A randomized, single-blind, placebo-controlled clinical trial to evaluate the efficacy of Glycyrrhiza glabra extract in participants with rheumatoid arthritis.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- 1. Achieving the American College of Rheumatology (ACR20) Responder Index It is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA)
研究概览
简要总结
RA is a chronic autoimmune disorder characterized by inflammation in the joints, leading to pain, swelling, stiffness, and eventual joint damage. Although current treatments such as disease-modifying Antirheumatic drugs (DMARDs) and biologics can be effective, they often come with significant side effects, including immunosuppression, gastrointestinal issues, and increased risk of infections. As a result, there is an increasing interest in complementary and alternative therapies, including herbal medicines, to manage RA. One such herb, Glycyrrhiza glabra (licorice), contains bioactive compounds such as glabridin, which have demonstrated anti-inflammatory, antioxidant, and immune-modulating properties. This clinical trial aims to investigate the therapeutic potential of glabridin as an adjunctive treatment for RA.
Despite advances in pharmacologic treatments, many RA participants continue to experience inadequate symptom control, side effects from long-term drug use, or a combination of both. Conventional RA therapies can also fail to address the underlying inflammation and immune dysregulation in some individuals. Therefore, there is a need for alternative treatments with a better safety profile that can complement existing therapies. Herbal medicines like Glycyrrhiza glabra (licorice), which have a long history of use in traditional medicine, may offer an innovative approach to improving disease management with fewer side effects. However, clinical evidence supporting its efficacy in RA remains limited, necessitating further investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female participants 30 to 60 years of age (both inclusive) who present RA (rheumatoid arthritis), diagnosed according to ACR or EULAR 2010 criteria with a total score of greater than equal to 6
- •Mild disease activity, indicated by a DAS 28 score greater than equal to 2.6 to smaller than 3.2
- •Participant exhibiting clinically apparent symptoms such as joint swelling and tenderness greater than equal 12 weeks.
- •Participants should have been diagnosed with rheumatoid arthritis within the past 3 months and their dose of disease-modifying antirheumatic drug(s) must have been stable for at least 8 weeks prior to trial participation.
- •Participants having VAS score in between 4 to 6 .
- •Willing to give informed consent for the study.
排除标准
- •Participants with other systemic complications of RA like rheumatic heart disease (RHD), rheumatic fever, pleural pericardial disease
- •Participants diagnosed with or history of dengue and chikungunya, other arthritis like, gouty arthritis, tuberculous arthritis etc.
- •However, participants with radiologically confirmed osteoarthritis (OA) may be excluded at the investigators discretion if the severity of osteoarthritis is judged to interfere with the study assessment
- •Participants undergoing physiotherapy or oil massages for pain relief.
- •Allergy, sensitivity, or contraindication to interventional product
- •Participants receiving anticoagulant and or antiplatelet agents (high dose aspirin (greater than 100 mg per day)
- •Participants who are unable to walk without support and or confined to a wheelchair
- •Participants with a history of or currently on a biologic (tumor necrosis factor blocking agents) or targeted synthetic DMARDs treatment or other biologic treatment
- •Use of corticosteroids within 2 weeks prior to study entry or planned use within 12 weeks of randomization
- •Chronic antibiotic therapy, if the investigator considers this may affect the safety of the participant or the assessment of the study results
- •History of psychiatric disorder that may impair the ability of the participant to provide written informed consent
- •A history presenting RA encompassing more than a year
- •Participation in any RA-related or any other trials involving investigational products within 30 days before the screening visit
- •Participants treated with any investigational drug in the preceding 4 weeks
- •Female participants with a positive pregnancy test or lactating
- •History of drug, alcohol abuse or dependence
- •Organ transplantation history
- •Participants unable to comply with the treatment regimen
- •Participant currently using any enzyme, nutraceutical, ayurvedic, herbal supplement for RA
- •Participants with any other condition that, in the opinion of the investigator, does not justify the inclusion of the participant in the study.
结局指标
主要结局
1. Achieving the American College of Rheumatology (ACR20) Responder Index It is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA)
时间窗: 1.At baseline and day 90. | 2.At screening, baseline, day 7, day 30, day 60 and day 90. | 3. At screening and day 90. | 4. At screening and day 90.
2. Changes in Visual Analogue Scale (VAS) pain score.
时间窗: 1.At baseline and day 90. | 2.At screening, baseline, day 7, day 30, day 60 and day 90. | 3. At screening and day 90. | 4. At screening and day 90.
3. Change in the Disease Activity Score Based on a 28-joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
时间窗: 1.At baseline and day 90. | 2.At screening, baseline, day 7, day 30, day 60 and day 90. | 3. At screening and day 90. | 4. At screening and day 90.
4. Changes in the levels of urinary CTX-II, serum hsCRP, s-CoLL2-1NO2,s-COMP.
时间窗: 1.At baseline and day 90. | 2.At screening, baseline, day 7, day 30, day 60 and day 90. | 3. At screening and day 90. | 4. At screening and day 90.
次要结局
- 1. Median of individual participants mean duration of morning joint stiffness based on a 7 day recall at baseline, and recorded in participant diaries .(2. Mean severity of morning joint stiffness using Numeric Rating Scale (NRS) based on a 7 day recall at baseline, and recorded in participant diaries .)
研究者
Dr Ameya Pathak
Sangvi Multispecialty Hospital Pvt. Ltd.