Effectiveness and Safety of Rhea Health Tone® as add-on Therapy for COVID-19 in Hospitalized Adults in Indonesia

NCT04627519 | Unknown DMC

• 1 other identifier: Pharm-202010.01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Rhea Health Tone® as add-on therapy in hospitalized adults with COVID-19. The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any change would be accompanied by updated sample size. Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory (inflammatory biomarkers (IL-6, hs-CRP, IFNγ), SGOT, SGPT and Creatinine, conversion rate by PCR, QTc prolongation by ECG, chest X-ray), clinical (clinical assessment, vital sign, concomitant medication, other medical conditions) and safety assessment (serious adverse event). Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Rhea Health Tone®.

Conditions

Covid19

Keywords

Covid19; Rhea Health Tone

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Total days the subjects were hospitalized

  From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days

Secondary Outcomes (8)

• Duration of oxygenation

  From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days

• Duration of ventilation

  From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days

• PCR conversion

  Will be examined at days 1st , 7th, and 10th.

• Inflammatory biomarkers 1

  Will be examined at days 1st and 10th.

• Inflammatory biomarkers 2

  Will be examined at days 1st and 10th.

Study Arms (2)

SoC alone

NO INTERVENTION

Standard of Care alone (days 1 to 9)

Rhea Health Tone®

EXPERIMENTAL

Rhea Health Tone® 2 ml twice daily after meal (every 12 hours) for 9 days to be provided together with Standard of Care.

Dietary Supplement: Rhea Health Tone®

Interventions

Rhea Health Tone® DIETARY_SUPPLEMENT

Rhea Health Tone® 2 ml twice daily after the meal (every 12 hours)

Rhea Health Tone®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients aged ≥ 18 years to 50 years old, who recently admitted as in-patients and have not received any standard of care yet, with COVID-19 confirmed by PCR with mild to moderate symptoms.
• Female subjects of child-bearing age agree to take effective contraceptive measures during the study until seven days of the last oral medication of study product;
• Willing to receive a random assignment to any designated treatment group and not participating in another study at the same time;
• Willing for not using any other immunomodulator or treatment that might bias the study
• Patient willing to provide informed consent.

You may not qualify if:

• Any allergy to any composition of Rhea Health Tone®;
• Pregnant and breastfeeding;
• History and co-morbid of severe underlying disease where treatment and follow up is not likely to be beneficial to the patient based on physician judgment (e.g. retinopathy, cardiovascular disease (QTc \> 500 mdet (narrow QRS); QTc ≥ 550 mdet (wide QRS)), heart arrhythmia, uncontrolled diabetes mellitus, hypertension, chronic pulmonary disease, asthma, chronic kidney disease (Creatinine \> 2x upper limit of normal), liver disease (SGOT/SGPT \> 2x limit of normal), chronic neurological disease, or etc.). This includes people requiring care in designated supported living facilities and severe dementia;
• Possibility of being transferred to a non-study-hospital within 72 hours.
• History of autoimmune disease, cancer, HIV AIDS.

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• PT. Rhea Pharmaceutical Sciences Indonesia: collaborator
• Prodia Diacro Laboratories P.T.: collaborator

Study Sites (2)

Rumah Sakit Darurat Penanganan Covid-19 Wisma Atlet Kemayoran (RSDCWA)

Jakarta, DKI Jakarta, 14360, Indonesia

Location

Dr. Hasan Sadikin Central General Hospital

Bandung, West Java, 40161, Indonesia

Location

Related Publications (14)

• Stebbing J, Phelan A, Griffin I, Tucker C, Oechsle O, Smith D, Richardson P. COVID-19: combining antiviral and anti-inflammatory treatments. Lancet Infect Dis. 2020 Apr;20(4):400-402. doi: 10.1016/S1473-3099(20)30132-8. Epub 2020 Feb 27. No abstract available.

