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Treatment of Renal Stones With Frankincense (Luban) (Luban)

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ClinicalTrials.gov Identifier: NCT03924596
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Salim Ahmed Al-Marhoon, Sultan Qaboos University

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.


Condition or disease Intervention/treatment Phase
Renal Stones Drug: AKBA-Incense (3-acetyl-11-keto-ß-boswellic acid) Drug: Potassium Sodium Hydrogen Citrate Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Treatment of Renal Stones With Frankincense (Boswellic Acid): A Clinical Randomized Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Luban Calcium Oxalate
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)
AKBA-Incense 2 capsules daily, 30% 3-acetyl-11-keto-ß-boswellic acid, from ZeinPharma
Other Names:
  • Luban
  • Frankincense
  • Olibanum

Active Comparator: Uralyt-U Calcium Oxalate
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
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)
Other Name: Uralyt-U

Experimental: Luban Uric acid
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)
AKBA-Incense 2 capsules daily, 30% 3-acetyl-11-keto-ß-boswellic acid, from ZeinPharma
Other Names:
  • Luban
  • Frankincense
  • Olibanum

Active Comparator: Uralyt-U Uric acid
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
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)
Other Name: Uralyt-U




Primary Outcome Measures :
  1. Change in stone size (mm) [ Time Frame: 1 year ]
    Decrease of stone size by 50%


Secondary Outcome Measures :
  1. Number of participants with complications [ Time Frame: 1 year ]
    The participants intolerance of the treatment or development of side effects that are not known complications of the presence of stones or new adverse reactions



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924596


Locations
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Oman
Mohamed Salim Ahmed Al-Marhoon Not yet recruiting
Muscat, Oman, 123
Contact: Mohamed S Al-Marhoon    +968 95208801    msalmarhoon@gmail.com   
Sponsors and Collaborators
Sultan Qaboos University

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Responsible Party: Mohamed Salim Ahmed Al-Marhoon, Senior Consultant Urological Surgeon and Head of Urology, Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT03924596     History of Changes
Other Study ID Numbers: IG/DVC/MRC/19/03
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Salim Ahmed Al-Marhoon, Sultan Qaboos University:
Frankincense
Olibanum
Renal Stones
Kidney Stones
Renal Calculi
Kidney Calculi
Urinary Calculi
Urolithiasis
Boswellia
Boswellic acid
Clinical Trial

Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calcium, Dietary
Boswellic acid
Citric Acid
Sodium Citrate
Calcium
Uric Acid
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents