Effect of a polyherbal Unani formulation on left ventricular diastolic dysfunction in hypertensive patients – a randomized single blind placebo controlled clinical trial
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Asia Khanum
,
Mohd Riyazuddin
und
Mansoor Ahmad Siddiqui
Abstract
Objectives
Diastolic dysfunction represents an important pathophysiological intermediate between hypertension and heart failure. In the last two decades, the prevalence of heart failure patients having normal or near normal ejection fraction (EF) has increased to around 60 %. It thus poses a great morbidity and mortality risk to the population. In view of present scenario of high prevalence, lack of evidence-based therapy, and limited clinical trials, this study aimed to evaluate how a Unani formulation affects the improvement of the left ventricular diastolic function.
Methods
This clinical trial was set up as a randomized, placebo-controlled study involving 35 participants, with 18 individuals in the test group and 17 in the control group. Test group received 3.5 g of a polyherbal Unani formulation in capsule form along with 35 mL of an extract of Borago officinalis L. (Arq-e-Gaozaban), divided into two doses after meals. Meanwhile, the control group received a placebo in the same manner over an eight-week period. Follow-ups were conducted every 15 days to assess both subjective and objective parameters in all participants.
Results
The test formulation shows significant improvement in dyspnea and diastolic function from baseline to the end of trial (p<0.05), slight improvement in palpitations (p>0.05) and highly significant improvement in easy fatigability (p=0.001) as compared to the control.
Conclusions
The present study shows the effectiveness of the test drug in enhancing the diastolic function of left ventricle and alleviating other symptoms associated with ventricular diastolic dysfunction. Nevertheless, additional research with longer follow-up durations is necessary to clarify its efficacy and establish optimal treatment approaches for ventricular diastolic dysfunction in Unani medicine.
Acknowledgments
We are grateful to the patients for their cooperation and contribution to complete this study.
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Research ethics: The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013), ethical clearance obtained (IEC number NIUM/IEC/2017-18/003Moal/03, dated 19.07.2018).
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Informed consent: The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).
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Author contributions: Prof. M.A. Siddiqui and Mohd Riyazuddin conceived the idea and designed the study, oversaw data collection, analysis, and interpretation; Asia Khanam and Javed Ali collected the data and wrote the initial draft of the manuscript; Arisha Shahid analysed and interpreted the data, including statistical analysis; Arisha Shahid edited the manuscript. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: National Institute of Unani Medicine, Bangalore, India.
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Data availability: The raw data can be obtained on request from the corresponding author.
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© 2024 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Review
- The potential antibacterial effects of tea polyphenols
- Original Articles
- Bottom-up PBPK modeling of phenytoin brain disposition in postpartum newborns after intrauterine dosing
- Molecular pathogenesis of microsatellite instability-high early-stage colorectal adenocarcinoma in India
- Effect of a polyherbal Unani formulation on left ventricular diastolic dysfunction in hypertensive patients – a randomized single blind placebo controlled clinical trial
- Acute and sub-chronic oral GLP toxicity of Withania somnifera root extract in Sprague Dawley rats
- Short Communication
- Allelic frequencies of polymorphism c.521T>C (rs4149056) favor preemptive SLCO1B1 genotyping in Armenia
Artikel in diesem Heft
- Frontmatter
- Review
- The potential antibacterial effects of tea polyphenols
- Original Articles
- Bottom-up PBPK modeling of phenytoin brain disposition in postpartum newborns after intrauterine dosing
- Molecular pathogenesis of microsatellite instability-high early-stage colorectal adenocarcinoma in India
- Effect of a polyherbal Unani formulation on left ventricular diastolic dysfunction in hypertensive patients – a randomized single blind placebo controlled clinical trial
- Acute and sub-chronic oral GLP toxicity of Withania somnifera root extract in Sprague Dawley rats
- Short Communication
- Allelic frequencies of polymorphism c.521T>C (rs4149056) favor preemptive SLCO1B1 genotyping in Armenia
