An Open-label, Multi-arm, Single-center Clinical Study to Evaluate the Safety and Efficacy of Polyherbal Extract as an Adjuvant Therapy in Subjects with Pre-diabetic, Moderately-diabetic, and Severely-diabetic Conditions.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- o Assesses long-term glycemic control over the 3-month treatment period
研究概览
简要总结
Brief Summary and Purpose of the Study
This is an open-label, multi-arm, single-center clinical trial designed to evaluate the efficacy and safety of a Polyherbal Extract as an adjuvant therapy in subjects with prediabetes, moderate diabetes, and severe diabetes. A total of 80 subjects will be enrolled and assigned to one of four study arms based on their glycemic status:
- Arms A, B, and C: Polyherbal Extract + Standard of Care (SOC)
- Arm D (Control): SOC only
The Polyherbal Extract is administered orally at 2 grams twice daily for 90 days alongside standard antidiabetic treatment (Metformin ± diet or insulin/other drugs as per physician).
The study aims to:
- Primary objectives:
- Evaluate the effect of the Polyherbal Extract on glycemic control by measuring HbA1c and Random Blood Sugar (RBS) from baseline to Day 90.
- Secondary objectives:
- Assess improvement in quality of life using the SF-36 questionnaire.
- Monitor safety and tolerability, including adverse events, vital signs, and liver/renal function tests.
This study addresses the limitations of conventional diabetes treatments by exploring a plant-based, integrative approach, leveraging traditional herbal medicine in combination with standard care. The findings may provide evidence for a safe and effective adjunct therapy for glycemic management in the Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Age between thirty and seventy-five years, of either gender.
- •Able and willing to provide written informed consent.
- •For subjects aged sixty years and above, audio-visual consent is mandatory as per regulatory requirements.
- •Diagnosed as: 3.1 Prediabetic (HbA1c between five point seven percent and six point four percent) 3.2 Moderately diabetic (HbA1c greater than or equal to six point five percent) 3.3 Severely diabetic (HbA1c greater than or equal to eight point zero percent)
- •Stable on current diabetes medication for the past four weeks, if applicable.
- •Willing to comply with study procedures and visit schedule.
排除标准
- •Diagnosis of any major systemic illness, including: 1.1 Malignancies 1.2 Chronic obstructive pulmonary disease (COPD) 1.3 Hepatobiliary disease 1.4 Severe cardiovascular disorders 1.5 Blood disorders
- •Known hyperlipidemia, hepatic dysfunction, renal dysfunction, or uncontrolled pulmonary dysfunction.
- •Poorly controlled hypertension.
- •Participation in any other clinical trial within the last three months.
- •Pregnant or lactating women.
- •Known allergy or intolerance to any component of the investigational product.
- •Unwillingness or inability to comply with study procedures or to sign informed consent.
- •Any condition that, in the investigator’s opinion, would interfere with study compliance or data interpretation.
结局指标
主要结局
o Assesses long-term glycemic control over the 3-month treatment period
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
2. Change in Random Blood Sugar (RBS)
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
- Evaluated from baseline to the end of the study using both:
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
- Laboratory-based RBS measurements (Visits 1, 2, 3)
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
- Weekly glucometer readings (pre- and post-breakfast) recorded in subject diaries
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
Statistical Methods:
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
- Within-group comparisons: Paired t-test or Wilcoxon signed-rank test
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
- Between-group comparisons: ANOVA (parametric) or Kruskal-Wallis test (nonparametric),
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
followed by post hoc tests if significant.
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
- Effect Size: Mean ± SD, 95% confidence intervals.
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
1. Change in Glycosylated Hemoglobin (HbA1c)
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
o Measured from baseline (Visit 4) to Day 90 (Visit 7)
时间窗: Screening Day -3, | Day -2 and Day -1 | Randomization/Baseline Day 0 | Day 30±2 Days, | Day 60±2 Days, | Day 90±2 Days, | Day 105±2 Days.
次要结局
- 1. Change in SF-36 Quality of Life scores(2. Descriptive analysis of improvement in physical and mental health domains)
研究者
Dr G M Prasad
Pranav Diabetes Center