Complementary Intervention for COVID-19

NCT04487964 | Completed

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Boswellia Serrata gum and Licorice extract are two nutritional agents that have pharmacological actions that could support the medical intervention for COVID-19. They have broad antiviral activity, anti-inflammatory, anti-lung injury, antibacterial activity, antithrombic formation, and immunomodulatory activity. The study will be conducted after January 18, 2017

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Increased number of people recovering from COVID-19

  Conversion of RT-PCR indicates positive for novel coronavirus RNA to negative

  14 days

Secondary Outcomes (2)

• Decrease number of patients that require respiratory support ,

  14 days

• Decrease duration of hospital stay

  7 days

Study Arms (2)

the conventional therapy according to the MOH protocol.

ACTIVE COMPARATOR

Patients who are receiving conventional therapy according to the MOH protocol.

Dietary Supplement: Licorice extract

conventional therapy +Liquorice cap and Boswellia Serrata gum

ACTIVE COMPARATOR

Patients will receive Liquorice cap and Boswellia Serrata gum in addition to conventional therapy

Dietary Supplement: Licorice extract

Interventions

Licorice extract DIETARY_SUPPLEMENT

LICORICE CAPSULES; 250 mg standardized extract (25% Glycyrrhizin - 62.5 mg) For 10 days, with measuring blood pressure daily. Dose: One capsule, twice daily, before meals. Boswellia serrata Gum Resin; B. serrate contains volatile oils (5-15%), pure resin (55-66%), and mucus (12-23%). The resin contains terpenoids, phenolic compounds, flavonoids, and phenylpropanoids. More than 12 different Boswellic acids have been identified, the amounts of 11-keto-β-boswellic acid KBA is 3-4.7% and acetyl-11-keto-β-boswellic acid(AKBA) is 2.2-2.9%, Dose: 2 gm, 4 times daily For 15 days, Boswellia Gum Resin is administered by chewing for a half-hour

Also known as: Boswellia serrata Gum

conventional therapy +Liquorice cap and Boswellia Serrata gum; the conventional therapy according to the MOH protocol.

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic and laboratory-confirmed diagnosis of COVID-19.
• RT-PCR indicates positive for novel coronavirus RNA
• Viral specific IgM and IgG are detectable in serum
• Viral specific IgG is detectable from negative to positive, OR
• Viral specific IgG antibody reaches a titration of at least 4-fold higher in the recovery stage than in the acute stage

You may not qualify if:

• Patients who are not fulfilling the diagnostic criteria for COVOID-19.
• Pregnant women.
• Critically ill patients who are mechanically ventilated since admission.
• Hypertensive patients.
• Congestive heart failure patients

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, Egypt

Location

Related Publications (23)

• Yu X, Bao Y, Meng X, Wang S, Li T, Chang X, Xu W, Yang G, Bo T. Multi-pathway integrated adjustment mechanism of licorice flavonoids presenting anti-inflammatory activity. Oncol Lett. 2019 Nov;18(5):4956-4963. doi: 10.3892/ol.2019.10793. Epub 2019 Sep 4.

  PMID: 31612007 BACKGROUND

• Mollica L, De Marchis F, Spitaleri A, Dallacosta C, Pennacchini D, Zamai M, Agresti A, Trisciuoglio L, Musco G, Bianchi ME. Glycyrrhizin binds to high-mobility group box 1 protein and inhibits its cytokine activities. Chem Biol. 2007 Apr;14(4):431-41. doi: 10.1016/j.chembiol.2007.03.007.

  PMID: 17462578 BACKGROUND

• Kong D, Wang Z, Tian J, Liu T, Zhou H. Glycyrrhizin inactivates toll-like receptor (TLR) signaling pathway to reduce lipopolysaccharide-induced acute lung injury by inhibiting TLR2. J Cell Physiol. 2019 Apr;234(4):4597-4607. doi: 10.1002/jcp.27242. Epub 2018 Sep 10.

