The Efficacy and Safety of Different Doses of Fermented Deglycyrrhizinated Licorice (FDGL) in the Management of Diabetic Neuropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
This study investigates the optimal dose of fermented deglycyrrhizinated licorice (FDGL) that maximizes both safety and efficacy in managing diabetic neuropathy complications in adults. The study is a single-center, double-blind, parallel, placebo-controlled randomized clinical trial where patients with diabetic neuropathy are randomized to receive placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily doses of FDGL for three months. The primary objective is to determine the percentage improvement of diabetic neuropathy presentations and pain scores at three months relative to baseline.
详细描述
This is a single-center, double-blinded, parallel, randomized clinical trial conducted at Al-Hussein University Hospital, Cairo, Egypt. Eligible patients are randomized to receive either placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily FDGL doses in a 1:1:1:1:1 ratio using block randomization with a block size of 5. The study employs computer-assisted random number generation for treatment allocation. Both patients and nurses are blinded to treatment allocation, with assignments kept in sealed envelopes opened only at enrollment. The study duration is 3 months with follow-up assessments at 1, 2, and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged between 18 and 70 years
- •Documented history of type I or type II diabetes mellitus
- •Confirmed diagnosis of at least one diabetes-related complication, including peripheral neuropathy
- •Diagnosis of peripheral neuropathy confirmed in both lower extremities
- •Numeric rating scores (VAS) on 0 to 10 scale ≥ 4 for at least 6 months in feet/legs
- •Ability to provide written informed consent
- •If using concurrent therapies for diabetic neuropathy (pregabalin, gabapentin, or duloxetine), must be on stable doses for at least 3 months prior to study start
排除标准
- •Concomitant chronic kidney disease
- •Hepatic impairment
- •Heart failure
- •Major psychiatric disorders
- •Pregnancy
- •Refusal to sign informed consent
- •Use of non-pharmacologic management strategies for diabetic neuropathy including:
- •TENS (Transcutaneous Electrical Nerve Stimulation)
- •Nerve block procedures
- •Acupuncture
- •Laser therapy
研究组 & 干预措施
Placebo
Matching placebo capsules administered daily for 3 months
干预措施: Fermented Deglycyrrhizinated Licorice (FDGL) (Drug)
FDGL 400 mg
Fermented Deglycyrrhizinated Licorice 400mg daily for 3 months
干预措施: Fermented Deglycyrrhizinated Licorice (FDGL) (Drug)
FDGL 800 mg
Fermented Deglycyrrhizinated Licorice 800mg daily for 3 months
干预措施: Fermented Deglycyrrhizinated Licorice (FDGL) (Drug)
FDGL 1000 mg
Fermented Deglycyrrhizinated Licorice 1000mg daily for 3 months
干预措施: Fermented Deglycyrrhizinated Licorice (FDGL) (Drug)
FDGL 1200 mg
Fermented Deglycyrrhizinated Licorice 1200mg daily for 3 months
干预措施: Fermented Deglycyrrhizinated Licorice (FDGL) (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: Baseline, 1 month, 2 months, and 3 months
The percentage improvement of diabetic neuropathy symptoms and pain scores (measured on a 0-10 scale where 0 = no pain and 10 = severe pain) at 3 months relative to baseline. This includes assessment of neuropathic complications in both lower extremities.
次要结局
- Incidence of adverse effects(Throughout the 3-month study period)
研究者
Mahmoud I Mostafa
Lecturer of Clinical Pharmacy
Helwan University