NCT05684952

Brief Summary

This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

January 11, 2023

Last Update Submit

June 26, 2023

Conditions

Long COVID

Keywords

fatigueChinese herbal medicine

Outcome Measures

Primary Outcomes (1)

  • Fatigue: Change of scores in Chalder fatigue scale (0-33 points)

    The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.

    4 weeks

Secondary Outcomes (8)

  • Insomnia: Change of scores in Insomnia Severity Index (ISI)

    4 weeks

  • Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)

    4 weeks

  • Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)

    4 weeks

  • Muscle strength: Change of Hand Grip Strength (HGS)

    4 weeks

  • Long Covid related symptoms

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

Subjects need to take the Chinese herbal medicine (Shenlingcao oral liquid) 200 ml twice per day for 4 weeks. Shenlingcao oral solution is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.

Drug: Shenlingcao Oral Liquid

Control group

PLACEBO COMPARATOR

Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks.

Drug: Shenlingcao Oral Liquid

Interventions

Shenlingcao Oral LiquidDRUG

Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.

Also known as: placebo of Shenlingcao Oral Liquid
Control groupTreatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years adults
  • Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC)
  • Chalder fatigue scale (0-11) not less than 4

You may not qualify if:

  • Have any medical history that may cause fatigue before COVID-19 infection, which include but not limited to cardiovascular diseases, chronic lung diseases, dyspnea, cognitive diseases, psychological diseases, chronic liver or renal diseases, cancer, etc.
  • Must chronically taking medicines that may affect the study results.
  • Severe obesity (BMI not less than 45)
  • Alcoholism or drug abuse
  • Allergy to Chinese medicine
  • Pregnancy, or plan to be pregnant, or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Baptist University Chinese Medicine Clinic

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeFatigue

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A double-blinded, placebo-controlled, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 13, 2023

Study Start

May 30, 2023

Primary Completion

January 15, 2024

Study Completion

February 1, 2024

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations

CN(1)