  PMID: 30203548 BACKGROUND

• Ammon HP. Modulation of the immune system by Boswellia serrata extracts and boswellic acids. Phytomedicine. 2010 Sep;17(11):862-7. doi: 10.1016/j.phymed.2010.03.003. Epub 2010 Aug 8.

  PMID: 20696559 BACKGROUND

• Ammon HP. Boswellic Acids and Their Role in Chronic Inflammatory Diseases. Adv Exp Med Biol. 2016;928:291-327. doi: 10.1007/978-3-319-41334-1_13.

  PMID: 27671822 BACKGROUND

• Baram SM, Karima S, Shateri S, Tafakhori A, Fotouhi A, Lima BS, Rajaei S, Mahdavi M, Tehrani HS, Aghamollaii V, Aghamiri SH, Mansouri B, Gharahje S, Kabiri S, Hosseinizadeh M, Shahamati SZ, Alborzi AT. Functional improvement and immune-inflammatory cytokines profile of ischaemic stroke patients after treatment with boswellic acids: a randomized, double-blind, placebo-controlled, pilot trial. Inflammopharmacology. 2019 Dec;27(6):1101-1112. doi: 10.1007/s10787-019-00627-z. Epub 2019 Aug 12.

  PMID: 31407195 BACKGROUND

• Beghelli D, Isani G, Roncada P, Andreani G, Bistoni O, Bertocchi M, Lupidi G, Alunno A. Antioxidant and Ex Vivo Immune System Regulatory Properties of Boswellia serrata Extracts. Oxid Med Cell Longev. 2017;2017:7468064. doi: 10.1155/2017/7468064. Epub 2017 Mar 13.

  PMID: 28386311 BACKGROUND

• Eltahir HM, Fawzy MA, Mohamed EM, Alrehany MA, Shehata AM, Abouzied MM. Antioxidant, anti-inflammatory and anti-fibrotic effects of Boswellia serrate gum resin in CCl4-induced hepatotoxicity. Exp Ther Med. 2020 Feb;19(2):1313-1321. doi: 10.3892/etm.2019.8353. Epub 2019 Dec 19.

  PMID: 32010304 BACKGROUND

• Goswami D, Mahapatra AD, Banerjee S, Kar A, Ojha D, Mukherjee PK, Chattopadhyay D. Boswellia serrata oleo-gum-resin and beta-boswellic acid inhibits HSV-1 infection in vitro through modulation of NF-small ka, CyrillicB and p38 MAP kinase signaling. Phytomedicine. 2018 Dec 1;51:94-103. doi: 10.1016/j.phymed.2018.10.016. Epub 2018 Oct 16.

  PMID: 30466633 BACKGROUND

• Zhou X, Cai JG, Zhu WW, Zhao HY, Wang K, Zhang XF. Boswellic acid attenuates asthma phenotype by downregulation of GATA3 via nhibition of PSTAT6. Genet Mol Res. 2015 Jul 6;14(3):7463-8. doi: 10.4238/2015.July.3.22.

  PMID: 26214425 BACKGROUND

• Loeser K, Seemann S, Konig S, Lenhardt I, Abdel-Tawab M, Koeberle A, Werz O, Lupp A. Protective Effect of Casperome(R), an Orally Bioavailable Frankincense Extract, on Lipopolysaccharide- Induced Systemic Inflammation in Mice. Front Pharmacol. 2018 Apr 20;9:387. doi: 10.3389/fphar.2018.00387. eCollection 2018.

  PMID: 29731716 BACKGROUND

• Roy NK, Parama D, Banik K, Bordoloi D, Devi AK, Thakur KK, Padmavathi G, Shakibaei M, Fan L, Sethi G, Kunnumakkara AB. An Update on Pharmacological Potential of Boswellic Acids against Chronic Diseases. Int J Mol Sci. 2019 Aug 22;20(17):4101. doi: 10.3390/ijms20174101.

