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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04847518
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : September 22, 2021
Sponsor:
Collaborators:
Tbilisi State Medical University
Phytomed AB
Information provided by (Responsible Party):
Swedish Herbal Institute AB

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.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Kan Jang capsules Other: Placebo capsules Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effect of Kan-Jang® Supplementation in Patients Diagnosed With COVID-19: A Randomized, Quadruple-blind, Placebo-controlled Trial
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kan Jang
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

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).
Other Name: Kan Jang fixed combination

Placebo Comparator: Placebo
70 patients take Placebo, two capsules three times a day for the two weeks in the treatment period
Other: Placebo capsules
Inactive excipients




Primary Outcome Measures :
  1. Duration of symptoms of mild COVID-19: number of days before symptoms disappear [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    Time (days) from randomization to symptoms disappear

  2. 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 Frame: Change from baseline during the period of the treatment and follow up (trough 21 days after randomization) ]
    Time (days) from randomization to the relief of total and individual mild COVID symptoms scores.

  3. Duration of infection [ Time Frame: from Day 1 to Day 14 after randomisation ]
    Time (days) from randomization to negative SARS-Cov-2 PCR test

  4. Number of participants clinically recovered [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    Number of participants (n) without symptoms of mild COVID


Secondary Outcome Measures :
  1. Severity of Respiratory symptoms and quality of life scores [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    Wisconsin Upper Respiratory Symptom Survey Questionary Score

  2. Cognitive performance test [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    d2-test of attention score

  3. Immune response marker [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    IL-6 concentration in the serum, pg/ml.

  4. Hypercoagulation marker [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization ]
    Dimer-D, ng/ml

  5. Inflammatory marker [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    C-reactive protein, mg/L

  6. Physical activity [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    Assessed by Habitual Physical Activity Questionnaire Score


Other Outcome Measures:
  1. Paracetamol intake [ Time Frame: Change from baseline during the period of the treatment and follow up (from Day 1 to Day 14 and day 21 after randomization) ]
    The number (n) of daily doses (4g) of paracetamol consumed during 14 days from randomization.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Patients with active cancer.
  • Taking immunosuppressive drugs (e.g., anti-rejection treatment after organ transplant);
  • Already participating in another clinical trial;
  • Has any other condition that would prevent safe participation in the study.

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): NCT04847518


Contacts
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Contact: Alexander Panossian, PhD +46733306226 ap@phytomed.se
Contact: Ramaz Shengeila, PhD, MD +995599565660 r.shengelia@tmsu.edu

Locations
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Georgia
The First University Clinic of Tbilisi State Medical University Recruiting
Tbilisi, Georgia, 0141
Contact: Levan Ratiani, PhD, MD    +995 593 305282    l.ratiani@tmsu.edu   
Contact: Elene Pachkoria, PhD, MD    +995 599 490 049    e.pachkoria@tsmu.edu   
Sponsors and Collaborators
Swedish Herbal Institute AB
Tbilisi State Medical University
Phytomed AB
Investigators
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Principal Investigator: Levan Ratiani, PhD, MD The First University Clinic of Tbilisi State Medical University
Publications:
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.

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Responsible Party: Swedish Herbal Institute AB
ClinicalTrials.gov Identifier: NCT04847518    
Other Study ID Numbers: SHIRD-2021-02
Nr3-2021/87 ( Registry Identifier: Registry Identifier: Biomedical Research Ethics Committee )
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases