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Shengmai Liquid for Long COVID Fatigue: a Randomized Placebo-controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this clinical trial is to learn if Shengmai liquid works to treat Long Covid fatigue. It will also learn about the safety of Shengmai liquid. The main questions it aims to answer are: * Dose the Shengmai liquid will reduce the level of fatigue in the participants and reduce the fatigue scale score of the participants? * Dose the Shengmai liquid will reduce the level of anxiety and depression in the participants and improve the sleep quality and quality of life of the participants Researchers will compare Shengmai oral liquid to a placebo (a look-alike substance that contains no drug) to see if Shengmai liquid works to treat Long Covid fatigue. Participants will: * Take Shengmai liquid or a placebo every day for 8 weeks. * Visit the clinic once every 4 weeks for check up and test. There are a total of two telephone follow-ups, one follow-up 15 days after the treatment starts and another follow-up 30 days after the treatment ends. * Participants' medication responses and scale scores will be recorded.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged between 18 and 75 years;

• Meet the above diagnostic criteria;

• Meet the traditional Chinese medicine syndrome diagnostic criteria;

• Consent and sign the informed consent form

Locations
Other Locations
China
Beijing Di Tan Hospital, , Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Huijuan Cao, Professor
huijuancao327@hotmail.com
0086 +13466615885
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 100
Treatments
Experimental: Shengmai Liquid
For patients with Long COVID characterized by persistent fatigue who meet the inclusion and exclusion criteria, 100 patients will be randomly divided into a Shengmaiyin treatment group and a placebo control group using a random method. The Shengmaiyin treatment group will be given the traditional Chinese medicine Shengmaiyin oral liquid (produced by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with the approval number Z41021384. Ingredients: Codonopsis pilosula, Ophiopogon japonicus, Schisandra chinensis, excipients: sucrose, sodium benzoate, ethylparaben, specification 10m1/bottle), taken orally at a dose of 10ml per time, three times a day
Placebo_comparator: Placebo
The placebo group will be given a simulated Shengmaiyin oral liquid (provided by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with main ingredients water, brown sugar, flavoring agents, etc., specification 10m/bottle), 10ml per time, three times a day. The treatment course for Shengmaiyin or placebo will be 8 weeks (56 days), with follow-up continuing until 30 days after the end of the treatment course.
Related Therapeutic Areas
Sponsors
Collaborators: Institute of Chemistry - Vietnam Academy of Science and Technology, Beijing Ditan Hospital
Leads: Beijing University of Chinese Medicine

This content was sourced from clinicaltrials.gov