1 to 90 were statistically significant in both the arms (p < 0.0001). However, by day 90, the change in these scores in SOC+IP arm were significantly higher than that of SOC arm. Further, the change in International Index of Erectile Function (IIEF) scores was significant in SOC+IP arm (p < 0.05), while non-significant in SOC arm. The adverse events non-significantly differed between two arms. Conclusion: The herbal/nutraceutical formulation combined with SOC are safe and effective for the treatment of BPH. The combination therapy was effective in reducing urine-related symptoms and improving the QoL of BPH patients. |
| format | Article |
| id | doaj-art-7e1472121e58433f9f47cd59f9b9bb22 |
| institution | Kabale University |
| issn | 0975-9476 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Ayurveda and Integrative Medicine |
| spelling | doaj-art-7e1472121e58433f9f47cd59f9b9bb222024-11-10T04:07:42ZengElsevierJournal of Ayurveda and Integrative Medicine0975-94762024-09-01155100971A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasiaSuresh B. Patankar0Anupama Patankar1Sagar Patankar2Rajesh Raje3Chandu Devanpally4Pranjal Ausekar5 GauravPatil6Shraddha Chitale7Ace Hospital and Research Centre, ASP Medical Foundation, Pune, MS, 411 004, India; Shripad Medisearch Pvt. Ltd., Pune, 411 004, India; Corresponding author. Ace Hospital and Research Centre, ASP Medical Foundation, Pune, MS, 411 004, India.Ace Hospital and Research Centre, ASP Medical Foundation, Pune, MS, 411 004, India; Sinhgad Dental College and Hospital, Pune, MS, IndiaAce Hospital and Research Centre, ASP Medical Foundation, Pune, MS, 411 004, India; Shripad Medisearch Pvt. Ltd., Pune, 411 004, IndiaAce Hospital and Research Centre, ASP Medical Foundation, Pune, MS, 411 004, India; Shripad Medisearch Pvt. Ltd., Pune, 411 004, IndiaArdent Clinical Research, Pune, IndiaArdent Clinical Research, Pune, IndiaArdent Clinical Research, Pune, IndiaArdent Clinical Research, Pune, IndiaBackground: Benign Prostrate Hyperplasia (BPH) is a progressive disease of ageing men that may be associated with enlargement of the prostate and lower urinary tract symptoms (LUTS). Herbal/Nutraceutical formulations in addition to standard of care (SOC) could alleviate the symptoms, and thus improve the quality of life of patients. Objectives: To evaluate safety & efficacy of nutraceutical tablet as an adjuvant with SOC. Materials and Methods: This was a prospective, randomized two-arm study aimed to assess the safety and efficacy of Herbal/Nutraceutical Formulation (IP) + SOC versus only SOC, in BPH patients. The primary efficacy endpoint was the change in international prostate symptom score (IPSS) within and between two arms. The safety was evaluated in terms of adverse events and change in prostate specific antigen (PSA) levels. Results: 140 eligible patients (70 / arm) were evaluated for efficacy and safety endpoints. The baseline characteristics of patients in two arms differed nonsignificantly. The change in IPSS-storage, voiding and QoL scores, from day 1 to 90 were statistically significant in both the arms (p < 0.0001). However, by day 90, the change in these scores in SOC+IP arm were significantly higher than that of SOC arm. Further, the change in International Index of Erectile Function (IIEF) scores was significant in SOC+IP arm (p < 0.05), while non-significant in SOC arm. The adverse events non-significantly differed between two arms. Conclusion: The herbal/nutraceutical formulation combined with SOC are safe and effective for the treatment of BPH. The combination therapy was effective in reducing urine-related symptoms and improving the QoL of BPH patients.http://www.sciencedirect.com/science/article/pii/S097594762400086XHerbal extractsNutraceuticalsBenign prostate hyperplasiaInternational prostate symptom score |
| spellingShingle | Suresh B. Patankar Anupama Patankar Sagar Patankar Rajesh Raje Chandu Devanpally Pranjal Ausekar GauravPatil Shraddha Chitale A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia Journal of Ayurveda and Integrative Medicine Herbal extracts Nutraceuticals Benign prostate hyperplasia International prostate symptom score |
| title | A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia |
| title_full | A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia |
| title_fullStr | A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia |
| title_full_unstemmed | A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia |
| title_short | A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia |
| title_sort | multi center randomized open label two arm study to evaluate safety amp efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia |
| topic | Herbal extracts Nutraceuticals Benign prostate hyperplasia International prostate symptom score |
| url | http://www.sciencedirect.com/science/article/pii/S097594762400086X |
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