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临床试验/NCT03924596
NCT03924596Unknown1 期

Treatment of Renal Stones With Frankincense (Boswellic Acid): A Clinical Randomized Trial

Sultan Qaboos University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
100
试验地点
1
主要终点
Change in stone size (mm)

研究概览

简要总结

Frankincense, or olibanum, is the oleogum resin that is harvested from several different trees, an aromatic resin obtained from trees of the genus Boswellia. The word frankincense is derived from the ancient French name "frankincense," meaning "pure incense." Frankincense is also known in Arabic as "luban,". Luban has been reported to have anti-inflammatory, sedative, antibacterial, and anti-cancer activities. The aim of the present study is to treat renal stones with Luban (Boswellia) given as capsules of active oils.

This is a clinical Phase I & II (Safety, Efficacy) double-blind simple-randomized controlled treatment trial, where 100 participants with renal stones (50 Radiopaque and 50 Radiolucent stones) will be included in the study and divided between two treatment groups: Standard treatment (Uralyt-U) and new treatment (Luban). Participants with stone size less than 10 mm will be include; and participants with renal pathology or comorbidities (DM, CKD, multiple renal cysts, renal tumors) will be excluded. The outcome measures of the study will be: the primary end point (effect) is reduction of stone size by 50% or complete disappearance after 1 years of treatment; and the secondary end point (toxicity) is the participants intolerance of the treatment or development of side effects. If this study proves an effect of Luban on renal stones it will be an evolution in the management of renal stones by a natural, simple, harmless easily available method.

详细描述

Investigator Brochure of Olibanum (Boswellic Acid):

A. Clinical Research

Olibanum has been utilized as an important fixative in perfumes, soaps, creams, lotions, and detergents in the leading products of the perfume and cosmetic industry, as it has an oriental note in its scent. The interest of pharmaceutical companies created a third market for olibanum. Since ancient times, it has been used in folk medicine for its antiseptic, antiarthritic, and anti- inflammatory effects. For this reason, olibanum has gained increasing attention from scientists in the last 20 years to better define its medical effects and identify the constituents that are responsible for these effects.4 Animal studies and pilot clinical trials support the potential of B. serrata gum resin extract (BSE) for the treatment of a variety of inflammatory diseases like inflammatory bowel disease, rheumatoid arthritis, osteoarthritis and asthma.5 Moreover, in 2002 the European Medicines Agency classified BSE as an 'orphan drug' for the treatment of peritumoral brain oedema.6 The pharmacological effects of BSE have been mainly attributed to boswellic acids, especially 11-keto-b-boswellic acid (KBA) and acetyl-11-keto-b-boswellic acid (AKBA), which were proposed as selective 5-lipoxygenase (5-LO) inhibitors.7 Thus, instead of 5-LO inhibition by AKBA, inhibition of cathepsin G (catG) and acid might represent the principal mode of action of BSE.8 The gum resin is obtained by incision of the stem or branches of B. serrata. Following air-drying, the gum resin exudate consists of translucent, roundish or irregularly shaped, variable size pieces of up to 3 cm. The main components are volatile oils (5-15%), pure resin (55-66%) and mucus (12-23%). The gum resin typically contains 30% boswellic acids.9 The β-boswellic acid, is considered to be one of the main active components of frankincense. These are some of the chemical compounds present in frankincense: acid resin (56 per cent), soluble in alcohol and having the formula C20H32O4; gum (similar to gum Arabic) 30-36%; 3-acetyl-beta-boswellic acid (Boswellia sacra); alpha-boswellic acid (Boswellia sacra); 4-O-methyl-glucuronic acid (Boswellia sacra); incensole acetate phellandrene .The work of Ibn Sina (Avicenna) of the 11th century refers to the use of frankincense in inflammation and infection of the urinary tract.10 In Kenya it is used for dressing wounds and, when mixed with sesame oil, is taken to reduce the loss of blood in the urine from schistosomiasis infestation. The Antimicrobial activity of Boswellia resin have been suggested by studies.11 The biological activities of essential oils including: Antioxidant activity; Acetylcholinesterase inhibition; Antimicrobial activity and Antifungal activity.11 The antibacterial activity of oleo-gum resins of B. sacra, known as Hoojri, Najdi, Shathari, and Shaabi has been reported.3 All the four oils were effective against both Gram-positive and Gram-negative bacteria. The clinical isolates of Bacillus subtilis, Micrococcus luteus, Staphylococcus aureus, Klebsiella pneumoniae, and Enterobacter aerogenes were sensitive to all the oils, while those of Pseudomonas aeruginosa, Escherichia coli, and Proteus vulgaris were resistant to the Shathari, Najdi, and Hoojri oils, respectively.3 Anticancer activity: multiple pathways that could be activated by frankincense oil to induce bladder cancer cell death.12 The anti-inflammatory and analgesic activities of Boswellia serrata, and B. sacra have been reported.13 Recently It has been shown that the aqueous stem bark extract of Boswellia papyrifera oral administration has a Nephro-curative effects on acetaminophen-induced kidney damage in rats and that effect was found to be dose- and time- dependent.14 In addition, Oleo-gum-resin of Boswellia serrata Roxb induced Reno-protective action against Gentamicin induced nephrotoxicity in Albino rats.15 Also Zingiber officinale Roscoe (Ginger), Arabic gum (AG), and Boswellia have been found to be beneficial adjuvant therapy in participants with acute renal failure and CRF to prevent disease progression and delay the need for renal replacement therapy.16

B. Basic Research

Morphological studies of frankincense on kidney stones done at a preclinical setup, results attached in Appendix I.

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

入选标准

  • Participants with renal stones equal or less than 10mm in size

排除标准

  • Participants with renal pathology (Renal anomalies, multiple renal cysts, renal tumors)
  • Participants with comorbidities (DM, CKD)

研究组 & 干预措施

Luban Calcium Oxalate

Experimental

25 participants with radiopaque stones (Calcium Oxalate) treated with Luban (AKBA-Incense 2 capsules daily, 30% 3-acetyl-11-keto-ß-boswellic acid, from ZeinPharma)

干预措施: AKBA-Incense (3-acetyl-11-keto-ß-boswellic acid) (Drug)

Uralyt-U Calcium Oxalate

Active Comparator

25 participants with radiopaque stones (Calcium Oxalate) treated with Uralyt-U (Potassium Sodium Hydrogen Citrate, 10g orally in 3 divided doses with pH target 6.2-6.8)

干预措施: Potassium Sodium Hydrogen Citrate (Drug)

Luban Uric acid

Experimental

25 participants with radiolucent stones (Uric acid) treated with Luban (AKBA-Incense 2 capsules daily, 30% 3-acetyl-11-keto-ß-boswellic acid, from ZeinPharma)

干预措施: AKBA-Incense (3-acetyl-11-keto-ß-boswellic acid) (Drug)

Uralyt-U Uric acid

Active Comparator

25 participants with radiolucent stones (Uric acid) treated with Uralyt-U (Potassium Sodium Hydrogen Citrate, 10g orally in 3 divided doses with pH target 7.0-7.2

干预措施: Potassium Sodium Hydrogen Citrate (Drug)

结局指标

主要结局

Change in stone size (mm)

时间窗: 1 year

Decrease of stone size by 50%

次要结局

  • Number of participants with complications(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Salim Ahmed Al-Marhoon

Senior Consultant Urological Surgeon and Head of Urology

Sultan Qaboos University

研究点 (1)

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