  PMID: 32113509 RESULT

• Tay MZ, Poh CM, Renia L, MacAry PA, Ng LFP. The trinity of COVID-19: immunity, inflammation and intervention. Nat Rev Immunol. 2020 Jun;20(6):363-374. doi: 10.1038/s41577-020-0311-8. Epub 2020 Apr 28.

  PMID: 32346093 RESULT

• Swamy MK, Akhtar MS, Sinniah UR. Antimicrobial Properties of Plant Essential Oils against Human Pathogens and Their Mode of Action: An Updated Review. Evid Based Complement Alternat Med. 2016;2016:3012462. doi: 10.1155/2016/3012462. Epub 2016 Dec 20.

  PMID: 28090211 RESULT

• Yang L, Peng K, Zhao S, Zhao F, Chen L, Qiu F. 2-methyl-L-erythritol glycosides from Gardenia jasminoides. Fitoterapia. 2013 Sep;89:126-30. doi: 10.1016/j.fitote.2013.05.018. Epub 2013 May 31.

  PMID: 23727470 RESULT

• Zhang Y, Yao J, Qi X, Liu X, Lu X, Feng G. Geniposide demonstrates anti-inflammatory and antiviral activity against pandemic A/Jiangsu/1/2009 (H1N1) influenza virus infection in vitro and in vivo. Antivir Ther. 2017;22(7):599-611. doi: 10.3851/IMP3152. Epub 2017 Mar 8.

  PMID: 28272019 RESULT

• Wu S, Patel KB, Booth LJ, Metcalf JP, Lin HK, Wu W. Protective essential oil attenuates influenza virus infection: an in vitro study in MDCK cells. BMC Complement Altern Med. 2010 Nov 15;10:69. doi: 10.1186/1472-6882-10-69.

  PMID: 21078173 RESULT

• Su S, Hua Y, Wang Y, Gu W, Zhou W, Duan JA, Jiang H, Chen T, Tang Y. Evaluation of the anti-inflammatory and analgesic properties of individual and combined extracts from Commiphora myrrha, and Boswellia carterii. J Ethnopharmacol. 2012 Jan 31;139(2):649-56. doi: 10.1016/j.jep.2011.12.013. Epub 2011 Dec 13.

  PMID: 22178177 RESULT

• Tipton DA, Lyle B, Babich H, Dabbous MKh. In vitro cytotoxic and anti-inflammatory effects of myrrh oil on human gingival fibroblasts and epithelial cells. Toxicol In Vitro. 2003 Jun;17(3):301-10. doi: 10.1016/s0887-2333(03)00018-3.

  PMID: 12781209 RESULT

• Nomicos EY. Myrrh: medical marvel or myth of the Magi? Holist Nurs Pract. 2007 Nov-Dec;21(6):308-23. doi: 10.1097/01.HNP.0000298616.32846.34.

  PMID: 17978635 RESULT

• Sharopov F, Valiev A, Satyal P, Gulmurodov I, Yusufi S, Setzer WN, Wink M. Cytotoxicity of the Essential Oil of Fennel (Foeniculum vulgare) from Tajikistan. Foods. 2017 Aug 28;6(9):73. doi: 10.3390/foods6090073.

  PMID: 28846628 RESULT

• Lee HS, Kang P, Kim KY, Seol GH. Foeniculum vulgare Mill. Protects against Lipopolysaccharide-induced Acute Lung Injury in Mice through ERK-dependent NF-kappaB Activation. Korean J Physiol Pharmacol. 2015 Mar;19(2):183-9. doi: 10.4196/kjpp.2015.19.2.183. Epub 2015 Feb 25.

  PMID: 25729281 RESULT

• Shalaby NM, Maghraby AS, el-Hagrassy AM. Effect of Daucus carota var. boissieri extracts on immune response of Schistosoma mansoni infected mice. Folia Microbiol (Praha). 1999;44(4):441-8. doi: 10.1007/BF02903720.

