Treatment of Renal Stones With Frankincense (Luban)

NCT03924596 | Unknown Phase 1 DMC

• 1 other identifier: IG/DVC/MRC/19/03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Stones

Keywords

Renal Stones; Kidney Stones; Renal Calculi; Kidney Calculi; Urinary Calculi; Urolithiasis; Frankincense; Olibanum; Boswellia; Boswellic acid; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Change in stone size (mm)

  Decrease of stone size by 50%

  1 year

Secondary Outcomes (1)

• Number of participants with complications

  1 year

Study Arms (4)

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)

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

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)

Drug: Potassium Sodium Hydrogen Citrate

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)

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

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

Drug: Potassium Sodium Hydrogen Citrate

Interventions

AKBA-Incense (3-acetyl-11-keto-ß-boswellic acid) DRUG

AKBA-Incense 2 capsules daily, 30% 3-acetyl-11-keto-ß-boswellic acid, from ZeinPharma

Also known as: Luban, Frankincense, Olibanum

Luban Calcium Oxalate; Luban Uric acid

Potassium Sodium Hydrogen Citrate DRUG

Uralyt-U (Potassium Sodium Hydrogen Citrate, 10g orally in 3 divided doses with pH target 6.2-6.8 for Calcium Oxalate stones and 7.0-7.2 for Uric Acid stones)

Also known as: Uralyt-U

Uralyt-U Calcium Oxalate; Uralyt-U Uric acid

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Mohamed Salim Ahmed Al-Marhoon

Muscat, 123, Oman

Location

MeSH Terms

Conditions

Nephrolithiasis; Kidney Calculi; Urinary Calculi; Urolithiasis

Interventions

Frankincense; Citrates

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant Urological Surgeon and Head of Urology

Study Record Dates

• First Submitted: April 20, 2019
• First Posted: April 23, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: February 1, 2021
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

OM (1)