Assessment of Efficacy of KAN-JANG® in Mild COVID-19

NCT04847518 | Unknown Phase 2 DMC

• 2 other identifiers: SHIRD-2021-02Nr3-2021/87
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The complexity of COVID-19 suggests a potential need for a range of therapies, including antiviral agents, immunostimulants, immunosuppressants, adaptogens, and anticoagulants. In this context, implementation of polyvalency drugs, which exhibit a wide range of biological activities and multitarget effects that is common for herbal medicines and specifically for Kan Jang, the fixed combination of Andrographis paniculata (Burm. F.) Wall. ex. Nees and Eleutherococcus senticosus (Rupr. \& Maxim.) Maxim which are known to exhibit antiviral, immunomodulatory, and anti-inflammatory effects and clinical efficacy in the respiratory tract of patients with infectious diseases. The purpose of this study is to provide scientific evidence on the effectiveness of Kan Jang for the treatment of mild COVID-19. We hypothesize that Kan Jang will have superior efficacy in amelioration COVID symptoms compared to placebo with a comparable safety profile to placebo. We hypothesize that Kan Jang will increase patients' recovery rate and decrease the duration of illness. The objective of the study is to assess the efficacy and tolerability of adjuvant treatment with Kan Jang for alleviating the severity of inflammatory symptoms (headache, loss of smell, gustatory dysfunction, rhinorrhea, nasal congestions, cough, sore throat, asthenia, myalgia, and fever) and shortening of their duration in mild COVID-19 patients.

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• Duration of symptoms of mild COVID-19: number of days before symptoms disappear

  Time (days) from randomization to symptoms disappear

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• The severity of the COVID-19 total and individual symptoms: headache, loss of smell, gustatory dysfunction, rhinorrhoea, nasal congestions, cough, sore throat, asthenia, myalgia, and fever

  Time (days) from randomization to the relief of total and individual mild COVID symptoms scores.

  Change from baseline during the period of the treatment and follow up (trough 21 days after randomization)

• Duration of infection

  Time (days) from randomization to negative SARS-Cov-2 PCR test

  from Day 1 to Day 14 after randomisation

• Number of participants clinically recovered

  Number of participants (n) without symptoms of mild COVID

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

Secondary Outcomes (6)

• Severity of Respiratory symptoms and quality of life scores

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Cognitive performance test

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Immune response marker

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

• Hypercoagulation marker

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization

• Inflammatory marker

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

Other Outcomes (1)

• Paracetamol intake

  Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization)

Study Arms (2)

Kan Jang

EXPERIMENTAL

70 patients take Kan Jang, two capsules three times a day for the two weeks in the treatment period. Daily dose - 90-120 mg of andrographolides.

Drug: Kan Jang capsules

Placebo

PLACEBO COMPARATOR

70 patients take Placebo, two capsules three times a day for the two weeks in the treatment period

Other: Placebo capsules

Interventions

Kan Jang capsules DRUG

One capsule contains a fixed combination of proprietary * Andrographis paniculata Nees. herb, native extract, DER native 4,5-8,0 :1 260 mg (Diterpene lactones andrographolide and 14-deoxy, 11,12- didehydroadnrograholide) 15-20 mg * Eleutherococcus senticosus (Rupr. et Maxim) Harms, root, native extract DER native 17-30:1 : 11.4 mg and other inactive excipients (Polycristalline cellulose, Magnesium stearate).

Also known as: Kan Jang fixed combination

Kan Jang

Placebo capsules OTHER

Inactive excipients

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laboratory confirmed (SARS-Cov-2 PCR-positive test) mild COVID-19 infection (in the last three days),
• COVID-19 patient in stable, moderate condition (i.e., not requiring Intensive Care Unit (ICU) admission).
• Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient).
• Able to take medication alone
• Able to give informed consent.

You may not qualify if:

• Pulmonary diseases
• Chronic pulmonary diseases
• Chronic rhinosinusitis
• Patient admitted already under invasive mechanical ventilation;
• The patient admitted with the severe acute respiratory syndrome and diagnosed with an etiologic agent other than Covid 19;
• Renal failure requiring dialysis or creatinine ≥ 2.0mg/dl;
• Tube feeding or parenteral nutrition.
• Respiratory decompensation requiring mechanical ventilation.
• Uncontrolled diabetes type 2.
• Hypertension stage 3,
• Autoimmune disease.
• Pregnant or lactating women.
• Patients are taking antibiotics for a reason other than COVID-19 at enrollment.
• Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid therapy, immunosuppressive pathology);
• Patients treated with chemo-radio-corticosteroid therapy in the last six months.

