Trial on Adverse Effects of Andrographis Paniculata in Type 2 Diabetes
Journal name: The Malaysian Journal of Medical Sciences
Original article title: Open Label Clinical Trial to Study Adverse Effects and Tolerance to Dry Powder of the Aerial Part of Andrographis Paniculata in Patients Type 2 with Diabetes Mellitus
The Malaysian Journal of Medical Sciences (MJMS) is a peer-reviewed, open-access journal published online at least six times a year. It covers all aspects of medical sciences and prioritizes high-quality research.
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Original source:
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Renu Agarwal, Siti Amrah Sulaiman, Mafauzy Mohamed
The Malaysian Journal of Medical Sciences:
(A peer-reviewed, open-access journal)
Full text available for: Open Label Clinical Trial to Study Adverse Effects and Tolerance to Dry Powder of the Aerial Part of Andrographis Paniculata in Patients Type 2 with Diabetes Mellitus
Year: 2005
Copyright (license): CC BY 4.0
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Summary of article contents:
Introduction
The study investigated the adverse effects and tolerance of dry powder from the aerial parts of Andrographis paniculata in 20 patients with type 2 diabetes mellitus over a 12-week period. Patients initially received 600 mg daily, with the dosage gradually increased to a maximum of 1.8 g daily. Key parameters monitored included body weight, blood pressure, liver and renal function tests, blood glucose levels, HbA1c, and other relevant biochemical markers. Informed consent was obtained from all participants, who were thoroughly evaluated for eligibility based on several criteria prior to enrollment.
Blood Glucose and HbA1c Outcomes
The clinical evaluation during the study revealed that most parameters remained stable throughout the trial, with no significant changes observed in body weight, blood pressure, or other health markers. However, a noteworthy decline of 5.46% in HbA1c was recorded, dropping from 8.61% at the screening visit to 8.13% by the end of the 12 weeks. This reduction signals a potential effectiveness of Andrographis paniculata in improving glycemic control among patients with type 2 diabetes, despite no concurrent significant changes in fasting blood glucose levels, suggesting that the herbal treatment may contribute to long-term glucose management.
Conclusion
Throughout the 12-week trial, the only reported adverse event was mild gastric irritation in one patient, which was successfully managed with antacid treatment. Overall, the investigation indicated that Andrographis paniculata is well tolerated among patients and shows promise in reducing HbA1c, indicating its potential role as an adjunctive treatment in managing type 2 diabetes mellitus. Additional studies with larger sample sizes may further elucidate its benefits and mechanisms of action in diabetes management.
FAQ section (important questions/answers):
What was the duration of the study on Andrographis paniculata's effects?
The study was conducted over a period of 12 weeks, during which 20 patients with type 2 diabetes mellitus were monitored for adverse effects and tolerance to dry powder of Andrographis paniculata.
What dosage of Andrographis paniculata was administered to participants?
Participants started with a dosage of 600 mg daily, which was gradually increased to a maximum of 1.8 grams daily, depending on their fasting blood glucose levels.
What significant change was observed in the patients' HbA1c levels?
The study reported a significant reduction in HbA1c levels, which decreased from 8.61% to 8.13% after 12 weeks, reflecting a 5.46% improvement in glycemic control.
Were there any notable adverse effects reported during the trial?
One patient experienced gastric irritation and nausea after taking the capsules. She received antacid treatment and continued participating in the trial without further issues.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Trial on Adverse Effects of Andrographis Paniculata in Type 2 Diabetes”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Visit:
In clinical trials, 'visit' refers to the scheduled appointments that participants attend to undergo assessments and collect data. The study monitored participants over seven visits, which involved evaluating health parameters and compliance, offering consistency and structure to the management and assessment of the herbal treatment's effects on patients.
2) Blood:
'Blood' is a vital component in medical research and diagnosis, as it carries oxygen, nutrients, and hormones throughout the body. In this study, various blood tests were performed to evaluate the safety and efficacy of Andrographis paniculata, measuring glucose levels, liver function, and hormonal responses, thereby guiding treatment evaluations.
3) Study (Studying):
'Study' refers to the structured investigation aiming to elucidate specific outcomes, in this case, the effects of Andrographis paniculata on type 2 diabetes patients. It employed a cohort of 20 individuals over 12 weeks, gathering data to analyze efficacy and side effects, and contributing to knowledge surrounding diabetes treatments.
4) Swallowing:
'Swallowing' is relevant as it describes the method by which participants consumed the powdered A. paniculata capsules. This process is crucial for ensuring proper intake of the herbal treatment. Difficulty in swallowing was noted as a potential issue, impacting patient compliance and the overall assessment of the treatment's effects.
5) Irritation:
'Irritation' signifies a minor adverse effect experienced by participants, specifically gastric irritation reported by one patient. Recognition of such symptoms is essential in clinical trials, as they can affect patient compliance and safety, informing researchers about the tolerability of treatments and guiding clinical recommendations for managing side effects.
6) Pregnant:
'Pregnant' designates a critical exclusion criterion in this study to ensure the safety of any potential mother and fetus. Since the effects of herbal treatments on pregnant or breastfeeding individuals are often unknown, such exclusions protect subjects’ health and ensure accurate data results specific to the studied population.
7) Nausea:
'Nausea' indicates a side effect reported by one participant during the trial. Documenting adverse effects like nausea is vital for assessing the tolerability of any treatment. Understanding the occurrence of nausea can influence the recommendation of dosages and formulations, leading to improved patient adherence and better treatment outcomes.
8) Powder:
'Powder' refers to the physical form of Andrographis paniculata used in the study. Administering herbal medicine in powder form can affect absorption and efficacy. The choice of powder capsules aims to standardize dosages, making it easier for participants to consume, while facilitating accurate measurements of treatment outcomes in the participants.
9) Sugar:
'Sugar' signifies an important variable in the study focusing on glucose management in type 2 diabetes. Monitoring blood sugar levels provides insights into the effectiveness of Andrographis paniculata on glycemic control. The measurement of sugar can inform adjustments in treatment strategies aimed at optimizing diabetes management and patient health outcomes.
10) Pulse:
'Pulse' represents the measurement of heart rate, an indicator of cardiovascular health. During trial visits, pulse rate was assessed alongside other physiological parameters to ensure participants' overall health status remained stable while receiving the herbal treatment. Tracking pulse aids in identifying any potential cardiovascular effects of the treatment.
Other Science Concepts:
Discover the significance of concepts within the article: ‘Trial on Adverse Effects of Andrographis Paniculata in Type 2 Diabetes’. Further sources in the context of Science might help you critically compare this page with similair documents:
Alp, Dose, Nausea, Andrographis paniculata, Compliance, Maximum Dose, Insulin, Adverse effect, Physical examination, Blood-pressure, Herbal treatment, Informed consent, Significant change, Clinical trial, Clinical evaluation, General physical examination, Systolic blood pressure, Diastolic blood pressure, Gastric irritation, Type 2 Diabetes Mellitus, BMI, Pulse Rate, Type 2 diabetes, HbA1c, Fasting blood glucose, Serum electrolyte, Body weight, Serum triglyceride, Liver function test, Written informed consent, Blood glucose, Study period, Renal function test, Haemogram, Cardiac Enzymes, LDH, Mean value, Adverse event, TSH, Overnight fasting, Blood cholesterol, Mean HbA1c, Dry powder, LFT, Mean fasting blood glucose, Baseline investigations, Add-on treatment.
Concepts being referred in other categories, contexts and sources.