  PMID: 31443458 BACKGROUND

• Soni KK, Meshram D, Lawal TO, Patel U, Mahady GB. Fractions of Boswellia Serrata Suppress LTA4, LTC4, Cyclooxygenase-2 Activities and mRNA in HL-60 Cells and Reduce Lung Inflammation in BALB/c Mice. Curr Drug Discov Technol. 2021;18(1):95-104. doi: 10.2174/1570163817666200127112928.

  PMID: 31985381 BACKGROUND

• von Rhein C, Weidner T, Henss L, Martin J, Weber C, Sliva K, Schnierle BS. Curcumin and Boswellia serrata gum resin extract inhibit chikungunya and vesicular stomatitis virus infections in vitro. Antiviral Res. 2016 Jan;125:51-7. doi: 10.1016/j.antiviral.2015.11.007. Epub 2015 Dec 2.

  PMID: 26611396 BACKGROUND

• Cinatl J, Morgenstern B, Bauer G, Chandra P, Rabenau H, Doerr HW. Glycyrrhizin, an active component of liquorice roots, and replication of SARS-associated coronavirus. Lancet. 2003 Jun 14;361(9374):2045-6. doi: 10.1016/s0140-6736(03)13615-x.

  PMID: 12814717 BACKGROUND

• Redeploying plant defences. Nat Plants. 2020 Mar;6(3):177. doi: 10.1038/s41477-020-0628-0.

  PMID: 32170291 BACKGROUND

• Wang L, Yang R, Yuan B, Liu Y, Liu C. The antiviral and antimicrobial activities of licorice, a widely-used Chinese herb. Acta Pharm Sin B. 2015 Jul;5(4):310-5. doi: 10.1016/j.apsb.2015.05.005. Epub 2015 Jun 17.

  PMID: 26579460 BACKGROUND

• Sun ZG, Zhao TT, Lu N, Yang YA, Zhu HL. Research Progress of Glycyrrhizic Acid on Antiviral Activity. Mini Rev Med Chem. 2019;19(10):826-832. doi: 10.2174/1389557519666190119111125.

  PMID: 30659537 BACKGROUND

• Luo P, Liu D, Li J. Pharmacological perspective: glycyrrhizin may be an efficacious therapeutic agent for COVID-19. Int J Antimicrob Agents. 2020 Jun;55(6):105995. doi: 10.1016/j.ijantimicag.2020.105995. Epub 2020 Apr 24.

  PMID: 32335281 BACKGROUND

• Guo A, He D, Xu HB, Geng CA, Zhao J. Promotion of regulatory T cell induction by immunomodulatory herbal medicine licorice and its two constituents. Sci Rep. 2015 Sep 15;5:14046. doi: 10.1038/srep14046.

  PMID: 26370586 BACKGROUND

• Li X, He X, Liu B, Xu L, Lu C, Zhao H, Niu X, Chen S, Lu A. Maturation of murine bone marrow-derived dendritic cells induced by Radix Glycyrrhizae polysaccharide. Molecules. 2012 May 30;17(6):6557-68. doi: 10.3390/molecules17066557.

  PMID: 22728353 BACKGROUND

• Gomaa AA, Mohamed HS, Abd-Ellatief RB, Gomaa MA, Hammam DS. Advancing combination treatment with glycyrrhizin and boswellic acids for hospitalized patients with moderate COVID-19 infection: a randomized clinical trial. Inflammopharmacology. 2022 Apr;30(2):477-486. doi: 10.1007/s10787-022-00939-7. Epub 2022 Mar 1.

  PMID: 35233748 DERIVED

• Armanini D, Fiore C, Bielenberg J, Sabbadin C, Bordin L. Coronavirus-19: Possible Therapeutic Implications of Spironolactone and Dry Extract of Glycyrrhiza glabra L. (Licorice). Front Pharmacol. 2020 Oct 22;11:558418. doi: 10.3389/fphar.2020.558418. eCollection 2020.

  PMID: 33192504 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Glycyrrhiza glabra extract; Frankincense

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Adel A. Gomaa, Ph.D.

  Professor of Medical pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medical pharmacology

Model Details: Pilot study

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 27, 2020
• Study Start: January 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)