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A randomized, double-blind, placebo-controlled, multi-center phase III clinical trial evaluating the efficacy and safety of Shufengjiedu Granules in the treatment of novel coronavirus infection (COVID-19)

A randomized, double-blind, placebo-controlled, multi-center phase III clinical trial evaluating the efficacy and safety of Shufengjiedu Granules in the treatment of novel coronavirus infection (COVID-19)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076084
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-09-26
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 infected disease

Interventions

Control Group:Shufeng Jiedu Placebo for 7 days, 2 bags/time, 3 times/day
Test Group:Shufeng Jiedu Granule for 7 days, 2 bags/time, 3 times/day

Sponsors

Shenzhen Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Age (18 = and =65) years old, gender is not limited; (2)Meet the diagnosis of The Pneumonia Diagnosis and Treatment Guideline for Novel Corona-virus Infection (Trial Version 10); (3)Clinical classification is mild; (4)Traditional Chinese medicine syndrome differentiation is Yidu Shubiao Syndrome; (5)Within 72 hours from the onset of COVID-19-related symptoms to random enrollment (details are provided in Supplemental Appendix 1); (6)At least one COVID-19-related symptom (cough, nasal congestion, sore throat, fever) score = 2 points : Cough Fatigue; Nausea; Dysgeusia Stuffy or Runny Nose; Headache; Vomit; Dysosmia Sore or Dry Throat; Fever; Diarrhea Shortness of Breath or Difficulty Breathing; Muscle or General Body Pain Chills or Shaking; (7) Volunteer to participate in this clinical trial, give informed consent and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) The clinical classification of COVID-19 is moderate, severe, and critical; (2) Combining diseases with the same clinical manifestations as COVID-19-related symptoms, such as influenza, infectious diseases with the above symptoms as prodromal symptoms, pneumonia, suppurative tonsillitis, acute tracheo-bronchitis, tuberculosis, and primary ciliary movement Dysfunction syndrome, other acute nasal diseases (such as allergic rhinitis, acute and chronic rhinitis, acute and chronic sinusitis, etc.), nasal mucosal dysfunction after nasal surgery or nasopharynx radiotherapy; (3) Patients with serious cardiovascular and cerebrovascular diseases (including hypertension with uncontrolled and stable blood pressure), chronic lung diseases, diabetes, chronic liver, kidney diseases, tumors and other basic diseases, as well as maintenance dialysis patients; (4) Immunodeficiency (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs lead to a state of hypoimmune function); (5) Obesity (body mass index = 30kg/m2); (6) Severe smoking (smoking severity index = 4 points); (7) Liver function ALT and AST exceed 2 times the upper limit of the normal reference value or Scr exceeds the upper limit of the normal reference value; (8) 4 hours before enrollment, used anti-new coronary pneumonia virus infection, cold medicine, antiviral medicine, antibiotics, antipyretic analgesics and other traditional Chinese medicines and chemical medicines that affect the evaluation of curative effect; (9) Combined with serious primary diseases such as hematopoietic system and mental illness; (10) Pregnancy or women who plan to become pregnant or breastfeeding during the study period; (11) History of allergy to the test drug ingredients; (12) History of long-term alcoholism and drug abuse; (13) Participated in other interventional drug clinical trials within the past month; (14) The investigator thinks patients who is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The time from initiation of treatment to patients’ COVID-19 related-symptoms sustained clinical recovery.;

Secondary

MeasureTime frame
The proportion of subjects who achieved sustained recovery of symptoms each day during the study;;Time from subject's initiation of treatment to sustained relief of COVID-19 symptoms;Other effectiveness evaluation indicators;

Countries

China

Contacts

Public ContactLU Hongzhou

Shenzhen Third People's Hospital

yangli@jirenjituan.com+86 189 3081 0088

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026