The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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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. Our target population is adults (18-65 years old) with a COVID-19 infection history and have moderate to severe fatigue symptom at least 4 weeks after infection. The total sample size is 152. All participants will be randomly attributed to treatment group or placebo group in 1:1 ratio. The treatment duration is 4-week, and the follow-up period is also 4 weeks. Shenlingcao oral solution has been registered and marketed in mainland China, it is a safe product and pervious studies suggested it has anti-fatigue function. The primary efficacy outcome is the change of scores of Chalder fatigue scale (0-33 points) after 4-week treatment. The primary safety outcome is the number of adverse events. This study will be conducted in Hong Kong Baptist University Mr. \& Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre.

Conditions

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Long COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A double-blinded, placebo-controlled, randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

Shenlingcao Oral Liquid

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Shenlingcao Oral Liquid

Intervention Type DRUG

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

Interventions

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Shenlingcao Oral Liquid

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

Intervention Type DRUG

Other Intervention Names

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placebo of Shenlingcao Oral Liquid

Eligibility Criteria

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Inclusion Criteria

1. 18-65 years adults
2. Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC)
3. Chalder fatigue scale (0-11) not less than 4

Exclusion Criteria

1. 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.
2. Must chronically taking medicines that may affect the study results.
3. Severe obesity (BMI not less than 45)
4. Alcoholism or drug abuse
5. Allergy to Chinese medicine
6. Pregnancy, or plan to be pregnant, or lactating women

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No