  PMID: 10983240 RESULT

• Alves-Silva JM, Zuzarte M, Goncalves MJ, Cavaleiro C, Cruz MT, Cardoso SM, Salgueiro L. New Claims for Wild Carrot (Daucus carota subsp. carota) Essential Oil. Evid Based Complement Alternat Med. 2016;2016:9045196. doi: 10.1155/2016/9045196. Epub 2016 Feb 14.

  PMID: 26981143 RESULT

• Yuan H, Ma Q, Cui H, Liu G, Zhao X, Li W, Piao G. How Can Synergism of Traditional Medicines Benefit from Network Pharmacology? Molecules. 2017 Jul 7;22(7):1135. doi: 10.3390/molecules22071135.

  PMID: 28686181 RESULT

Related Links

• Coronavirus
• Burhan E, Susanto A, Nasution S, Ginanjar E, Pitoyo C, Susilo A, et al. PROTOKOL TATALAKSANA COVID-19. 1st ed. Jakarta: Perhimpunan Dokter Paru Indonesia (PDPI); 2020.
• Pranita E. Sembuh dari Covid-19, Menurut WHO ini Rerata Waktu Penyembuhan Corona \[Internet\]. 2020
• Al-Samarrai O, Hameed R, Naji N. Studying of Phytochemical, Nutritive values and Antioxidant ability of Commiphora myrrha. Al-Mustansiriyh J Pharm Sciences. 2017;17(1):52-63.
• Phatak RS. Phytochemistry, Pharmacological Activities and Intellectual Property Landscape of Gardenia jasminoides Ellis: a Review. Pharmacogn J. 2015 Jul 8;7(5):254-65.
• urishi Y, Hamidi A, Zargar M, Singh S, Saxena A. Potential role of natural molecules in health and disease: Importance of boswellic acid. J Med Plants Res. 2010;4(2):2778-85.
• Imamu X, Yili A, Aisa HA, Maksimov VV, Veshkurova ON, Salikhov ShI. Chemical composition and antimicrobial activity of essential oil from Daucus carota sativa seeds. Chem Nat Compd. 2007 Jul;43(4):495-6.
• Shebaby WN. Evaluation of antioxidant, anticancer and immunomodulatory activities of wild carrot (Daucus carota ssp. carota) oil and its fractions. \[Disertation\]. University of Surrey; 2014.
• Djilani A, Ducko A. The Therapeutic Benefits of Essential Oils. Nutrition, Well-Being and Health
• ha R, Babikian Y, Babikian H, Khoa L, Wisoyo D, Srisombat S, et al. Efficacy of Natural Herbal Formulation against Acute Hepatopancreatic Necrosis Disease (AHPND) causing Vibrio parahaemolyticus in Penaeus vannamei
• Jha R, Babikian Y, Babikian H, Wisoyo S, Asih Y, Srisombat S, et al. Effectiveness of Natural Herbal Oil Formulation against White Spot Syndrome Virus in Penaeus vannamei. J Pharmacogn Nat Prod
• Al-Jameel WH, Al-Mahmood SS. Similarities and differences of COVID-19 and avian infectious bronchitis from molecular pathologist and poultry specialist view point. Iraqi Journal of Veterinary Sciences. 2020 May 15;
• Nadjib B.M. Effective Antiviral Activity of Essential Oils and their Characteristic Terpenes against Coronaviruses: An Update. Journal of Pharmacology \& Clinical Toxicology. 2020;8(1): 1138(19 March 2020)
• Maggo S. Dhull P, Dubey AP, Brashier, et. al. Cytokine Storm Syndrome in COVID-19: Diagnosis and Management Strategies. International Journal of Health Sciences and Research \[Internet\]. 2020 May;10(5)

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Keri Lestari, M.Si, S.Si, Apt.

Model Details: Participants will be randomised to be in Arm 1 or Arm 2 using pre-defined randomisation list; 1:1 for each arm. Arm 1 receives Standard of Care (day 1 to 10) Arm 2 receives Standard of Care + Rhea Health Tone (day 1 to 10)

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 13, 2020
• Study Start: December 9, 2020
• Primary Completion: May 19, 2021
• Study Completion: September 1, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)