Sponsors & Collaborators

• Swedish Herbal Institute AB: lead
• Tbilisi State Medical University: collaborator
• Phytomed AB: collaborator

Study Sites (1)

The First University Clinic of Tbilisi State Medical University

Tbilisi, 0141, Georgia

RECRUITING

Related Publications (6)

• Panossian A, Brendler T. The Role of Adaptogens in Prophylaxis and Treatment of Viral Respiratory Infections. Pharmaceuticals (Basel). 2020 Sep 8;13(9):236. doi: 10.3390/ph13090236.

  PMID: 32911682 BACKGROUND

• Brendler T, Al-Harrasi A, Bauer R, Gafner S, Hardy ML, Heinrich M, Hosseinzadeh H, Izzo AA, Michaelis M, Nassiri-Asl M, Panossian A, Wasser SP, Williamson EM. Botanical drugs and supplements affecting the immune response in the time of COVID-19: Implications for research and clinical practice. Phytother Res. 2021 Jun;35(6):3013-3031. doi: 10.1002/ptr.7008. Epub 2020 Dec 29.

  PMID: 33373071 BACKGROUND

• Panossian A, Seo EJ, Wikman G, Efferth T. Synergy assessment of fixed combinations of Herba Andrographidis and Radix Eleutherococci extracts by transcriptome-wide microarray profiling. Phytomedicine. 2015 Oct 15;22(11):981-92. doi: 10.1016/j.phymed.2015.08.004. Epub 2015 Aug 20.

  PMID: 26407940 BACKGROUND

• Panossian A, Seo EJ, Efferth T. Effects of anti-inflammatory and adaptogenic herbal extracts on gene expression of eicosanoids signaling pathways in isolated brain cells. Phytomedicine. 2019 Jul;60:152881. doi: 10.1016/j.phymed.2019.152881. Epub 2019 Mar 10.

  PMID: 30987861 BACKGROUND

• Panossian A, Davtyan T, Gukassyan N, Gukasova G, Mamikonyan G, Gabrielian E, Wikman G. Effect of andrographolide and Kan Jang--fixed combination of extract SHA-10 and extract SHE-3--on proliferation of human lymphocytes, production of cytokines and immune activation markers in the whole blood cells culture. Phytomedicine. 2002 Oct;9(7):598-605. doi: 10.1078/094471102321616409.

  PMID: 12487323 BACKGROUND

• Panossian A, Wikman G. Efficacy of Andrographis paniculata in upper respiratory tract (URT) infectious diseases and the mechanism of action. In: Evidence and rational based research on Chinese Drugs, Ed. H Wagner and G Ulrich Merzenich (Eds.). Springer Publ. Comp.; 2012. 137-180.

  BACKGROUND

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 Officials

• Levan Ratiani, PhD, MD

  The First University Clinic of Tbilisi State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Panossian, PhD

CONTACT

+46733306226; ap@phytomed.se

Ramaz Shengeila, PhD, MD

CONTACT

+995599565660; r.shengelia@tmsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A Randomization Sequence of A and B from 1 to 140 will be generated by a qualified pharmacist (QP) at the manufacturing site before the study using a Random number generator. Treatment Randomization Sequence contains information about the distribution of unique random numbers between groups A and B. The QP will keep in secrecy for the clinic, and the investigators the Randomization Sequence and treatment code at the manufacturing site until the study is finalized. Study medications (boxes of placebo and Kan Jang capsules with identical appearance) will be labeled per Treatment Randomization Sequence. It will be provided to an independent statistician for statistical analysis of datasets when all patients complete the treatment. QP will disclose the treatment code providing the information about the actual assignment of treatments A and B to Kan Jang and placebo after statistical analysis of the results of a study where the data obtained from groups A and B will be compared.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a manner of 1:1 for study drug Kan Jang and Standard of Care to Placebo and Standard of Care (Paracetamol) The patient study period will last three weeks: active treatment for two weeks and a follow-up period for one week until Hospital discharge to check the side effects and study drug efficacy. During that time, patients will be monitored for adverse events.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: May 26, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)